A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

NCT04424316 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: C36710082019-002943-85
• Study Type: interventional
• Target: 14,727
• Locations: 18 countries
• Sites: 464

Brief Summary

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

Conditions

Respiratory Tract Infection

Keywords

Respiratory Tract infection; RSV; Vaccine; Maternal

Outcome Measures

Primary Outcomes (23)

• Percentage of Infant Participants With Medically Attended Lower Respiratory Tract Illness (MA-LRTI) Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: infant with an MA-RTI visit with age related fast breathing (respiratory rate \[RR\] more than or equal to \[\>=\] 60 breaths per minute \[bpm\] for less than \[\<\] 2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or oxygen saturation (SpO2) \<95 percent (%) or chest wall indrawing and RSV positive test results by reverse transcription-polymerase chain reaction (RT-PCR) testing of midturbinate nasal swab samples.

  Within 90 days after birth

• Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.

  Within 120 days after birth

• Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.

  Within 150 days after birth

• Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR \>=60 bpm for \<2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or SpO2 \<95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.

  Within 180 days after birth

• Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or intensive care unit (ICU) admission for more than (\>) 4 hours or failure to respond/unconscious.

  Within 90 days after birth

• Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for \>4 hours or failure to respond/unconscious.

  Within 120 days after birth

• Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for \>4 hours or failure to respond/unconscious.

  Within 150 days after birth

• Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)

  Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR \>=70 bpm for \<2 months of age \[\<60 days of age\], \>=60 bpm for \>=2 months to \<12 months of age, or \>=50 bpm for \>=12 months to 24 months of age) or SpO2 \<93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for \>4 hours or failure to respond/unconscious.

  Within 180 days after birth

• Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)

  AESI are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with pregnant maternal participants and their infants prior to/during delivery and at birth. For infant participants the following were considered as protocol defined AESIs: Preterm birth (born at \<37 weeks gestation); birth weight 1001-2500 grams; developmental delay; positive viral (polymerase chain reaction \[PCR\] or antigen-based) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), when not reported during MA-RTI visit, were reported as SARS-CoV-2 test positive. Extremely preterm birth (\<28 weeks) and extremely low birth weight (=\<1000 grams \[g\]) were reported as serious AESIs.

  From birth to 24 months of age

• Percentage of Infant Participants With Neonatal Deaths (Safety)

  Neonatal death was defined as the death of a live-born infant that occurred within a month after birth.

  Within 1 Month after birth

• Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)

  Congenital malformations/ anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life.

  At birth

• Percentage of Infant Participants With Other Neonatal Events (Safety)

  Other Neonatal problem included dysmaturity, neonatal illness, hospitalization, drug therapies, and neonatal death.

  Within 1 Month after birth

• Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)

  APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to \<7 was moderate, and \<4 was poor.

  1 minute after birth

• Number of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)

  APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to \<7 was moderate, and \<4 was poor.

  5 minutes after birth

• Number of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)

  APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to \<7 was moderate, and \<4 was poor.

  10 minutes after birth

• Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  From birth to 1 month of age

• Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From birth to 6 months of age

• Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From birth to 12 months of age

• Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From birth to 24 months of age

• Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination (Safety)

  Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit= 0.5 centimetre (cm). Redness and swelling were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for the severe pain at the injection site). Grade 4 reactions were classified by the investigator or medically qualified person.

  From Day 1 to Day 7 after vaccination

• Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination (Safety)

  Systemic events included: fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in an e-diary. Fever was defined as an oral temperature \>=38.0 degree Celsius \[C\]) and classified as mild (38.0 to 38.4), moderate (38.5 to 38.9), severe (39.0 to 40.0) and grade 4 (\>40.0 degree C). Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity). Vomiting: mild (1-2 times in 24 hours \[H\]), moderate (\>2 times in 24 H), severe (required intravenous \[IV\] hydration). Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (\>=6 in 24 H). For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by investigator or medically qualified person.

  From Day 1 to Day 7 after vaccination

• Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included in this outcome measure.

  From vaccination on Day 1 up to 1 month after vaccination

• Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.

  From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months)

Secondary Outcomes (3)

• Percentage of Infant Participants With Cases of Hospitalization Due to RSV Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

  Within 90, 120, 150, 180 and 360 days after birth

• Percentage of Infant Participants With MA-LRTI Cases Due to Any Cause With Protocol Defined Criteria Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

  Within 90, 120, 150, 180 and 360 days after birth

• Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy)

  Within 210, 240, 270 and 360 days after birth

Study Arms (2)

RSVpreF vaccine

EXPERIMENTAL

RSVpreF

Biological: RSVpreF

Placebo dose

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

RSVpreF BIOLOGICAL

RSV vaccine (RSVpreF)

RSVpreF vaccine

Placebo BIOLOGICAL

Placebo

Placebo dose

Eligibility Criteria

• Age: 0 Years - 49 Years
• Gender Eligibility Details: Healthy women ≤49 years of age who are between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Receiving prenatal standard of care based on country requirements.
• Had a fetal anomaly ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed.
• Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
• Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
• Expected to be available for the duration of the study and can be contacted by telephone during study participation.
• Participant is willing to give informed consent for her infant to participate in the study.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.
• Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study.
• Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Prepregnancy body mass index (BMI) of \>40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any related vaccine.
• Current pregnancy resulting from in vitro fertilization.
• Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:
• Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
• Placental abnormality.
• Polyhydramnios or oligohydramnios.
• Significant bleeding or blood clotting disorder.
• Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent.
• Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.
• Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:
• Prior preterm delivery ≤34 weeks' gestation.
• Prior stillbirth or neonatal death.
• Previous infant with a known genetic disorder or significant congenital anomaly.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (464)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Endocrinology and Internal Medicine Associates, PC

