Actively Recruiting
A Phase 3, Randomized, Double-Blinded Trial to Evaluate the Safety and Tolerability of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
Led by Pfizer · Updated on 2026-05-27
2400
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a new pneumococcal vaccine called PG4 in healthy infants around 2 months old. This vaccine aims to provide protection against infections caused by Streptococcus pneumoniae, including pneumonia, meningitis, and ear infections. The study compares PG4 to the currently used 20-valent pneumococcal conjugate vaccine (20vPnC) to see if the new vaccine is as safe and possibly offers broader protection. About 2400 infants will be randomly assigned to receive either the new vaccine PG4 or the 20vPnC vaccine. Each infant will get four doses injected into the left thigh muscle at ages 2, 4, 6, and between 12 to 15 months. The study lasts about 16 to 19 months for each participant and includes six clinic visits and one phone call. During the visits, parents or guardians will be asked about any side effects their infant may experience, such as local reactions or systemic events within seven days after each dose. The researchers will monitor adverse events from the first dose through six months after the last dose. The study aims to measure and compare the safety and tolerability of both vaccines over this period.
CONDITIONS
Brief Title
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants who are about 2 months of age
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Dose 1 to 1 month after Dose 4
Participants receive intramuscular doses of a multivalent pneumococcal vaccine or a 20-valent pneumococcal conjugate vaccine.
4 vaccination visits and 4 follow-up visits within 1 month after each dose
Duration - Up to 6 months after Dose 4
Participants are monitored for any serious adverse events up to 6 months after the last dose.
Periodic visits during the 6-month follow-up period
Trial Site Locations
Total: 9 locations
1
Starz Pediatrics
Estero, Florida, United States, 33928
Not Yet Recruiting
2
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States, 30291
Not Yet Recruiting
3
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States, 83404
Not Yet Recruiting
4
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States, 40004
Not Yet Recruiting
5
Pediatric Associates of Fall River
Fall River, Massachusetts, United States, 02721
Not Yet Recruiting
6
Senders Pediatrics
South Euclid, Ohio, United States, 44121
Actively Recruiting
7
Cyn3rgy Research Corporation
Gresham, Oregon, United States, 97030
Not Yet Recruiting
8
Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
Simpsonville, South Carolina, United States, 29680
Actively Recruiting
9
Pediatric Research of Charlottesville, LLC.
Gordonsville, Virginia, United States, 22942
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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