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New infant vaccine trial aims to shield against pneumonia and meningitis

NCT ID NCT07573462

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 16, 2026 · Updated 6 times

Summary

This study tests a new pneumococcal vaccine in about 2400 healthy infants starting at 2 months old. The goal is to see if the new vaccine is as safe as the current vaccine, Prevnar 20, and if it can protect against more types of bacteria that cause pneumonia, meningitis, and ear infections. Infants receive four doses over about a year and a half, and researchers track any side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2028

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: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bluewater Clinical Research Group Inc.

    RECRUITING

    Sarnia, Ontario, N7T 4X3, Canada

  • Boston Children's Health Physicians

    RECRUITING

    Hawthorne, New York, 10532, United States

  • Centre for Children's Health Research

    NOT_YET_RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Cyn3rgy Research Corporation

    RECRUITING

    Gresham, Oregon, 97030, United States

  • Donald Guthrie Foundation

    RECRUITING

    Sayre, Pennsylvania, 18840, United States

  • Dr. Gala, LLC

    NOT_YET_RECRUITING

    Miami, Florida, 33135, United States

  • Eagle Clinical Research

    RECRUITING

    Chicago, Illinois, 60621, United States

  • FVR, Espoon rokotetutkimusklinikka

    NOT_YET_RECRUITING

    Espoo, Uusimaa, 02230, Finland

  • FVR, Etelä-Helsingin rokotetutkimusklinikka

    NOT_YET_RECRUITING

    Helsinki, Uusimaa, 00100, Finland

  • FVR, Järvenpään rokotetutkimusklinikka

    NOT_YET_RECRUITING

    Jarvenpaa, Uusimaa, 04400, Finland

  • FVR, Kokkolan rokotetutkimusklinikka

    NOT_YET_RECRUITING

    Kokkola, Keski-Pohjanmaa, 67100, Finland

  • FVR, Oulun rokotetutkimusklinikka

    NOT_YET_RECRUITING

    Oulu, North Ostrobothnia, 90220, Finland

  • FVR, Tampereen rokotetutkimusklinikka

    NOT_YET_RECRUITING

    Tampere, Pirkanmaa, 33100, Finland

  • Guthrie Medical Group

    RECRUITING

    Sayre, Pennsylvania, 18840, United States

  • Innovate Research Centers, LLC

    RECRUITING

    Fort Lauderdale, Florida, 33304, United States

  • Kentucky Pediatric/ Adult Research

    RECRUITING

    Bardstown, Kentucky, 40004, United States

  • Kinder- und Jugendarztpraxis Dr. med. Michael Horn

    NOT_YET_RECRUITING

    Schönau am Königssee, Bavaria, 83471, Germany

  • LSU Health Shreveport Clinical Trials Office

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • Legacy Clinical Trials

    RECRUITING

    Oklahoma City, Oklahoma, 73103, United States

  • MacKoul Pediatrics Fort Myers

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • Maria Fareri Children's Hospital

    RECRUITING

    Valhalla, New York, 10595, United States

  • MeVac - Meilahti Vaccine Research Center

    NOT_YET_RECRUITING

    Helsinki, Uusimaa, 00290, Finland

  • Milestone Research Inc.

    RECRUITING

    London, Ontario, N5W 6A2, Canada

  • Monash Health

    NOT_YET_RECRUITING

    Clayton, Victoria, 3168, Australia

  • Murdoch Children's Research Institute

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • National Research Centers, Plano LLC

    NOT_YET_RECRUITING

    Plano, Texas, 75093, United States

  • Ochsner LSU Health Shreveport Ambulatory Care Center

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Ochsner/LSU Health Shreveport - Progressive Pediatrics

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • Ochsner/LSU Health Shreveport Academic Medical Center

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Pediatric Associates of Fall River

    RECRUITING

    Fall River, Massachusetts, 02721, United States

  • Pediatric Research of Charlottesville, LLC.

    RECRUITING

    Gordonsville, Virginia, 22942, United States

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Queensland Children's Hospital

    NOT_YET_RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    RECRUITING

    Union City, Georgia, 30291, United States

  • Rosemark Women Care Specialists

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym

    NOT_YET_RECRUITING

    Dziekanów Leśny, 05-092, Poland

  • Senders Pediatrics

    RECRUITING

    South Euclid, Ohio, 44121, United States

  • Starz Pediatrics

    RECRUITING

    Estero, Florida, 33928, United States

  • The Children's Hospital at Westmead

    NOT_YET_RECRUITING

    Westmead, New South Wales, 2145, Australia

  • The Kids Research Institute Australia

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks

    RECRUITING

    Simpsonville, South Carolina, 29680, United States

More trials for these conditions

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