Birmingham, Alabama, 35205, United States

Location

OB/GYN Associates of Alabama, PC

Birmingham, Alabama, 35205, United States

Location

Sharp and Stone OB/GYN PC

Birmingham, Alabama, 35205, United States

Location

St Vincent's Hospital

Birmingham, Alabama, 35205, United States

Location

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

UAB Women & Infants Center - UAB Medicine

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham/Center for Women's Reproductive Health

Birmingham, Alabama, 35233, United States

Location

Cullman Clinical Research, Inc

Cullman, Alabama, 35058, United States

Location

Cullman Primary Care, PC

Cullman, Alabama, 35058, United States

Location

Cullman Regional

Cullman, Alabama, 35058, United States

Location

University of South Alabama Children's and Women's Hospital

Mobile, Alabama, 36604, United States

Location

USA Health Strada Patient Care Center

Mobile, Alabama, 36604, United States

Location

Springhill Medical Center

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research, Gulfport

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research - Pheonix

Phoenix, Arizona, 85006, United States

Location

Valleywise Comprehensive Health Center Women's Clinic

Phoenix, Arizona, 85008, United States

Location

Valleywise Health Medical Center

Phoenix, Arizona, 85008, United States

Location

Mesquite Pediatrics

Tucson, Arizona, 85712, United States

Location

Watching Over Mothers and Babies

Tucson, Arizona, 85712, United States

Location

Banner University Medical Center

Tucson, Arizona, 85724, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Banner University Medical Center ( North Campus )

Tucson, Arizona, 87519, United States

Location

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

St. Bernards OBGYN Associates

Jonesboro, Arkansas, 72401, United States

Location

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, 72401, United States

Location

The Children's Clinic of Jonesboro, PA

Jonesboro, Arkansas, 72401, United States

Location

Century Research Institute

Bellflower, California, 90706, United States

Location

Chowchilla Medical Center

Chowchilla, California, 93610, United States

Location

Loma Linda University Pediatric Clinic - Highland

Highland, California, 92346, United States

Location

Century Research Institute

Huntington Park, California, 90255, United States

Location

Matrix Clinical Research

Huntington Park, California, 90255, United States

Location

Chemidox Clinical Trials

Lancaster, California, 93534, United States

Location

Leonard S. Kurian, M.D., A Medical Corporation

Lancaster, California, 93534, United States

Location

Women & Infants Pavilion, Antelope Valley Hospital

Lancaster, California, 93534, United States

Location

Loma Linda University Adventist Health Sciences Center

Loma Linda, California, 92354, United States

Location

Loma Linda University Faculty Medical Clinics

Loma Linda, California, 92354, United States

Location

Loma Linda University Pediatric Clinics

Loma Linda, California, 92354, United States

Location

Loma Linda Unversity Children's Hospital

Loma Linda, California, 92354, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

St Mary Medical Center

Long Beach, California, 90806, United States

Location

Century Research Institute

Los Angeles, California, 90006, United States

Location

Matrix Clinical Research..

Los Angeles, California, 90006, United States

Location

East LA Doctors Hospital

Los Angeles, California, 90023, United States

Location

Hollywood Presbyterian Medical Center

Los Angeles, California, 90027, United States

Location

Century Research Institute

Los Angeles, California, 90033, United States

Location

White Memorial Medical Center

Los Angeles, California, 90033, United States

Location

Peter Morton Medical Building

Los Angeles, California, 90095, United States

Location

Ronald Reagan UCLA Medical Center Drug Information Center Dept

Los Angeles, California, 90095, United States

Location

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Affiliated Physician Practice

Madera, California, 93637, United States

Location

Charles E. Ugwu-Oju, M.D., F.A.C.O.G., Obstetrics & Gynecology

Madera, California, 93637, United States

Location

Madera Community Hospital

Madera, California, 93637, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Monterey Park Hospital

Monterey Park, California, 91754, United States

Location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Fomat- Raymond Poliakin, MD.

Thousand Oaks, California, 91360, United States

Location

Carey Chronis, MD

Ventura, California, 93003, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Anschutz Inpatient Pavilion 2

Aurora, Colorado, 80045, United States

Location

University of Colorado AO1

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital Inpatient Pavilion

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital Outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

