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New vaccine aims to outsmart pneumonia bacteria

NCT ID NCT07284654

Prevention 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study is testing a new vaccine called VAX-31 in about 4,000 healthy adults aged 50 and older. The goal is to see if VAX-31 provides better immune protection against more strains of pneumococcal bacteria compared to two current vaccines, Prevnar 20 and Capvaxive. Researchers are also checking safety and how well the vaccine works in younger adults aged 18-49.

What this could mean

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

Active substance
VAX-31 (31-valent pneumococcal conjugate vaccine)
What this could lead to
If successful, VAX-31 could provide broader protection against pneumococcal disease than current vaccines, potentially preventing more cases of pneumonia and other infections.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The vaccine may not prove superior or could cause side effects like pain or fever. Long-term safety and effectiveness are still unknown.

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

4,049 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Jan 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

18 years and older

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 ≥18 years of age (inclusive) at the time of randomization into the study. * Able and willing to complete the informed consent process. * Available for clinical follow-up through the last study visit. * In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator). * Willing to have blood samples collected and used for research purposes. * Able to provide proof of identity to the satisfaction of the site personnel completing the enrollment process. * Female participants of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method. * Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary). Exclusion Criteria: * History of invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age. * Previous receipt of any licensed or investigational pneumococcal vaccine at any age. * Receipt of any investigational product within 30 days prior to Day 1, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study. * Receipt of any live vaccine within 30 days prior to Day 1, or receipt of any non-live (including inactivated) vaccine within 14 days prior to Day 1. * Body temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescreened). * Current diagnosis of human immunodeficiency virus, Hepatitis B, or Hepatitis C. * History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination. * Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation. * Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency. * Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws. * Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to enrollment into the study. * Is currently receiving immunosuppressive or immune-modifying therapy, including systemic corticosteroids (this includes ≥3 months of prednisone equivalent from 5 to \<10 mg/day and ≥2 weeks of prednisone equivalent ≥10 mg/day). * Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent \>10 mg/day) within 14 days of study vaccination. * History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent. * Employee of, or first-degree relative of, any person employed by the Sponsor, the contract research organization (CRO), the Investigator, site personnel, or site.

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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

  • Accel Research Site - Achieve - Birmingham - ERN

    Birmingham, Alabama, 35216, United States

  • Advanced Memory Research Institute - CenExe

    Toms River, New Jersey, 08755, United States

  • Alliance for Multispecialty Research, LLC - Kansas City

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispecialty Research, LLC - West Wichita

    Wichita, Kansas, 67207, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Center for Indigenous Health - Chinle - Johns Hopkins Project

    Chinle, Arizona, 86503, United States

  • Center for Indigineous Health - Gallup - John Hopkins Project

    Gallup, New Mexico, 87301, United States

  • Center for Indigineous Health - Shiprock - John Hopkins Project

    Shiprock, New Mexico, 87420, United States

  • Center for Indigineous Health - Whiteriver - John Hopkins Project

    Whiteriver, Arizona, 85941, United States

  • Charlottesville Medical Research Center - Alcanza - HyperCore

    Charlottesville, Virginia, 22911, United States

  • Clinical Innovations Trials - Riverside - CenExel

    Riverside, California, 92506, United States

  • Clinical Research Atlanta - Headlands

    Stockbridge, Georgia, 30281, United States

  • Coastal Carolina Research Center - Alcanza - HyperCore

    North Charleston, South Carolina, 29405, United States

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • DM Clinical Research - Sugarland

    Sugar Land, Texas, 77478, United States

  • DelRicht Clinical Research, LLC - New Orleans

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research, LLC - Gulfport

    Gulfport, Mississippi, 39503, United States

  • Flourish Research - San Antonio

    San Antonio, Texas, 78229, United States

  • Headlands Research - Detroit - Headlands

    Southfield, Michigan, 48034, United States

  • Health Awareness - Jupiter - ERN

    Jupiter, Florida, 33458, United States

  • JBR Clinical Research - CenExel JBR

    Salt Lake City, Utah, 84107, United States

  • Johnson County Clin-Trials - JCCT

    Lenexa, Kansas, 66219, United States

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072, United States

  • Precision Clinical Research - Sunrise

    Sunrise, Florida, 33351, United States

  • Research Centers of America - Hollywood - CenExel

    Hollywood, Florida, 33024, United States

  • Rochester Clinical Research - ATLAS - Rochester

    Rochester, New York, 14609, United States

  • Sky Integrative Medical Center - SKYCRNG

    Ridgeland, Mississippi, 39157, United States

  • Suncoast Research Group LLC

    Miami, Florida, 33135, United States

  • Velocity Clinical Research

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research - Valparaiso (Buynak Clinical Research)

    Valparaiso, Indiana, 46383, United States

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