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Clinical Trials in the USA / NCT07573462
Recruiting Phase 3

A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

NCT07573462 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-05-04
Last updated
2026-10-26

Condition(s) studied

Pneumococcal Disease

Investigational drug(s) / intervention(s)

PG4 →20-valent pneumococcal conjugate vaccine (20vPnC) →

PG4: Multivalent Pneumococcal Vaccine

20-valent pneumococcal conjugate vaccine (20vPnC): 20-valent pneumococcal conjugate vaccine (20vPnC)

Study 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 that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae.

There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are:

\- infants who are about 2 months of age

About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age.

Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.

Eligibility

Sex
ALL
Min age
42 Days
Max age
98 Days
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Percentage of participants reporting local reactions within 7 days after each dose — Day 7
    Prompted local reactions after each dose
  • Percentage of participants reporting systemic events within 7 days after each dose — Day 7
    Prompted systemic events after each dose
  • Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 — Dose 1 to 1 month after Dose 3
    AEs occurring from Dose 1 to 1 month after Dose 3
  • Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 — Dose 4 to 1 month after Dose 4
    AEs occurring from Dose 4 to 1 month after Dose 4
  • Percentage of participants reporting serious adverse events (SAEs) — Dose 1 to 6 months after Dose 4
    SAEs occurring from Dose 1 to 6 months after Dose 4

Trial sites (78)

FacilityCityRegionStatus
Starz Pediatrics Estero Florida Recruiting
Innovate Research Centers, LLC Fort Lauderdale Florida Recruiting
MacKoul Pediatrics Fort Myers Fort Myers Florida Recruiting
Speranza Research Center Hialeah Florida Recruiting
Dr. Gala, LLC Miami Florida Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia Recruiting
Rosemark Women Care Specialists Idaho Falls Idaho Recruiting
Eagle Clinical Research Chicago Illinois Recruiting
Kentucky Pediatric/ Adult Research Bardstown Kentucky Recruiting
LSU Health Shreveport Clinical Trials Office Shreveport Louisiana Recruiting
Ochsner LSU Health - Progressive Pediatrics Shreveport Louisiana Recruiting
Ochsner LSU Health Shreveport Academic Medical Center Shreveport Louisiana Recruiting
Ochsner LSU Health Shreveport Ambulatory Care Center Shreveport Louisiana Recruiting
Pediatric Associates of Fall River Fall River Massachusetts Recruiting
Lincoln Pediatric Group Lincoln Nebraska Recruiting
Boston Children's Health Physicians Hawthorne New York Recruiting
Maria Fareri Children's Hospital Valhalla New York Recruiting
Senders Pediatrics South Euclid Ohio Recruiting
Legacy Clinical Trials Oklahoma City Oklahoma Recruiting
Cyn3rgy Research Corporation Gresham Oregon Recruiting
Donald Guthrie Foundation Sayre Pennsylvania Recruiting
Guthrie Medical Group Sayre Pennsylvania Recruiting
Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks Simpsonville South Carolina Recruiting
National Research Centers, Plano LLC Plano Texas Recruiting
Pediatric Research of Charlottesville, LLC. Gordonsville Virginia Recruiting
Instituto Médico Río Cuarto Río Cuarto Córdoba Province Not Yet Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L San Miguel de Tucumán Tucumán Province Not Yet Recruiting
Hospital del Niño Jesus San Miguel de Tucumán Tucumán Province Not Yet Recruiting
The Children's Hospital at Westmead Westmead New South Wales Recruiting
Queensland Children's Hospital Brisbane Queensland Recruiting
Centre for Children's Health Research South Brisbane Queensland Recruiting
Monash Health Clayton Victoria Recruiting
Murdoch Children's Research Institute Parkville Victoria Recruiting
Perth Children's Hospital Nedlands Western Australia Recruiting
The Kids Research Institute Australia Nedlands Western Australia Recruiting
Milestone Research Inc. London Ontario Recruiting
Bluewater Clinical Research Group Inc. Sarnia Ontario Recruiting
CHU Sainte-Justine Montreal Quebec Not Yet Recruiting
McGill University Health Centre - Vaccine Study Centre Pierrefonds-Roxboro Quebec Not Yet Recruiting
FVR, Kokkolan rokotetutkimusklinikka Kokkola Keski-Pohjanmaa Recruiting

+ 38 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults Recruiting
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents Recruiting
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants. Recruiting
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07573462 on ClinicalTrials.gov ↗ ← All trials in the USA