University of Colorado Leprino Building

Aurora, Colorado, 80045, United States

Location

University of Colorado Research II Building

Aurora, Colorado, 80045, United States

Location

Delta Memorial Hospital

Delta, Colorado, 81416, United States

Location

Colorado Canyon's Hospital

Fruita, Colorado, 81521, United States

Location

Boeson Research

Grand Junction, Colorado, 81501, United States

Location

Dino-Peds

Grand Junction, Colorado, 81501, United States

Location

Women's Health Care of Western Colorado

Grand Junction, Colorado, 81501, United States

Location

Boeson Research

Grand Junction, Colorado, 81505, United States

Location

Community Hospital

Grand Junction, Colorado, 81505, United States

Location

SCL St. Mary's Medical Center

Grand Junction, Colorado, 81505, United States

Location

Montrose Memorial Hospital

Montrose, Colorado, 81401, United States

Location

Yale School Medicine Church Street Research Unit

New Haven, Connecticut, 06519, United States

Location

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20011, United States

Location

Axcess Medical Research

Loxahatchee Groves, Florida, 33470, United States

Location

North Shore Medical Center

Miami, Florida, 33150, United States

Location

Citadelle Clinical Research

North Miami Beach, Florida, 33162, United States

Location

A1 Imaging of Aventura

North Miami Beach, Florida, 33180, United States

Location

Baldwin Pediatrics

Panama City, Florida, 32405, United States

Location

Emerald Coast Obstetrics and Gynecology

Panama City, Florida, 32405, United States

Location

Emerald Coast Pediatrics

Panama City, Florida, 32405, United States

Location

Gulf Coast Regional Medical Center

Panama City, Florida, 32405, United States

Location

Rainbow Pediatrics

Panama City, Florida, 32405, United States

Location

Rainbow Pediatrics

Panama City Beach, Florida, 32407, United States

Location

American Research Centers of Florida

Pembroke Pines, Florida, 33027, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Investigational Drug Service

Atlanta, Georgia, 30322, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Piedmont Columbus Regional Midtown

Columbus, Georgia, 31901, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

1st Choice Urgent Care & Family Medicine

Blackfoot, Idaho, 83221, United States

Location

Bingham Memorial Hospital

Blackfoot, Idaho, 83221, United States

Location

Elite Clinical Trials LLLP

Blackfoot, Idaho, 83221, United States

Location

Grove Creek Medical Center

Blackfoot, Idaho, 83221, United States

Location

ASR, LLC

Boise, Idaho, 83702, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

St. Luke's Boise Medical Center

Boise, Idaho, 83712, United States

Location

West Valley Medical Center

Caldwell, Idaho, 83605, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho, 83404, United States

Location

Mountain View Hospital

Idaho Falls, Idaho, 83404, United States

Location

The Pediatric Center

Idaho Falls, Idaho, 83404, United States

Location

Saltzer Health

Meridian, Idaho, 83642, United States

Location

St. Luke's Meridian Medical Center

Meridian, Idaho, 83642, United States

Location

Saltzer Health

Nampa, Idaho, 83686, United States

Location

ASR, LLC

Nampa, Idaho, 83687, United States

Location

Saltzer Health

Nampa, Idaho, 83687, United States

Location

St. Alphonsus Medical Center- Nampa

Nampa, Idaho, 83687, United States

Location

St. Luke's Nampa Medical Center

Nampa, Idaho, 83687, United States

Location

Pocatello Women's Health Clinic

Pocatello, Idaho, 83201, United States

Location

Portneuf Medical Center

Pocatello, Idaho, 83201, United States

Location

1st Choice Urgent Care

Pocatello, Idaho, 83204, United States

Location

Clinical Research Prime Rexburg

Rexburg, Idaho, 83440, United States

Location

Elite Clinical Trials LLLP

Rexburg, Idaho, 83440, United States

Location

Madison Memorial Hospital

Rexburg, Idaho, 83440, United States

Location

The Pediatric Center

Rigby, Idaho, 83442, United States

Location

Dupont Pediatrics

Fort Wayne, Indiana, 46825, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Mary Greeley Medical Center

Ames, Iowa, 50010, United States

Location

Mcfarland Clinic PC

Ames, Iowa, 50010, United States

Location

McFarland Clinic, P.C.

Ames, Iowa, 50010, United States

Location

The Iowa Clinic

Ankeny, Iowa, 50023, United States

Location

Methodist West Hospital

West Des Moines, Iowa, 50266, United States

Location

The Iowa Clinic, P.C.

West Des Moines, Iowa, 50266, United States

Location

Alliance for Multispecialty Research, LLC

El Dorado, Kansas, 67042, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Owensboro Health Regional Hospital

Owensboro, Kentucky, 42303, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

The Women's Pavillion, P.S.C

Owensboro, Kentucky, 42303, United States

Location

Alexandria Cardiology Clinic - Secondary Research Site

Alexandria, Louisiana, 71301, United States

Location

Cambridge Medical Trials - Main Research Site

Alexandria, Louisiana, 71301, United States

Location

Cambridge Medical Trials

Alexandria, Louisiana, 71301, United States

Location

Rabie Clinic for Women

Alexandria, Louisiana, 71301, United States

Location

Rapides Regional Medical Center Labor and Delivery

Alexandria, Louisiana, 71301, United States

Location

Lakeview Regional Medical Center

Covington, Louisiana, 70433, United States

Location

St. Tammany Parish Hospital

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research

Covington, Louisiana, 70433, United States

Location

Ochsner Health Center - West Bank

Gretna, Louisiana, 70056, United States

Location

North Oaks Medical Center

Hammond, Louisiana, 70131, United States

Location

North Oaks Obstetrics & Gynecology

Hammond, Louisiana, 70403, United States

Location

North Oaks Rural Health Clinic

Hammond, Louisiana, 70403, United States

Location

MedPharmics LLC

Lafayette, Louisiana, 70508, United States

Location

Crescent City Physicians and Obstetrics

Metairie, Louisiana, 70005, United States

Location

MedPharmics LLC

Metairie, Louisiana, 70006, United States

Location

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

Location

Touro Infirmary

New Orleans, Louisiana, 70115, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Ochsner Health Center for Children

