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New pneumonia vaccine VAX-31 aims to boost protection in older adults

NCT ID NCT07425392

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study tests a new vaccine called VAX-31 in adults aged 50 and older who have already received a pneumonia vaccine. The goal is to see if VAX-31 is safe and triggers a strong immune response. About 752 participants will receive either VAX-31 or an active comparator vaccine, and researchers will monitor side effects and antibody levels.

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

752 people

The number who actually took part.

Started

Feb 2026

Expected to finish

Mar 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

50 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 ≥50 years of age (inclusive) at the time of randomization into the study. * Previous receipt of a licensed pneumococcal vaccine or combination of licensed vaccines, with most recent vaccination ≥1 year prior to randomization; the exception is PCV21, which may have been received ≥6 months prior to randomization (confirmed). * 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: * Previous invasive pneumococcal disease (IPD) or pneumococcal pneumonia (either confirmed or self-reported) at any age. * Previous receipt of an 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

  • AMR

    Kansas City, Missouri, 64114, United States

  • Alcanza (Charlottesville Medical Research)

    Charlottesville, Virginia, 22911, United States

  • Avacare (CCT Research)

    Phoenix, Arizona, 85044, United States

  • CenExel (RCA)

    Hollywood, Florida, 33024, United States

  • Center of American Indian Health

    Gallup, New Mexico, 87301, United States

  • Chase Medical Research

    Waterbury, Connecticut, 06708, United States

  • Chinle Center for Indigenous Health

    Chinle, Arizona, 86503, United States

  • DM Clinical Research

    Sugar Land, Texas, 77478, United States

  • DM Clinical Research-Detroit

    Southfield, Michigan, 48076, United States

  • DelRicht Clinical Research

    Stockbridge, Georgia, 30281, United States

  • DelRicht Clinical Research

    New Orleans, Louisiana, 70115, United States

  • DelRicht Research

    Hendersonville, Tennessee, 37075, United States

  • DelRicht Research (Command Family Medicine)

    Springfield, Missouri, 65807, United States

  • Eximia (Health Awareness)

    Jupiter, Florida, 33458, United States

  • Eximia (Health Awareness)

    Port Saint Lucie, Florida, 34952, United States

  • Flourish Research

    San Antonio, Texas, 78229, United States

  • Headlands (Trial Management Associates)

    Wilmington, North Carolina, 28403, United States

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606, United States

  • Johnson County Clin-Trials, LLC

    Lenexa, Kansas, 66219, United States

  • Precision Clinical Research

    Sunrise, Florida, 33351, United States

  • Quality Clinical Research

    Omaha, Nebraska, 68114, United States

  • REX Clinical Trials

    Beaumont, Texas, 77701, United States

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609, United States

  • Shiprock Center for Indigenous Health

    Shiprock, New Mexico, 87420, United States

  • Tekton Research

    Edmond, Oklahoma, 73013, United States

  • Tekton Research

    Austin, Texas, 78745, United States

  • The Villages

    The Villages, Florida, 32162, United States

  • Velocity (Meridian Clinical Research)

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Valparaiso

    Valparaiso, Indiana, 46383, United States

  • Whiteriver Center for Indigenous Health

    Whiteriver, Arizona, 85941, United States

More trials for these conditions

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