Study Stopped
Study vaccinations and blood draws were halted due to adequacy of a smaller dataset and study feasibility issues. It was not based on any safety concerns.
Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
2 other identifiers
interventional
565
1 country
48
Brief Summary
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
48 active sites
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
First Submitted
Initial submission to the registry
May 25, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedResults Posted
Study results publicly available
November 30, 2021
CompletedNovember 30, 2021
November 1, 2021
2.4 years
May 25, 2018
October 20, 2021
November 29, 2021
Conditions
Outcome Measures
Primary Outcomes (15)
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 Days After Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 Days After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 Days After Dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 Days After Dose 4
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD)
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Within 7 Days After Supplemental Dose
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (\>=) 38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Within 7 Days After Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Within 7 Days After Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Within 7 Days After Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Within 7 Days After Dose 4
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Within 7 Days After Supplemental Dose
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)
Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)
Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study
An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
From Dose 1 to End of the Study (up to duration of 17 months)
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects.
From Dose 1 to End of the Study (up to duration of 17 months)
Secondary Outcomes (3)
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3
1 Month After Dose 3
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
1 Month after Dose 3
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4
1 Month After Dose 4
Study Arms (3)
Group 1 - Coadministration
EXPERIMENTALMultivalent pneumococcal conjugate vaccine coadministered with Prevnar 13
Group 2 - Staggered Administration
EXPERIMENTALMultivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13
Group 3 - Control with Supplemental Dose
ACTIVE COMPARATORPrevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine
Interventions
Pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Eligibility Criteria
You may qualify if:
- Male or female infant born at \>36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
- Healthy infant determined by medical history, physical examination, and clinical judgment.
You may not qualify if:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
- Previous receipt of \>1 dose of hepatitis B vaccine.
- Prior hepatitis B vaccine must have been administered at age \<30 days.
- Major known congenital malformation or serious chronic disorder.
- Receipt of blood/plasma products or immunoglobulins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (48)
Mobile Pediatric Clinic
Mobile, Alabama, 36607, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432, United States
Emmaus Research Center, Inc.
Anaheim, California, 92804, United States
Hoag Memorial Hospital Presbyterian
Huntington Beach, California, 92648, United States
Madera Family Medical Group
Madera, California, 93637, United States
Orange County Research Institute
Ontario, California, 91762, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Center for Clinical Trials
Paramount, California, 90723, United States
Gentle Medicine Associates
Boynton Beach, Florida, 33435, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Next Phase Research Alliance
Homestead, Florida, 33030, United States
Acevedo Clinical Research Associates
Miami, Florida, 33142, United States
Bio-Medical Research, LLC
Miami, Florida, 33184, United States
Crystal Biomedical Research, LLC
Miami Lakes, Florida, 33014, United States
IACT Health
Columbus, Georgia, 31903, United States
Advocate Children's Hospital
Park Ridge, Illinois, 60068, United States
MOC Research
Mishawaka, Indiana, 46544, United States
Michael W. Simon, MD, PSC
Lexington, Kentucky, 40517, United States
All Children Pediatrics
Louisville, Kentucky, 40243, United States
Meridian Clinical Research, LLC
Baton Rouge, Louisiana, 70806, United States
MedPharmics, LLC
Metairie, Louisiana, 70006, United States
LSUHSC-Shreveport
Shreveport, Louisiana, 71103, United States
Ochsner-LSU Health Shreveport
Shreveport, Louisiana, 71103, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
Pediatric Phlebotomy
Boston, Massachusetts, 02111, United States
Tufts Medical Center IDS - Pharmacy
Boston, Massachusetts, 02111, United States
Children's Mercy Clinics on Broadway
Kansas City, Missouri, 64111, United States
Children's Physicians Embassy Park
Omaha, Nebraska, 68114, United States
Children's Physicians Spring Valley
Omaha, Nebraska, 68117, United States
Creighton University Clinical Research Office
Omaha, Nebraska, 68131, United States
Child Health care Associates
East Syracuse, New York, 13057, United States
Blue Ridge Pediatric and Adolescent Medicine, Inc
Boone, North Carolina, 28607, United States
Sugarcamp Family Research
Dayton, Ohio, 45409, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Parkside Pediatrics
Greenville, South Carolina, 29607, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, 57105, United States
Sanford Research
Sioux Falls, South Dakota, 57105, United States
Sanford 69th & Louise Family Medicine
Sioux Falls, South Dakota, 57108, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Ventavia Research Group
Houston, Texas, 77008, United States
Mercury Clinical Research
Houston, Texas, 77054, United States
Pediatric Associates
Houston, Texas, 77087, United States
Ventavia Research Group
Keller, Texas, 76248, United States
Tekton Research, Inc.
San Antonio, Texas, 78240, United States
Ventavia Research Group, LLC
Spring, Texas, 77389, United States
Dixie Pediatrics
St. George, Utah, 84790, United States
Marshall Health
Huntington, West Virginia, 25701, United States
Related Publications (1)
Simon MW, Bataille R, Caldwell NS, Gessner BD, Jodar L, Lamberth E, Peng Y, Scott DA, Lei L, Giardina PC, Gruber WC, Jansen KU, Thompson A, Watson W. Safety and immunogenicity of a multivalent pneumococcal conjugate vaccine given with 13-valent pneumococcal conjugate vaccine in healthy infants: A phase 2 randomized trial. Hum Vaccin Immunother. 2023 Aug;19(2):2245727. doi: 10.1080/21645515.2023.2245727. Epub 2023 Nov 5.
PMID: 37927075DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2018
First Posted
June 8, 2018
Study Start
June 1, 2018
Primary Completion
November 5, 2020
Study Completion
November 5, 2020
Last Updated
November 30, 2021
Results First Posted
November 30, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.