New Orleans, Louisiana, 70121, United States

Location

Women Under Study, LLC

New Orleans, Louisiana, 70125, United States

Location

Slidell Memorial Hospital

Slidell, Louisiana, 70458, United States

Location

Velocity Clinical Research

Slidell, Louisiana, 70458, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Investigational Pharmacy Service

Boston, Massachusetts, 02118, United States

Location

C.S. Mott Center

Detroit, Michigan, 48201, United States

Location

Hutzel-Harper Women's Hospital

Detroit, Michigan, 48201, United States

Location

University Health Center

Detroit, Michigan, 48201, United States

Location

Wayne State University Physician Group

Southfield, Michigan, 48034, United States

Location

Velocity Clinical Research

Gulfport, Mississippi, 39503, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Baer Pediatrics

St Louis, Missouri, 63131, United States

Location

KDB Enterprises

St Louis, Missouri, 63141, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Boeson Research (BUT)

Butte, Montana, 59701, United States

Location

St James Healthcare

Butte, Montana, 59701, United States

Location

Benefis Health System

Great Falls, Montana, 59405, United States

Location

Origin Health GTF

Great Falls, Montana, 59405, United States

Location

Boeson Research (GTF)

Great Falls, Montana, 59804, United States

Location

Marcus Daly Memorial Hospital

Hamilton, Montana, 59840, United States

Location

Boeson Research (HLN)

Helena, Montana, 59601, United States

Location

St Peters Health

Helena, Montana, 59601, United States

Location

Boeson Reseach (KAL)

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

The Birth Center

Missoula, Montana, 59803, United States

Location

Boeson Research LLC

Missoula, Montana, 59804, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Community Medical Center

Missoula, Montana, 59804, United States

Location

Community Physicians Group-Maternal Fetal Medicine

Missoula, Montana, 59804, United States

Location

St Luke Community Clinic - Ronan

Ronan, Montana, 59864, United States

Location

North Valley Hospital

Whitefish, Montana, 59937, United States

Location

Grand Island Regional Medical Center

Grand Island, Nebraska, 68801, United States

Location

CHI Health St. Francis

Grand Island, Nebraska, 68803, United States

Location

Meridian Clinical Research, LLC

Grand Island, Nebraska, 68803, United States

Location

Mary Lanning

Hastings, Nebraska, 68901, United States

Location

Meridian Clinical Research

Hastings, Nebraska, 68901, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68504, United States

Location

Midwest Children's Health Research Institute.

Lincoln, Nebraska, 68505, United States

Location

Bryan Health

Lincoln, Nebraska, 68506, United States

Location

Midwest Childrens Health Research Institute

Lincoln, Nebraska, 68516, United States

Location

Women's Health Care Center of Williamsburg

Lincoln, Nebraska, 68516, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68522, United States

Location

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, 68701, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Jaffe Family Womens Care Center

Camden, New Jersey, 08103, United States

Location

Pediatrics at Sheridan Pavilion- Three Cooper Plaza

Camden, New Jersey, 08103, United States

Location

Cooper Faculty OBGYN at Cherry Hill

Cherry Hill, New Jersey, 08034, United States

Location

Saint Peters University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Cooper Faculty OBGYN at Sewell

Sewell, New Jersey, 08080, United States

Location

MedPharmics

Albuquerque, New Mexico, 87102, United States

Location

Presbyterian Hospital

Albuquerque, New Mexico, 87106, United States

Location

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

Velocity Clinical Research, Albuquerque

Albuquerque, New Mexico, 87107, United States

Location

Lovelace Women's Hospital

Albuquerque, New Mexico, 87109, United States

Location

New York Presbyterian of Queens Hospital

Flushing, New York, 11355, United States

Location

Theresa Lang Children's Ambulatory Center

Flushing, New York, 11355, United States

Location

Fresh Meadows Family Health Center

Fresh Meadows, New York, 11365, United States

Location

Hollis Women's Center

Hollis, New York, 11423, United States

Location

Jackson Heights Family Health Center

Jackson Heights, New York, 11372, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

Women's Contemporary Care

Mineola, New York, 11501, United States

Location

Columbia Doctors

New York, New York, 10019, United States

Location

Audubon Clinic

New York, New York, 10032, United States

Location

Center for Prenatal Pediatrics

New York, New York, 10032, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Herbert Irving Pavilion

New York, New York, 10032, United States

Location

Morgan Stanley Childrens Hospital

New York, New York, 10032, United States

Location

Meridian Clinical Research LLC

Vestal, New York, 13850, United States

Location

UNC OB/GYN at Panther Creek (recruitment, randomization, administration of IP)

Cary, North Carolina, 27519, United States

Location

UNC Children's Hospital (Pediatric follow up)

Chapel Hill, North Carolina, 27514, United States

Location

UNC Healthcare (recruitment, randomization, administration of IP)

Chapel Hill, North Carolina, 27514, United States

Location

UNC OB/GYN at Weaver Crossing (recruitment, randomization, administration of IP)

Chapel Hill, North Carolina, 27514, United States

Location

Duke Children's Primary Care - Roxboro Street

Durham, North Carolina, 27704, United States

Location

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University.

