A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age

NCT07365826
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,390
clinicaltrials.gov
Lead sponsor
Vaxcyte, Inc.
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Start date
2026-01-12
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Number of sites
25
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Summary
This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.
clinicaltrials.gov
Short title
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 Concomitantly Administered With Seasonal Influenza Vaccine in Healthy Subjects 50 Years of Age and Older
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-03-01
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First posted
2026-01-26
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Registry last updated
2026-06-30
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Primary completion date
2027-03-01
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Start date
2026-01-12
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Actual participants
1,390
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Participants
1,390
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
1
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Number of sites
25
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Vaxcyte, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07365826
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ClinicalTrials.gov ID
NCT07365826
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of opsonophagocytic activity (OPA) geometric mean titers (GMT) in evaluable participants

    Timeframe: 1 Month after VAX-31 vaccination

  2. For each of the strains in SIV, the ratio (co-administration group to sequential administration group) of hemagglutination inhibition (HAI) GMT in evaluable participants

    Timeframe: 1 Month after SIV administration

  3. Percentage of participants reporting solicited local adverse events (AE) within 7 days after Day 1 and Month 1 vaccination (redness, swelling, and pain at injection site) in each group

    Timeframe: 7 days after each vaccination

  4. Percentage of participants reporting solicited systemic AE within 7 days after Day 1 and Month 1 vaccination (fever, headache, fatigue, muscle pain, and joint pain) in each group

    Timeframe: 7 days after each vaccination

  5. Percentage of participants reporting unsolicited AE within 1 month after Day 1 and Month 1 vaccination in each group

    Timeframe: 7 days after each vaccination

  6. Percentage of participants reporting NOCI, MAAE, and SAE within 6 months after last vaccination in each group

    Timeframe: 6 Months after last vaccination

  1. For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of IgG geometric mean concentrations (GMC) in evaluable participants

    Timeframe: 1 month after VAX-31 administration

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Healthy volunteers
Yes

  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).

  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.
Sources for eligibility
clinicaltrials.gov

  • Hope Research InstitutePhoenix, United States
  • Tekton Research at Fort CollinsFort Collins, United States
  • University Clinical Research - DelandDeLand, United States
  • CenExel Research Centers of AmericaHollywood, United States
  • Health AwarenessJupiter, United States
  • Accel Research Sites - LakelandLakeland, United States
  • Accel Research Sites - LargoLargo, United States
  • Precision Clinical ResearchSunrise, United States
  • Velocity ValparaisoValparaiso, United States
  • Johnson County ClinTrialsLenexa, United States
  • AMR LexingtonLexington, United States
  • DM Clinical Research - DetroitDetroit, United States
  • Velocity OmahaOmaha, United States
  • Rochester Clinical ResearchRochester, United States
  • CTI Clinical Research CenterCincinnati, United States
  • Coastal Carolina Research CenterNorth Charleston, United States
  • DelRicht Research - HendersonvilleHendersonville, United States
  • AMR KnxovilleKnoxville, United States
  • Tekton Research at AustinAustin, United States
  • REX Clinical TrialsBeaumont, United States
  • Epic Medical ResearchDeSoto, United States
  • CenExel JBR Clinical ResearchSalt Lake City, United States
  • Charlottesville Medical Research CenterCharlottesville, United States
  • Health Research of Hampton Roads, Inc.Newport News, United States
  • Clinical Research Partners, LLC.Richmond, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)