NCT04032093|CompletedPhase 2ResultsDMCFDA Drug

A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN

A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS

Pfizer ClinicalTrials.gov

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1 other identifier

C3671003

Study Type

interventional

Target

1,153

Locations

5 countries

Sites

159

Timeline

RegisteredJul 2019

StartedAug 2019

CompletionSep 2021

Brief Summary

This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,153

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2019

Geographic Reach

5 countries

159 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

July 22, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed

13 days until next milestone

Study Start

First participant enrolled

August 7, 2019

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed

1 year until next milestone

Results Posted

Study results publicly available

October 18, 2022

Completed

Last Updated

October 18, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

July 22, 2019

Results QC Date

September 20, 2022

Last Update Submit

September 20, 2022

Conditions

Respiratory Tract Infection

Keywords

Respiratory tract infectionRespiratory Syncytial VirusRSVVaccine

Outcome Measures

Primary Outcomes (8)

Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.
Within 7 days after vaccination
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\>=38.0 to 38.4 degrees \[deg\] Celsius \[C\]), grade 2: moderate (\>38.4 to 38.9 deg C), grade 3: severe (\>38.9 to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.
Within 7 days after vaccination
Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Within 1 month after vaccination
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement.
From day of vaccination (Day 1) up to 12 months post-delivery
Percentage of Infant Participants With Specific Birth Complications
Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.
At birth
Percentage of Infant Participants With Any AE Within 1 Month of Age
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Within 1 month after birth
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Within 12 months after birth
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented.
Within 12 months after birth

Secondary Outcomes (3)

Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
Before vaccination, 2 weeks and 1 month after vaccination and at delivery
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
2 weeks and 1 month after vaccination, at delivery
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
At birth and at 1, 2, 4, 6 months after birth

Study Arms (5)

RSV dose with aluminum hydroxide

EXPERIMENTAL

RSV vaccine with aluminum hydroxide

Biological: RSV vaccine

RSV dose without aluminum hydroxide

EXPERIMENTAL

RSV vaccine without aluminum hydroxide

Biological: RSV vaccine

Higher RSV dose with aluminum hydroxide

EXPERIMENTAL

Higher dose level RSV vaccine with aluminum hydroxide

Biological: RSV vaccine

Higher RSV dose without aluminum hydroxide

EXPERIMENTAL

Higher dose level RSV vaccine without aluminum hydroxide

Biological: RSV vaccine

Placebo dose

PLACEBO COMPARATOR

Normal saline solution for injection (0.9% sodium chloride injection)

Biological: Placebo

Interventions

RSV vaccineBIOLOGICAL

RSV vaccine

Higher RSV dose with aluminum hydroxideHigher RSV dose without aluminum hydroxideRSV dose with aluminum hydroxideRSV dose without aluminum hydroxide

PlaceboBIOLOGICAL

Normal saline solution for injection (0.9% sodium chloride injection)

Placebo dose

Eligibility Criteria

Age18 Years - 49 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsHealthy women 18 to 49 years of age who are between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Receiving prenatal standard of care.
Had an ultrasound performed at \>=18 weeks of pregnancy.
Had a negative urinalysis for protein and glucose at the screening visit. Trace protein in the urine is acceptable if the blood pressure is also normal.
Documented negative human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.
Body mass index of \</=40 kg/m2 at the time of the screening visit.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol.
Expected to be available for the duration of the study and willing to give informed consent for her infant to participate in the study.
Evidence of a signed and dated ICD signed by the parent(s).
Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

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 to any component of the investigational product or any related vaccine.
History of latex allergy.
History of any severe allergic reaction.
Participants with known or suspected immunodeficiency.
Current pregnancy resulting from in vitro fertilization or other assisted reproductive technology.
A prior history of or known current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in and completion of the study.
Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
Participant with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
Participants who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or planned receipt of such treatment or agents during study participation. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before investigational product administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Current alcohol abuse or illicit drug use.
Receipt of blood or plasma products or immunoglobulin, from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
+3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (159)

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

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

Arrowhead Hospital

Glendale, Arizona, 85308, United States

Location

Abrazo West Campus Hospital

Goodyear, Arizona, 85395, United States

Location

St. Joseph Hospital

Phoenix, Arizona, 85013, United States

Location

MedPharmics, LLC

Phoenix, Arizona, 85015, United States

Location

Mesquite Pediatrics

Tucson, Arizona, 85712, United States

Location

Watching Over Mothers and Babies

Tucson, Arizona, 85712, United States

Location

Join Clinical Trials

Bellflower, California, 90706, United States

Location

Chowchilla Hospital Clinic

Chowchilla, California, 93610, United States

Location

Join Clinical Trials

Huntington Park, California, 90255, United States

Location

Matrix Clinical Research

Huntington Park, California, 90255, United States

Location

Join Clinical Trials

Los Angeles, California, 90006, United States

Location

East Los Angeles Doctors Hospital

Los Angeles, California, 90023, United States

Location

White Memorial Medical Center

Los Angeles, California, 90033, United States

Location

Join Clinical Trials

Los Angeles, California, 90036, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Affiliated Physician Practice

Madera, California, 93637, United States

Location

Charles E. Ugwu-Oju, MD, FACOG

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

Children's Hospital Colorado