Durham, North Carolina, 27705, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

FirstHealth Clinical Trials

Pinehurst, North Carolina, 28374, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

Sandhills Pediatrics

Seven Lakes, North Carolina, 27376, United States

Location

Sandhills Pediatrics

Southern Pines, North Carolina, 28387, United States

Location

FirstHealth Southern Pines Women's Health Center

Southern Pines, North Carolina, 28388, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati Medical Center Department of Obstetrics and Gynecology

Cincinnati, Ohio, 45219, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

HWC Women's Research Center, LLC

Englewood, Ohio, 45322, United States

Location

UC Health West Chester Hospital

West Chester, Ohio, 45069, United States

Location

Integris Yukon Hospital

Yukon, Oklahoma, 73099, United States

Location

Tekton Research

Yukon, Oklahoma, 73099, United States

Location

Allegheny Health and Wellness Pavilion

Erie, Pennsylvania, 16506, United States

Location

OBGYN Associates of Erie

Erie, Pennsylvania, 16507, United States

Location

Liberty Family Practice

Erie, Pennsylvania, 16508, United States

Location

Saint Vincent Hospital

Erie, Pennsylvania, 16544, United States

Location

Reading Hospital - Children's Health Center

West Reading, Pennsylvania, 19611, United States

Location

Reading Hospital - Women's Health Center

West Reading, Pennsylvania, 19611, United States

Location

Reading Hospital-Family Health Care Center

West Reading, Pennsylvania, 19611, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Bon Secours St. Francis Hospital

Charleston, South Carolina, 29414, United States

Location

Charleston 0B/GYN

Charleston, South Carolina, 29414, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

Prisma Health-Upstate Office of Maternal Fetal Medicine

Greenville, South Carolina, 29605, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Lowcountry Womens Specialists

Summerville, South Carolina, 29485, United States

Location

Summerville Medical Center

Summerville, South Carolina, 29485, United States

Location

Coastal Pediatric Research

Summerville, South Carolina, 29486, United States

Location

Sanford Obstetrics and Gynecology Clinic (Recruitment, Consenting, IP Administration, and Follow Up)

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Obstetrics and Gynecology Clinic

Sioux Falls, South Dakota, 57105, United States

Location

Sanford USD Medical Center (Main Hospital)

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Women's Health Plaza (Recruitment, Consenting, and Follow Up)

Sioux Falls, South Dakota, 57108, United States

Location

Premier Medical Group

Clarksville, Tennessee, 37040, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Texas Health Arlington Memorial Hospital

Arlington, Texas, 76012, United States

Location

Ventavia Research Group, LLC

Arlington, Texas, 76012, United States

Location

Medical City Arlington (Women's Hospital)

Arlington, Texas, 76015, United States

Location

St. David's Medical Center

Austin, Texas, 78705, United States

Location

Tekton Research, Inc.

Austin, Texas, 78705, United States

Location

Center for Women''s Health and Birthcare

Beaumont, Texas, 77702, United States

Location

Christus St. Elizabeth Hospital

Beaumont, Texas, 77702, United States

Location

Gadolin Research, LLC

Beaumont, Texas, 77702, United States

Location

Texas Health Harris Methodist Hospital Hurst-Euless-Bedford

Bedford, Texas, 76022, United States

Location

Child Care Pediatrics, P.A.

Burleson, Texas, 76028, United States

Location

Ventavia Research Group LLC

Burleson, Texas, 76028, United States

Location

Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

Location

Ventavia Research Group LLC

Dallas, Texas, 75231, United States

Location

Wise Health System Dectaur

Decatur, Texas, 76243, United States

Location

Cline Pediatrics

Dickinson, Texas, 77539, United States

Location

Doctor's Hospital Womens Hospital

Edinburg, Texas, 78539, United States

Location

South Texas Health System- Edinburg

Edinburg, Texas, 78539, United States

Location

8th Avenue Obstetrics & Gynecology

Fort Worth, Texas, 76104, United States

Location

Baylor Scott & White All Saints Medical Center

Fort Worth, Texas, 76104, United States

Location

Texas Health Harris Methodist Hospital Fort Worth

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Texas Health Harris Methodist Hospital Southwest

Fort Worth, Texas, 76132, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Chisholm Trail Pediatrics

Georgetown, Texas, 78626, United States

Location

FMC Science

Georgetown, Texas, 78626, United States

Location

St. David's Georgetown Hospital

Georgetown, Texas, 78626, United States

Location

Baylor Scott & White of Grapevine (Hospital)

Grapevine, Texas, 76051, United States

Location

Ventavia Research Group, LLC

Grapevine, Texas, 76051, United States

Location

Hany H. Ahmed, MD

Houston, Texas, 77008, United States

Location

HG Pediatrics

Houston, Texas, 77008, United States

Location

Van Tran Family Clinic

Houston, Texas, 77008, United States

Location

Ventavia Research Group, LLC

Houston, Texas, 77008, United States

Location

Memorial Hermann Memorial City

Houston, Texas, 77024, United States

Location

UT Health Women's Research Center at Memorial City

Houston, Texas, 77024, United States

Location

HCA: The Women's Hospital of Texas

Houston, Texas, 77054, United States

Location

Javara Inc.

