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New combo shot study: could VAX-31 plus flu vaccine be a Game-Changer for seniors?

NCT ID NCT07365826

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests a new vaccine called VAX-31, which protects against 31 types of pneumonia-causing bacteria. It is given together with the seasonal flu shot to healthy adults aged 50 and older. The goal is to see if giving both vaccines at the same time is safe and works as well as getting them separately. About 1,390 participants will be followed for 7 months.

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

1,390 people

The number who actually took part.

Started

Jan 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: 1. Male or female ≥50 years of age (inclusive) at the time of randomization into the study. 2. Able and willing to complete the informed consent process. 3. Available for clinical follow-up through the last study visit at 7 months after the first study vaccination. 4. 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. 5. Willing to have blood samples collected and used for research purposes. 6. Able to provide proof of identity to the satisfaction of the study site personnel completing the enrollment process. 7. Female subjects of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test at Screening and immediately prior to each vaccination and agree to use acceptable contraception, if heterosexually active. Female subjects who are not abstinent from heterosexual intercourse must agree to consistently practice contraception at least 7 days prior to vaccination and through their last study visit. Male subjects with partners of childbearing potential must agree to practice an acceptable contraception method (\[use condoms with or without spermicide\] or have undergone a vasectomy) from Day 1 through their last study visit. Note: A history of amenorrhea for at least 12 months without an alternative medical cause is required for a female to be considered postmenopausal in the study. 8. Able to access and use a device connected to Wi-Fi or cellular network for completion of an electronic diary (eDiary). Exclusion Criteria: 1. History of IPD or pneumococcal pneumonia (either confirmed or self-reported) at any age. 2. Previous receipt of a licensed or investigational pneumococcal vaccine at any age. 3. Previous receipt of an influenza vaccine from the current season; receipt of any influenza vaccine (licensed or investigational) within 6 months prior to Day 1; or receipt/planned receipt of any licensed or investigational non-study influenza vaccine during study participation. 4. 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. 5. Planned or actual administration of any licensed vaccine within 30 days prior to Day 1. 6. Body temperature \>38.0°C (\>100.4°F) or acute illness within 3 days prior to study vaccination (participant may be rescreened). 7. Current diagnosis of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C. 8. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination. 9. History of Guillain-Barré syndrome. 10. Individual who is pregnant, breastfeeding, or planning to become pregnant during study participation. 11. Has a known or suspected immunocompromising condition, including, but not limited to, leukemia, lymphoma, chronic renal failure, or congenital or acquired immunodeficiency. 12. 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. 13. Receipt of blood or blood product (including polyclonal intravenous immunoglobulin) within 60 days prior to Day 1. 14. Receiving immunosuppressive therapy. 15. Received any part of a ≥14-day course of systemic corticosteroids (prednisone equivalent \>10 mg/day) within 14 days of study vaccinations. Note: Receipt of a ≥14-day course of systemic corticosteroids equivalent to ≤10 mg/day is permitted, as are inhaled, nebulized, topical, intra-articular, and intrabursal corticosteroids. 16. History of malignancy ≤5 years before to Day 1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 17. Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a participant's ability to give informed consent. 18. Employee of, or first-degree relative of any person employed by the Sponsor, the contract research organization (CRO), the Investigator, study 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 Knxoville

    Knoxville, Tennessee, 37909, United States

  • AMR Lexington

    Lexington, Kentucky, 40509, United States

  • Accel Research Sites - Lakeland

    Lakeland, Florida, 33803, United States

  • Accel Research Sites - Largo

    Largo, Florida, 33777, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • CenExel JBR Clinical Research

    Salt Lake City, Utah, 84107, United States

  • CenExel Research Centers of America

    Hollywood, Florida, 33024, United States

  • Charlottesville Medical Research Center

    Charlottesville, Virginia, 22911, United States

  • Clinical Research Partners, LLC.

    Richmond, Virginia, 23226, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • DM Clinical Research - Detroit

    Detroit, Michigan, 48076, United States

  • DelRicht Research - Hendersonville

    Hendersonville, Tennessee, 37075, United States

  • Epic Medical Research

    DeSoto, Texas, 75115, United States

  • Health Awareness

    Jupiter, Florida, 33458, United States

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606, United States

  • Hope Research Institute

    Phoenix, Arizona, 85032, United States

  • Johnson County ClinTrials

    Lenexa, Kansas, 66219, United States

  • Precision Clinical Research

    Sunrise, Florida, 33351, United States

  • REX Clinical Trials

    Beaumont, Texas, 77701, United States

  • Rochester Clinical Research

    Rochester, New York, 14609, United States

  • Tekton Research at Austin

    Austin, Texas, 78745, United States

  • Tekton Research at Fort Collins

    Fort Collins, Colorado, 80525, United States

  • University Clinical Research - Deland

    DeLand, Florida, 32720-0834, United States

  • Velocity Omaha

    Omaha, Nebraska, 68134, United States

  • Velocity Valparaiso

    Valparaiso, Indiana, 46383, United States

More trials for these conditions

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