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New 24-Strain pneumonia vaccine shows promise in infant trial

NCT ID NCT05844423

Vaccine Sponsor: Vaxcyte, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new vaccine called VAX-24, which targets 24 types of pneumococcal bacteria, in 802 healthy infants. The babies received four doses at 2, 4, 6, and 12-15 months old, alongside routine vaccines. The goal was to check safety and how well the vaccine triggers an immune response compared to current vaccines that cover fewer strains.

What this could mean

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

Active substance
24-valent pneumococcal conjugate vaccine (VAX-24)
What this could lead to
If successful, this vaccine could protect infants against more strains of pneumococcal bacteria than current vaccines, potentially preventing more cases of pneumonia, meningitis, and ear infections.
What could go wrong
This is a phase 2 dose-finding study, so it is still early. The vaccine may not prove more effective or as safe as existing vaccines, and side effects like injection-site reactions or fever are possible.

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

802 people

The number who actually took part.

Started

Mar 2023

Finished

Aug 2025

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 89 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: 1. Healthy male or female infant ≥42 days to ≤89 days (inclusive). 2. Full-term infant at least 37 weeks gestational age at birth. 3. Afebrile for ≥72 hours with a rectal temperature \<38.0°C (\<100.4°F) or axillary temperature \<37.8°C (\<100.0°F) before receipt of study vaccine.\* 4. Able to attend all scheduled visits and comply with the study procedures. 5. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent. 6. Subject's parent/legal guardian is able to fill out an ediary of solicited AE and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination. 7. Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary. Exclusion Criteria: 1. History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. 2. Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine). 3. Known hypersensitivity to any vaccine. 4. Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency). 5. Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). 6. History of failure to thrive. 7. Subject has a coagulation disorder contraindicating IM vaccination. 8. Subject or his/her mother have documented hepatitis B surface antigen-positive. 9. Has a known neurologic or cognitive behavioral disorder. 10. Has a known clinically significant congenital malformation or serious chronic disorder. 11. Receipt of a blood transfusion or blood products, including immunoglobulins. 12. Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study. 13. Any infant who cannot be adequately followed for safety according to the protocol plan. 14. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

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Conditions

The condition(s) this trial relates to.

pneumonia pneumococcal infection prevention target

As listed by the trial registrant

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

Pneumococcal vaccines

Contacts and locations

Locations

  • ACC Pediatric Research

    Haughton, Louisiana, 71037, United States

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506, United States

  • Alliance for Multispecialty Research

    Layton, Utah, 84041, United States

  • Alliance for Multispecialty Research

    Murray, Utah, 84107, United States

  • Alliance for Multispecialty Research

    Provo, Utah, 84604, United States

  • Alliance for Multispecialty Research

    Roy, Utah, 84067, United States

  • Alliance for Multispecialty Research

    Syracuse, Utah, 84075, United States

  • Coastal Pediatric Research

    Summerville, South Carolina, 29486, United States

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Jedidiah Clinical Research

    Tampa, Florida, 33617, United States

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • Kool Kids Pediatrics

    Houston, Texas, 77065, United States

  • Madera Family Medical Group

    Madera, California, 93637, United States

  • Meridian Clinical Research

    Hastings, Nebraska, 68901, United States

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68504, United States

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68505, United States

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68516, United States

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68522, United States

  • Ohio Pediatric Research Assn.

    Dayton, Ohio, 45414, United States

  • Palmetto Pediatrics, PA

    North Charleston, South Carolina, 29406, United States

  • Pediatric Associates

    Houston, Texas, 77087, United States

  • Pediatric Center

    Richmond, Texas, 77469, United States

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902, United States

  • The Children's Clinic of Jonesboro, P.A.

    Jonesboro, Arkansas, 72401, United States

  • Tribe Clinical Research at Parkside Pediatrics

    Simpsonville, South Carolina, 29680, United States

  • UPMC Bass Wolfson Cranberry

    Cranberry Township, Pennsylvania, 16066, United States

  • UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill

    Pittsburgh, Pennsylvania, 15217, United States

  • UPMC Children's Community Pediatrics South Hills-Jefferson Hills

    Jefferson Hills, Pennsylvania, 15025, United States

  • UPMC Children's Community Pediatrics-Castle Shannon

    Pittsburgh, Pennsylvania, 15234, United States

  • UPMC Primary Care Center Oakland

    Pittsburgh, Pennsylvania, 15213, United States

  • Ventavia

    Houston, Texas, 77008, United States

  • Ventavia Research Group

    Burleson, Texas, 76028, United States

More trials for these conditions

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