Houston, Texas, 77054, United States

Location

Privia Medical Group Gulf Coast, PLLC

Houston, Texas, 77054, United States

Location

Texas Center for Drug Development, Inc

Houston, Texas, 77081, United States

Location

AdventHealth Family Medicine Rural Health Clinic, Inc.

Lampasas, Texas, 76550, United States

Location

FMC Science

Lampasas, Texas, 76550, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Diagnostic Clinic of Longview (Hollybrook)

Longview, Texas, 75605, United States

Location

Diagnostic Clinic of Longview (Medical Circle)

Longview, Texas, 75605, United States

Location

Longview Regional Medical Center

Longview, Texas, 75605, United States

Location

Rio Grande Regional Hospital

McAllen, Texas, 78503, United States

Location

South Texas Health System- McAllen

McAllen, Texas, 78503, United States

Location

Dr. Ruben Aleman and Associates

McAllen, Texas, 78504, United States

Location

Medical City Plano

Plano, Texas, 75075, United States

Location

Texas Health Presbyterian Hospital Plano

Plano, Texas, 75093, United States

Location

Ventavia Research Group LLC

Plano, Texas, 75093, United States

Location

St. Luke's Baptist Hospital

San Antonio, Texas, 78229, United States

Location

Tekton Research, LLC.

San Antonio, Texas, 78229, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Medical City Weatherford

Weatherford, Texas, 76086, United States

Location

Ventavia Research Group

Weatherford, Texas, 76086, United States

Location

Alpine Medical Group

Salt Lake City, Utah, 84102, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Old Farm Obstetrics & Gynecology, LLC

Salt Lake City, Utah, 84107, United States

Location

Holladay Family Practice

Salt Lake City, Utah, 84117, United States

Location

St. Marks Hospital

Salt Lake City, Utah, 84124, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Sentara Leigh Hospital

Norfolk, Virginia, 23502, United States

Location

The Group for Women

Norfolk, Virginia, 23502, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

Clinical Research Partners, LLC

North Chesterfield, Virginia, 23235, United States

Location

Virginia Commonwealth Univeristy Health Systems-Children's Pavilion

Richmond, Virginia, 23219, United States

Location

Virginia Commonwealth University Health System-Main Hospital

Richmond, Virginia, 23219, United States

Location

Virginia Commonwealth University Health System-Nelson Clinic

Richmond, Virginia, 23219, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

VCU Health Adult Outpatient Pavillion

Richmond, Virginia, 23298, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Tidewater Physicians for Women

Virginia Beach, Virginia, 23462, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

UW Neighborhood Ravenna Clinic

Seattle, Washington, 98105, United States

Location

UW Neighborhood South Lake Union Clinic

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center - Northwest

Seattle, Washington, 98133, United States

Location

UW Midwives Clinic at Northwest Outpatient Medical center

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center- Montlake

Seattle, Washington, 98195, United States

Location

UW Neighborhood Shoreline Clinic

Shoreline, Washington, 98133, United States

Location

MultiCare Health System - Mary Bridge Children's Health Center

Tacoma, Washington, 98405, United States

Location

Multicare Health System-Multicare Women's Center Tacoma

Tacoma, Washington, 98405, United States

Location

Multicare Health System-Pediatrics Northwest

Tacoma, Washington, 98405, United States

Location

Multicare Health System-Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Marshall Health

Huntington, West Virginia, 25701, United States

Location

University Physicians and Surgeons dba Marshall Health Department of Obstetrics and Gynecology

Huntington, West Virginia, 25701, United States

Location

University Physicians and Surgeons dba Marshall Health Department of Pediatrics

Huntington, West Virginia, 25701, United States

Location

Marshfield Medical Center - Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Medical Center

Marshfield, Wisconsin, 54449, United States

Location

Clínica del Niño y la Madre

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Hospital Italiano de Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Instituto de Maternidad y Ginecologia: "Nuestra Senora de las Mercedes"

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Sanatorio Mater Dei

Buenos Aires, 1425, Argentina

Location

Centro de Investigación Clinica OSECAC

Buenos Aires, C1040 AAL, Argentina

Location

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

CABA, C1426BOS, Argentina

Location

Hospital Publico Materno Infantil

Salta, 4400, Argentina

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Monash Children's Hospital

Clayton, Victoria, 3168, Australia

Location

Barwon Health, University Hospital Geelong

Geelong, Victoria, 3220, Australia

Location

Telethon Kids Institute

Nedlands, Western Australia, 6009, Australia

Location

St John of God Hospital Subiaco

Subiaco, Western Australia, 6008, Australia

Location

Hospital Universitario/GAMP - Grupo de Apoio a Medicina Preventiva e a Saude Publica

Canoas, Rio Grande do Sul, 92425-900, Brazil

Location

Hospital Moinhos de Vento - HMV

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital Moinhos de Vento - HMV

Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

Location

Maternidade Darcy Vargas

Joinville, Santa Catarina, 89202-190, Brazil

Location

Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica

Sorocaba, São Paulo, 18040-425, Brazil

Location

Canadian Center for Vaccinology - IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Hospital Base San José de Osorno (Servicio de Obstetricia y Ginecología)

Osorno, Los Lagos Region, 5311523, Chile

Location

Centro de Capacitación e Investigaciones Clínicas (CCIC)

Santiago, Santiago Metropolitan, 7510186, Chile

Location

Clinica Universidad de los Andes

Santiago, Santiago Metropolitan, 7620157, Chile

Location

Satellite (Deliveries): Hospital San Juan de Dios (Maternidad)

Santiago, Santiago Metropolitan, 8350488, Chile

Location

Instituto de Investigaciones Materno Infantil (IDIMI)

Santiago, Santiago Metropolitan, 8360160, Chile

Location

Deliveries (satellite): Hospital San Jose

Santiago, Santiago Metropolitan, 8380419, Chile

Location

Grupo Estudios Clínicos Infectología Respiratoria

Santiago, Santiago Metropolitan, 8380453, Chile

Location

Deliveries (satellite): Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Centro Internacional de Estudios Clinicos - CIEC

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Hospital Padre Hurtado

Santiago, Santiago Metropolitan, 8880465, Chile

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Odense Universitets Hospital

Odense, DK-5000, Denmark

Location

MeVac

Helsinki, 00290, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

Oulu Vaccine Research Clinic

Oulu, 90220, Finland

Location

Tampereen yliopisto Oulun Rokotetutkimusklinikka

Oulu, 90220, Finland

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Seinajoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Turku Vaccine Research Clinic

Turku, 20520, Finland

Location

Fukui Aiiku Hospital

Fukui-shi, Fukui, 910-0833, Japan

Location

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, Hyōgo, 660-8550, Japan

Location

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, 251-0041, Japan

Location

Rakuwakai Otowa Hospital

Kyoto, Kyoto, 607-8062, Japan

Location

Kuwana City Medical Center

Kuwana-shi, Mie-ken, 511-0061, Japan

Location

Sendai City Hospital

Sendai, Miyagi, 982-8502, Japan

Location

National Hospital Organization Beppu Medical Center

Beppu, Oita Prefecture, 874-0011, Japan

Location

Social Medical Corporation KARIYUSHIKAI Heartlife Hospital

Nakagami-gun, Okinawa, 901-2492, Japan

Location

Osaka Habikino Medical Center

Habikino, Osaka, 583-8588, Japan

Location

National Hospital Organization Tokyo Medical Center

Meguro-ku, Tokyo, 152-8902, Japan

Location

Saitama City hospital

Saitama, 336-8522, Japan

Location

Shizuoka General Hospital

Shizuoka, 420-8527, Japan

Location

Asociacion Mexicana para la Investigacion Clinica, A. C.

Pachuca, Hidalgo, 42070, Mexico

Location

Arke SMO S.A. de C.V.

Cuauhtémoc, Mexico City, 06700, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 64460, Mexico

Location

Hospital General de Durango

Durango, 34000, Mexico

Location

Arke SMO S.A. de C.V.

Veracruz, 91910, Mexico

Location

Spaarne Gasthuis (Kennemer Gasthuis)

Hoofddorp, 2134 TM, Netherlands

Location

Diakonessenhuis Utrecht

Utrecht, 3582 KE, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Botany Downs Primary Birthing Unit

Golflands, Auckland, 2013, New Zealand

Location

Papakura Primary Birthing Unit

Papakura North, Auckland, 2110, New Zealand

Location

Middlemore Hospital

Papatoetoe, Auckland, 2025, New Zealand

Location

Pukekohe Primary Birthing Unit

Pukekohe, Auckland, 2120, New Zealand

Location

New Zealand Clinical Research (Christchurch)

Christchurch, Canterbury, 8011, New Zealand

Location

Optimal Clinical Trials Ltd

Auckland, 1010, New Zealand

Location

Aotearoa Clinical Trials Trust (ACTT)

Auckland, 2025, New Zealand

Location

Christchurch Hospital (Canterbury District Health Board)

Christchurch, 8011, New Zealand

Location

Capital, Coast and Hutt Valley District- Wellington Regional Hospital

Wellington, 6021, New Zealand

Location

Asian Hospital and Medical Center

Muntinlupa City, National Capital Region, 1780, Philippines

Location

JOSHA Research

Bloemfontein, Free State, 9300, South Africa

Location

Wits RHI Shandukani Research Centre

Johannesburg, Gauteng, 2001, South Africa

Location

Into Research, West Wing Medical Centre

Pretoria, Gauteng, 0181, South Africa

Location

Setshaba Research Centre

Soshanguve, Gauteng, 0152, South Africa

Location

University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)

