A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
3 other identifiers
interventional
605
2 countries
67
Brief Summary
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine. To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution. The immune response is how the body's cells; tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. This study is seeking participants who are:
- male or female infants who are 2 months of age,
- infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and,
- said to be healthy by the study doctor There are four groups in this study. All participants will be assigned to one of the four groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study. The first 400 participants who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Groups 1 and 2 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. The main difference between Groups 1 and 2 is that participants in Group 2 will have the first blood sample collected at an earlier time than those in Group 1. Once 400 participants have been assigned to Groups 1 and 2 then 100 new participants will be assigned to Group 3. Half the participants in Group 3 will receive PG4 in the second solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Groups 3 will receive 4 doses of 20vPnC (Prevnar 20®) at 2, 4, 6, and 12 to 15 months of age. Once the 100 participants have been assigned to Group 3 then 300 new participants will be assigned to Group 4. Half the participants in Group 4 will receive PG4 in the first solution at 2, 4, 6, and 12 to 15 months of age. The other half of the participants in Group 4 will receive 4 doses of a licensed pneumococcal comparator vaccine at 2, 4, 6, and 12 to 15 months of age. Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
Typical duration for phase_2
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2024
CompletedStudy Start
First participant enrolled
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 28, 2026
April 1, 2026
2.8 years
July 23, 2024
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Percentage of participants reporting local reactions within 7 days after each dose
Prompted local reactions after each dose
Day 7
Percentage of participants reporting systemic events within 7 days after each dose
Prompted systemic reactions after each dose
Day 7
Percentage of participants reporting adverse events (AEs)
AEs occurring from Dose 1 to 1 month after Dose 2
Dose 1 to 1 month after Dose 3
Percentage of participants reporting AEs
AEs occurring from Dose 4 to 1 month after Dose 4
Dose 4 to 1 month after Dose 4
Percentage of participants reporting serious adverse events (SAEs)
SAEs occurring from Dose 1 to 6 months after Dose 4
Dose 1 to 6 months after Dose 4
Secondary Outcomes (1)
Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs)
1 month after Dose 4
Study Arms (8)
Group 1 PG4
EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)
ACTIVE COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 2 PG4
EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)
ACTIVE COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 3 PG4
EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 3 20-valent pneumococcal conjugate vaccine (20vPnC)
ACTIVE COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 4 PG4
EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 4 15-valent pneumococcal conjugate vaccine (PCV15)
ACTIVE COMPARATOR15-valent pneumococcal conjugate vaccine (PCV15)
Interventions
20-valent pneumococcal conjugate vaccine
15-valent pneumococcal conjugate vaccine
Eligibility Criteria
You may qualify if:
- Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
You may not qualify if:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
- Major known congenital malformation or serious chronic disorder.
- Other acute or chronic medical or psychiatric condition 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.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (67)
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703, United States
The Children's Clinic
Jonesboro, Arkansas, 72401, United States
Los Ninos Children's Medical Clinic
La Puente, California, 91744, United States
Los Ninos Children's Medical Clinic
West Covina, California, 91790, United States
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, 20016, United States
Riveldi Biomedical Research and Associates - Miami
Miami Lakes, Florida, 33014, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
The Iowa Clinic
Ankeny, Iowa, 50023, United States
Cotton O'Neil Pediatrics
Topeka, Kansas, 66604, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004, United States
All Children Pediatrics
Louisville, Kentucky, 40243, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291, United States
LSUHSC Clinical Trials Office
Shreveport, Louisiana, 71101, United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71103, United States
Ochsner/LSU Health Ambulatory Care Center
Shreveport, Louisiana, 71103, United States
University of Maryland
Baltimore, Maryland, 21201, United States
UMB/CVD
Frederick, Maryland, 21702, United States
Pediatric Associates of Fall River
Fall River, Massachusetts, 02721, United States
Boeson Research GTF
Great Falls, Montana, 59405, United States
OBGYN Associates
Great Falls, Montana, 59405, United States
Heart and Hands Midwifery and Family Practice
Kalispell, Montana, 59901, United States
POEM Healthcare
Kalispell, Montana, 59901, United States
Boeson Research KAL
Missoula, Montana, 59804, United States
Boeson Research Laboratory
Missoula, Montana, 59804, United States
Boeson Research MSO
Missoula, Montana, 59804, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68522, United States
Child Health Care Associates
East Syracuse, New York, 13057, United States
University of Rochester
Rochester, New York, 14611, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Velocity Clinical Research Inc.
Durham, North Carolina, 27701, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
Durham Pediatrics at North Duke Street
Durham, North Carolina, 27704, United States
Javara Inc a Delaware corporation
Winston-Salem, North Carolina, 27101, United States
Dayton Clinical Research
Dayton, Ohio, 45409, United States
Ohio Pediatric Research Assn.
Dayton, Ohio, 45414, United States
Senders Pediatrics
South Euclid, Ohio, 44121, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506, United States
Square-1 Clincal Research
Erie, Pennsylvania, 16506, United States
Coastal Pediatric Research
Summerville, South Carolina, 29486, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Oak Cliff Research Company, LLC
Dallas, Texas, 75208, United States
Javara - Privia Medical Group North Texas - Dallas
Dallas, Texas, 75230, United States
Oak Cliff Research Company, LLC
Dallas, Texas, 75252, United States
PAS Research - McAllen
Edinburg, Texas, 78539, United States
Mercury clinical research Inc.
Houston, Texas, 77054, United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, 77087, United States
University of Texas Medical Branch
League City, Texas, 77573, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
AMR Clinical
Kaysville, Utah, 84037, United States
Tanner Clinic - Kaysville
Kaysville, Utah, 84037, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041, United States
Tanner Clinic
Layton, Utah, 84041, United States
Tanner Memorial Clinic
Layton, Utah, 84041, United States
AMR Clinical
Murray, Utah, 84107, United States
AMR Clinical
Provo, Utah, 84604, United States
AMR Clinical
Roy, Utah, 84067, United States
AMR Clinical
South Jordan, Utah, 84095, United States
AMR Clinical
Syracuse, Utah, 84075, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902, United States
San Miguel Medical
Trujillo Alto, PR, 00976, Puerto Rico
Clinical Research Puerto Rico
Guayama, 00784, Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
BRCR Global Puerto Rico
San Juan, 00907-1509, Puerto Rico
CMRC Headlands, LLC
San Juan, 00918, Puerto Rico
University of Puerto Rico - Medical Sciences Campus
San Juan, 00935-6528, Puerto Rico
The Hispanic Alliance for Clinical and Translational Research
San Juan, 00935, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2024
First Posted
July 29, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
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.