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En klinisk undersøgelse til evaluering af sikkerhed, tolerabilitet og immunogenicitet af VAX-31 sammen med influenzavaccine hos voksne ≥ 50 år

10. november 2026 opdateret af: Vaxcyte, Inc.

En fase 3, randomiseret, dobbeltblind, placebokontrolleret klinisk undersøgelse for at evaluere sikkerheden, tolerabiliteten og immunogeniteten af VAX-31 samtidigt administreret med sæsoninfluenzavaccine hos raske forsøgspersoner på 50 år og ældre

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1390

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85032
        • Hope Research Institute
    • Colorado
      • Fort Collins, Colorado, Forenede Stater, 80525
        • Tekton Research at Fort Collins
    • Florida
      • DeLand, Florida, Forenede Stater, 32720-0834
        • University Clinical Research - Deland
      • Hollywood, Florida, Forenede Stater, 33024
        • CenExel Research Centers of America
      • Jupiter, Florida, Forenede Stater, 33458
        • Health Awareness
      • Lakeland, Florida, Forenede Stater, 33803
        • Accel Research Sites - Lakeland
      • Largo, Florida, Forenede Stater, 33777
        • Accel Research Sites - Largo
      • Sunrise, Florida, Forenede Stater, 33351
        • Precision Clinical Research
    • Indiana
      • Valparaiso, Indiana, Forenede Stater, 46383
        • Velocity Valparaiso
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Johnson County ClinTrials
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • AMR Lexington
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48076
        • DM Clinical Research - Detroit
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68134
        • Velocity Omaha
    • New York
      • Rochester, New York, Forenede Stater, 14609
        • Rochester Clinical Research
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • CTI Clinical Research Center
    • South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29405
        • Coastal Carolina Research Center
    • Tennessee
      • Hendersonville, Tennessee, Forenede Stater, 37075
        • DelRicht Research - Hendersonville
      • Knoxville, Tennessee, Forenede Stater, 37909
        • AMR Knxoville
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Tekton Research at Austin
      • Beaumont, Texas, Forenede Stater, 77701
        • REX Clinical Trials
      • DeSoto, Texas, Forenede Stater, 75115
        • Epic Medical Research
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84107
        • CenExel JBR Clinical Research
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22911
        • Charlottesville Medical Research Center
      • Newport News, Virginia, Forenede Stater, 23606
        • Health Research of Hampton Roads, Inc.
      • Richmond, Virginia, Forenede Stater, 23226
        • Clinical Research Partners, LLC.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VAX-31 + SIV

Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1.
Biologisk: 31-valent pneumococcal conjugate vaccine

0.5 mL of VAX-31 will be administered into the deltoid muscle

Biologisk: Seasonal Influenza Vaccine (SIV) (Flublok)

0.5 mL of SIV into the deltoid muscle

Biologisk: Placebo

0.5mL of placebo (normal saline) into the deltoid muscle
Eksperimentel: Placebo + SIV

Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1.
Biologisk: 31-valent pneumococcal conjugate vaccine

0.5 mL of VAX-31 will be administered into the deltoid muscle

Biologisk: Seasonal Influenza Vaccine (SIV) (Flublok)

0.5 mL of SIV into the deltoid muscle

Biologisk: Placebo

0.5mL of placebo (normal saline) into the deltoid muscle

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
For hver af de 32 serotyper (de 31 serotyper inkluderet i VAX-31, og serotype 20B), forholdet (co-administrationsgruppe til sekventiel administrationsgruppe) af opsonofagocytisk aktivitet (OPA) geometrisk middelværdi af titre (GMT) hos evaluerbare deltagere
Tidsramme: 1 måned efter VAX-31 vaccination
1 måned efter VAX-31 vaccination
For hver af stammene i SIV, forholdet (ko-administreringsgruppe til sekventiel administrationsgruppe) af hæmagglutinationshæmning (HAI) GMT hos evaluerbare deltagere
Tidsramme: 1 måned efter SIV-administration
1 måned efter SIV-administration
Procentdel af deltagere, der rapporterede ønskede lokale bivirkninger (AE) inden for 7 dage efter vaccination på dag 1 og måned 1 (rødme, hævelse og smerte på injektionsstedet) i hver gruppe
Tidsramme: 7 dage efter hver vaccination
7 dage efter hver vaccination
Procentdel af deltagere, der rapporterer forespurgte systemiske bivirkninger inden for 7 dage efter vaccination på dag 1 og måned 1 (feber, hovedpine, træthed, muskelsmerter og ledsmerter) i hver gruppe
Tidsramme: 7 dage efter hver vaccination
7 dage efter hver vaccination
Procentdel af deltagere, der rapporterer uopfordrede bivirkninger inden for 1 måned efter vaccination på dag 1 og måned 1 i hver gruppe
Tidsramme: 7 dage efter hver vaccination
7 dage efter hver vaccination
Procentdel af deltagere, der rapporterer NOCI, MAAE og SAE inden for 6 måneder efter sidste vaccination i hver gruppe
Tidsramme: 6 måneder efter sidste vaccination
6 måneder efter sidste vaccination

Sekundære resultatmål

Resultatmål
Tidsramme
For hver af de 32 serotyper (de 31 serotyper inkluderet i VAX-31 og serotype 20B), forholdet (co-administrationsgruppen til sekventiel administrationsgruppe) af IgG geometriske gennemsnitskoncentrationer (GMC) i evaluerbare deltagere
Tidsramme: 1 måned efter VAX-31 administration
1 måned efter VAX-31 administration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vaxcyte, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. januar 2026

Primær færdiggørelse (Faktiske)

21. oktober 2026

Studieafslutning (Faktiske)

21. oktober 2026

Datoer for studieregistrering

Først indsendt

22. januar 2026

Først indsendt, der opfyldte QC-kriterier

22. januar 2026

Først opslået (Faktiske)

26. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VAX31-106

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.

IPD-delingstidsramme

Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.

IPD-delingsadgangskriterier

Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner