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New vaccine for infants aims to fight pneumococcal disease

NCT ID NCT06524414

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This phase 2 trial is testing a new pneumococcal vaccine (PG4) in about 605 healthy infants to see if it is safe and triggers a strong immune response. Infants will receive four doses starting at 2 months old, and the new vaccine will be compared to existing vaccines like Prevnar 20. The study will monitor side effects and measure antibody levels in the blood to gauge protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
multivalent pneumococcal conjugate vaccine (PG4)
What this could lead to
If successful, this could lead to a new vaccine that protects infants against pneumococcal disease, potentially offering broader or improved protection compared to current vaccines.
What could go wrong
This is an early phase 2 trial with 605 infants, so results may not confirm effectiveness or safety in larger populations. Side effects like local reactions or fever are possible, and the new vaccine may not prove better than existing ones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

605 people

The number who actually took part.

Started

Jul 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

42 to 98 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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.

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Conditions

The condition(s) this trial relates to.

pneumococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumococcal disease

Contacts and locations

Locations

  • AMR Clinical

    Kaysville, Utah, 84037, 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

  • All Children Pediatrics

    Louisville, Kentucky, 40243, United States

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506, United States

  • Alliance for Multispecialty Research, LLC

    Layton, Utah, 84041, United States

  • BRCR Global Puerto Rico

    San Juan, 00907-1509, Puerto Rico

  • Blue Moose Pediatrics

    Missoula, Montana, 59804, United States

  • Bluegrass Clinical Research, Inc.

    Louisville, Kentucky, 40291, United States

  • Boeson Research GTF

    Great Falls, Montana, 59405, United States

  • Boeson Research KAL

    Kalispell, Montana, 59901, United States

  • Boeson Research Laboratory

    Missoula, Montana, 59804, United States

  • Boeson Research MSO

    Missoula, Montana, 59804, United States

  • CMRC Headlands, LLC

    San Juan, 00918, Puerto Rico

  • Child Health Care Associates

    East Syracuse, New York, 13057, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Clinical Research Puerto Rico

    Guayama, 00784, Puerto Rico

  • Coastal Pediatric Research

    Summerville, South Carolina, 29486, United States

  • Cotton O'Neil Pediatrics

    Topeka, Kansas, 66604, United States

  • Cyn3rgy Research

    Gresham, Oregon, 97030, United States

  • DCOL Center for Clinical Research

    Longview, Texas, 75605, United States

  • Dayton Clinical Research

    Dayton, Ohio, 45409, 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

  • Heart and Hands Midwifery and Family Practice

    Kalispell, Montana, 59901, United States

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Javara - Privia Medical Group North Texas - Dallas

    Dallas, Texas, 75230, United States

  • Javara Inc a Delaware corporation

    Winston-Salem, North Carolina, 27101, United States

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • LSUHSC Clinical Trials Office

    Shreveport, Louisiana, 71101, 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

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana, 71103, United States

  • Mercury Clinical Research - Pediatric Associates

    Houston, Texas, 77087, United States

  • Mercury clinical research Inc.

    Houston, Texas, 77054, United States

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68522, United States

  • Northwest Arkansas Pediatric Clinic

    Fayetteville, Arkansas, 72703, United States

  • OBGYN Associates

    Great Falls, Montana, 59405, United States

  • Oak Cliff Research Company, LLC

    Dallas, Texas, 75287, United States

  • Ochsner/LSU Health Ambulatory Care Center

    Shreveport, Louisiana, 71103, United States

  • Ohio Pediatric Research Assn.

    Dayton, Ohio, 45414, United States

  • Origin Health

    Great Falls, Montana, 59405, United States

  • PAS Research - McAllen

    Edinburg, Texas, 78539, United States

  • POEM Healthcare

    Kalispell, Montana, 59901, United States

  • Pediatric Associates of Fall River

    Fall River, Massachusetts, 02721, United States

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902, United States

  • Ponce Medical School Foundation Inc.

    Ponce, 00716, Puerto Rico

  • Riveldi Biomedical Research and Associates - Miami

    Miami Lakes, Florida, 33014, United States

  • San Miguel Medical

    Trujillo Alto, PR, 00976, Puerto Rico

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • Square-1 Clincal Research

    Erie, Pennsylvania, 16506, United States

  • Tanner Clinic

    Layton, Utah, 84041, United States

  • Tanner Clinic - Kaysville

    Kaysville, Utah, 84037, United States

  • Tanner Memorial Clinic

    Layton, Utah, 84041, United States

  • The Children's Clinic

    Jonesboro, Arkansas, 72401, United States

  • The Hispanic Alliance for Clinical and Translational Research

    San Juan, 00935, Puerto Rico

  • The Iowa Clinic

    Ankeny, Iowa, 50023, United States

  • UMB/CVD

    Frederick, Maryland, 21702, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Puerto Rico - Medical Sciences Campus

    San Juan, 00935-6528, Puerto Rico

  • University of Rochester

    Rochester, New York, 14611, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Texas Medical Branch

    League City, Texas, 77573, United States

  • Velocity Clinical Research Inc.

    Durham, North Carolina, 27701, United States

  • Velocity Clinical Research, Washington DC

    Washington D.C., District of Columbia, 20016, United States

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Other studies related to the condition(s) this trial covers.