Soweto, Gauteng, 1862, South Africa

Location

Limpopo Clinical Research Initiative

Thabazimbi, Limpopo, 0380, South Africa

Location

MRC Unit on Child and Adolescent Health

Cape Town, Western Cape, 7700, South Africa

Location

Khayelitsha Satellite Site: Michael Mapongwana Community Health Centre

Khayelitsha, Western Cape, 7784, South Africa

Location

FAMCRU, University of Stellenbosch, Paediatric

Parow Valley, Western Cape, 7505, South Africa

Location

Kraaifontein Satellite site

Cape Town, 7570, South Africa

Location

Worcester Satellite site

Worcester, 6850, South Africa

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kyunghee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital de Antequera

Antequera, Malaga, 29200, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Madrid Puerta del Sur Mostoles

Móstoles, 28938, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Hsinchu MacKay Memorial Hospital

Hsinchu, 30071, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine

Fajara KMC, The Gambia

Location

Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine (LSHTM)

Sukuta, The Gambia

Location

Related Publications (8)

• Bolanos R, Araos R, Gonzalez C, Sepulveda D, Falconi JF, Averin A, Atwood M, Quinn E, Law AW, Mendes D. Cost-effectiveness of strategies using preventive interventions to protect infants in Chile from respiratory syncytial virus. Expert Rev Vaccines. 2025 Dec;24(1):904-913. doi: 10.1080/14760584.2025.2562201. Epub 2025 Oct 2.

  PMID: 40958705 DERIVED

• Ilangovan K, Radley D, Patton M, Shittu E, Lino MM, Goulas C, Swanson KA, Anderson AS, Gurtman A, Munjal I. Integrated Analysis of the Safety Experience in Adults with the Bivalent Respiratory Syncytial Virus Prefusion F Vaccine. Vaccines (Basel). 2025 Aug 1;13(8):827. doi: 10.3390/vaccines13080827.

  PMID: 40872913 DERIVED

• Simoes EAF, Pahud BA, Madhi SA, Kampmann B, Shittu E, Radley D, Llapur C, Baker J, Perez Marc G, Barnabas SL, Fausett M, Adam T, Perreras N, Van Houten MA, Kantele A, Huang LM, Bont LJ, Otsuki T, Vargas SL, Gullam J, Tapiero B, Stein RT, Polack FP, Zar HJ, Staerke NB, Padilla MD, Richmond PC, Sarwar UN, Baber J, Koury K, Lino MM, Kalinina EV, Li W, Cooper D, Anderson AS, Swanson KA, Gurtman A, Munjal I; MATISSE (Maternal Immunization Study for Safety and Efficacy) Clinical Trial Group. Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial. Obstet Gynecol. 2025 Feb 1;145(2):157-167. doi: 10.1097/AOG.0000000000005816. Epub 2025 Jan 2.

  PMID: 39746212 DERIVED

• Madhi SA, Kampmann B, Simoes EAF, Zachariah P, Pahud BA, Radley D, Sarwar UN, Shittu E, Llapur C, Perez Marc G, Maldonado Y, Kachikis A, Zar HJ, Swanson KA, Lino MM, Anderson AS, Gurtman A, Munjal I. Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine. Obstet Gynecol. 2025 Feb 1;145(2):147-156. doi: 10.1097/AOG.0000000000005817. Epub 2025 Jan 2.

  PMID: 39746206 DERIVED

• Nazareno AL, Wood JG, Muscatello DJ, Homaira N, Hogan AB, Newall AT. Estimating the cost-effectiveness of maternal respiratory syncytial virus (RSV) vaccination in Australia: A dynamic and economic modelling analysis. Vaccine. 2025 Feb 6;46:126651. doi: 10.1016/j.vaccine.2024.126651. Epub 2024 Dec 28.

  PMID: 39733477 DERIVED

• Otsuki T, Akada S, Anami A, Kosaka K, Munjal I, Baber J, Shoji Y, Aizawa M, Swanson KA, Gurtman A. Efficacy and safety of bivalent RSVpreF maternal vaccination to prevent RSV illness in Japanese infants: Subset analysis from the pivotal randomized phase 3 MATISSE trial. Vaccine. 2024 Sep 17;42(22):126041. doi: 10.1016/j.vaccine.2024.06.009. Epub 2024 Jun 8.

  PMID: 38853036 DERIVED

• Kampmann B, Madhi SA, Munjal I, Simoes EAF, Pahud BA, Llapur C, Baker J, Perez Marc G, Radley D, Shittu E, Glanternik J, Snaggs H, Baber J, Zachariah P, Barnabas SL, Fausett M, Adam T, Perreras N, Van Houten MA, Kantele A, Huang LM, Bont LJ, Otsuki T, Vargas SL, Gullam J, Tapiero B, Stein RT, Polack FP, Zar HJ, Staerke NB, Duron Padilla M, Richmond PC, Koury K, Schneider K, Kalinina EV, Cooper D, Jansen KU, Anderson AS, Swanson KA, Gruber WC, Gurtman A; MATISSE Study Group. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023 Apr 20;388(16):1451-1464. doi: 10.1056/NEJMoa2216480. Epub 2023 Apr 5.

  PMID: 37018474 DERIVED

• Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.

  PMID: 34774184 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: PfizerClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded, placebo-controlled study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: June 17, 2020
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

KR (4); AU (5); NZ (9); TW (5); BR (5); DK (4); ES (6); TH (2); AR (8); PH (1); ZA (11); CL (10); ME (5); CA (3); US (363); FI (8); JP (12); NL (3)