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New baby vaccine aims to beat pneumonia: VAX-31 trial underway

NCT ID NCT06720038

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new vaccine called VAX-31 to protect babies against pneumococcal disease, which can cause pneumonia and meningitis. About 900 healthy infants will receive four doses of VAX-31 or an existing vaccine starting at 2 months old. Researchers will check for side effects and measure how well the vaccine triggers the immune system.

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

900 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Dec 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 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. 2. Full-term infant at least 37 weeks gestational age at birth. 3. Afebrile for ≥72 hours with an tympanic or rectal temperature \<38.0°C (\<100.4°F) before receipt of study vaccine.\*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours. 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 tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination. 7. Subject's parent/legal guardian has an email 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 of hepatitis B vaccine). 3. Known hypersensitivity to any vaccine. 4. Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency). 5. Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a \<14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted. 6. History of failure to thrive or prior hospitalization for any chronic condition. 7. Subject has a bleeding disorder contraindicating IM vaccination. 8. Subject or his/her mother has documented hepatitis B surface antigen-positive test. 9. Subject has a known neurologic or cognitive behavioral disorder. 10. Subject 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 plans to receive another investigational product 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

  • AMR - Cottonwood

    Murray, Utah, 84107, United States

  • AMR - Layton

    Layton, Utah, 84041, United States

  • AMR - Roy

    Roy, Utah, 84067, United States

  • AMR - Syracuse

    Syracuse, Utah, 84075, United States

  • AMR South Jordan

    South Jordan, Utah, 84095, United States

  • Allegheny Health & Wellness Pavilion West

    Erie, Pennsylvania, 16506, United States

  • BRCR Global Puerto Rico

    San Juan, PR 907, Puerto Rico

  • Be Well Clinical Studies Nebraska

    Lincoln, Nebraska, 68516, United States

  • Caribbean Medical Research Center

    San Juan, PR 918, Puerto Rico

  • Center for Clinical Trials of San Gabriel

    West Covina, California, 91790, United States

  • Children's Hospital of Colorado - Dept. of Infectious Disease

    Aurora, Colorado, 80045, United States

  • Clinical Research Partners, LLC.

    Richmond, Virginia, 23226, United States

  • Clinical Research Prime - Rexburg

    Rexburg, Idaho, 83440, United States

  • Clinical Research Prime, LLP

    Idaho Falls, Idaho, 83404, United States

  • Complete Children's Health

    Lincoln, Nebraska, 68504, United States

  • Complete Children's Health

    Lincoln, Nebraska, 68505, United States

  • Complete Children's Health

    Lincoln, Nebraska, 68516, United States

  • Complete Children's Health

    Lincoln, Nebraska, 68522, United States

  • Cyn3rgy Research

    Gresham, Oregon, 97030, United States

  • Javara Inc. /Texas Health Care, PLLC

    Dallas, Texas, 75001-, United States

  • Kentucky Pediatrics/Adult Research

    Bardstown, Kentucky, 40004, United States

  • Kool Kids Pediatrics (Dynamed)

    Houston, Texas, 77065, United States

  • Matrix Clinical Research

    Gardena, California, 90237, United States

  • Matrix Clinical Research

    Los Angeles, California, 90057, United States

  • Mercury Clinical Research - Pediatric Associates

    Houston, Texas, 77087, United States

  • Oak Cliff Research Company

    Dallas, Texas, 75287, United States

  • Ohio Pediatric Research Association

    Dayton, Ohio, 45414, United States

  • Orange County Research Institute

    Ontario, California, 91762, United States

  • PAS Research

    Tampa, Florida, 33613, United States

  • Pediatric Center/Neutra Life Sciences

    Richmond, Texas, 77469, United States

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902, United States

  • Pediatric Research of Charlottesville, LLC

    Gordonsville, Virginia, 22942, United States

  • Ponce Medical School Foundation Inc. / CAIMED Center

    Ponce, PR 716, Puerto Rico

  • Proactive RGV LLC

    Brownsville, Texas, 78520, United States

  • SEC Clinical Research

    Pensacola, Florida, 32503, United States

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • Sunrise Pediatrics

    Houston, Texas, 77077, United States

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

    Jonesboro, Arkansas, 72401, United States

  • Tribe Clinical Research, LLC dba Neighbors Clinical Research

    Charleston, South Carolina, 29407, United States

  • Tribe Clinical Research/Parkside Pediatrics

    Simpsonville, South Carolina, 29680, United States

  • UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry

    Cranberry Township, Pennsylvania, 16066, United States

  • UPMC Children's Community Pediatrics - Norwin

    N. Huntingdon, Pennsylvania, 15642, 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

    Pittsburgh, Pennsylvania, 15025, United States

  • UPMC Children's Community Pediatrics-Castle Shannon

    Pittsburgh, Pennsylvania, 15234, United States

  • UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program

    League City, Texas, 77573, United States

More trials for these conditions

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