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VAX-31 vaccine for adults 50+ who previously received a pneumococcal vaccine

A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Prior Pneumococcal Vaccination

Phase 3 Interventional Vaxcyte, Inc. · NCT07425392

This trial will test whether the VAX-31 vaccine is safe, tolerable, and triggers immune responses in adults aged 50 and older who previously received a pneumococcal vaccine.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment720 (estimated)
Ages50 Years and up
SexAll
SponsorVaxcyte, Inc. Industry-sponsored
Drugs / interventionsprednisone
Locations30 sites (Chinle, Arizona and 29 other locations)
Trial IDNCT07425392 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial enrolls adults aged 50 years and older who have previously received a licensed pneumococcal vaccine. Participants will receive the 31-valent pneumococcal conjugate vaccine (VAX-31) or a comparator (PCV20) and will be monitored for safety, tolerability, and antibody responses with blood draws at scheduled visits. Eligibility requires prior pneumococcal vaccination at least 1 year earlier (or ≥6 months for PCV21) and generally stable health. The study is sponsored by Vaxcyte and conducted at community and Indigenous health centers in Arizona.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 or older who previously received a licensed pneumococcal vaccine, are in stable health, and are willing to provide blood samples and attend follow-up visits.

Not a fit: People under 50, those who received a recent pneumococcal vaccine within the study's exclusion window, or those with unstable medical conditions are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, VAX-31 could provide broader protection against more pneumococcal strains for older adults.

How similar studies have performed: Higher-valent conjugate vaccines such as PCV20 have shown safety and immunogenicity, so this approach builds on prior successes though a 31-valent formulation is newer and less tested at large scale.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Chinle, Arizona and 29 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pneumococcal VaccinesPneumoniaPneumococcal Infection31-Valent PCV
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.