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En studie om modifiserte RNA-vaksiner mot influensa hos friske voksne

9. juni 2026 oppdatert av: Pfizer

EN STUDIE FOR Å EVALUERE SIKKERHETEN, TOLERABILITETEN OG IMMUNOGENISITETEN TIL MODIFISERT RNA-VAKSIN MOT INFLUENSA HOS SUNE VOKSNE

Formålet med denne studien er å finne ut om modifiserte RNA (modRNA) vaksiner for forebygging av influensa er:

  • sikker; og
  • hvordan disse vaksinene produserer en immunrespons hos generelt friske voksne. Immunrespons er måten kroppen beskytter seg mot ting den ser på som skadelig eller fremmed.

RNA (også kalt ribonukleinsyre) er en av to typer nukleinsyre laget av celler. RNA inneholder informasjon som er kopiert fra DNA (den andre typen nukleinsyre). Celler lager flere forskjellige former for RNA, og hver form har en bestemt jobb i cellen. Mange former for RNA har funksjoner knyttet til å lage proteiner. RNA er også arvestoffet til noen virus i stedet for DNA. RNA kan lages i laboratoriet og brukes i forskningsstudier. Også kalt ribonukleinsyre.

Influensa er betegnelsen på influensasykdom. Det er en infeksjon forårsaket av et virus som påvirker munn, nese og svelg.

Studien søker etter deltakere som:

  • er minst 18 år
  • ikke har mottatt influensavaksine de siste 6 månedene
  • er generelt sunne

Denne studien vil bli delt inn i tre delstudier: Delstudie A (SSA), Delstudie B (SSB), og Delstudie C (SSC).

Alle deltakere, uavhengig av delstudie, vil motta 1 dose av en av følgende vaksiner som en injeksjon i armen:

  • 1 av modRNA-influensavaksinen som studeres; eller
  • en godkjent influensavaksine godkjent for bruk i deres respektive aldersgruppe.

Deltakerne vil være involvert i denne studien i ca. 6 måneder. I løpet av denne tiden vil deltakerne ha minst 3 klinikkbesøk.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

1202

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alabama
      • Mobile, Alabama, Forente stater, 36608
        • AMR Clinical
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85260
        • Headlands Research - Scottsdale
    • California
      • Anaheim, California, Forente stater, 92801
        • Anaheim Clinical Trials, LLC
      • Lake Forest, California, Forente stater, 92630
        • Orange County Research Center
      • San Diego, California, Forente stater, 92103
        • Artemis Institute for Clinical Research
      • Walnut Creek, California, Forente stater, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Milford, Connecticut, Forente stater, 06460
        • Clinical Research Consulting
    • Florida
      • Hialeah, Florida, Forente stater, 33012
        • Indago Research & Health Center, Inc
      • Hollywood, Florida, Forente stater, 33024
        • Research Centers of America
      • Hollywood, Florida, Forente stater, 33024
        • Research Centers of America ( Hollywood )
      • Miami Lakes, Florida, Forente stater, 33014
        • Palm Springs Community Health Center
      • Orlando, Florida, Forente stater, 32801
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, Forente stater, 32819
        • Headlands Research Orlando
      • South Miami, Florida, Forente stater, 33143
        • Qps-Mra, Llc
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96814
        • East-West Medical Research Institute
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70119
        • Alliance for Multispecialty Research, LLC
    • Minnesota
      • Saint Paul, Minnesota, Forente stater, 55114
        • Prism Research LLC dba Nucleus Network
    • Missouri
      • Chesterfield, Missouri, Forente stater, 63005
        • Clinical Research Professionals
      • Kansas City, Missouri, Forente stater, 64114
        • Alliance for Multispecialty Research, LLC
    • New York
      • Rochester, New York, Forente stater, 14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Durham, North Carolina, Forente stater, 27703
        • Duke Vaccine and Trials Unit
      • Raleigh, North Carolina, Forente stater, 27612
        • M3 Wake Research, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • DM Clinical Research - Philadelphia
    • Texas
      • Brownsville, Texas, Forente stater, 78526
        • Headlands Horizons LLC
      • Mesquite, Texas, Forente stater, 75149
        • SMS Clinical Research
      • San Antonio, Texas, Forente stater, 78229
        • Clinical Trials of Texas, LLC
      • San Antonio, Texas, Forente stater, 78229
        • Clinical Trials of Texas, LLC dba Flourish Research
      • Tomball, Texas, Forente stater, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Utah
      • Salt Lake City, Utah, Forente stater, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, Forente stater, 84121
        • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22911
        • Charlottesville Medical Research
      • Norfolk, Virginia, Forente stater, 23502
        • AMR Clinical

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Viktige inkluderingskriterier

Gjelder alle 3 delstudiene:

  • deltakere ≥18 år.
  • generelt friske deltakere.

KUN delstudie C:

- mottak av lisensiert influensavaksinasjon for influensasesongen 2023-2024 for minst 6 måneder siden.

Nøkkeleksklusjonskriterier

Alle 3 delstudiene:

  • diagnostisering av influensa (ved klinisk testing) de siste 6 månedene.
  • immunkompromitterte individer med kjent eller mistenkt immunsvikt
  • mottak av eventuelle undersøkelses- eller lisensierte influensavaksiner innen 6 måneder.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SSA: Influensa ModRNA-vaksine 2A
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSA: Influensa ModRNA-vaksine 3A
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSA: Influensa ModRNA-vaksine 4A
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSA: Influensa ModRNA-vaksine 5A
- Enkeltdose på dag 1
Intramuskulær injeksjon
Aktiv komparator: SSA: QIV1
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSB: Influensa ModRNA-vaksine 3B
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSB: Influensa ModRNA-vaksine 4B
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSB: Influensa ModRNA-vaksine 5B
- Enkeltdose på dag 1
Intramuskulær injeksjon
Aktiv komparator: SSB: QIV2
- Enkeltdose på dag 1
Intramuskulær injeksjon
Aktiv komparator: SSB: QIV3
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSC: Influensa ModRNA-vaksine 3C
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSC: Influensa ModRNA-vaksine 4C
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSC: Influensa ModRNA-vaksine 5C
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSC: Influensa ModRNA-vaksine 6C
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSC: Influensa ModRNA-vaksine 7C
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSC: Influensa ModRNA-vaksine 8C
- Enkeltdose på dag 1
Intramuskulær injeksjon
Eksperimentell: SSC: Influensa ModRNA-vaksine 9C
- Enkeltdose på dag 1
Intramuskulær injeksjon
Aktiv komparator: SSC: QIV2
- Enkeltdose på dag 1
Intramuskulær injeksjon
Aktiv komparator: SSC: QIV3
- Enkeltdose på dag 1
Intramuskulær injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
Tidsramme: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Tidsramme: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Tidsramme: From study vaccination on Day 1 through 4 weeks after study vaccination
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
From study vaccination on Day 1 through 4 weeks after study vaccination
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
From study vaccination on Day 1 through 6 months after study vaccination
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Tidsramme: From study vaccination on Day 1 through 6 months after study vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
From study vaccination on Day 1 through 6 months after study vaccination

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
Tidsramme: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Tidsramme: From before study vaccination on Day 1 up to 4 weeks after study vaccination
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point after vaccination.
From before study vaccination on Day 1 up to 4 weeks after study vaccination
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Tidsramme: 4 weeks after study vaccination
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with at least a 4-fold rise at the time point of interest.
4 weeks after study vaccination
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Tidsramme: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
Tidsramme: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Tidsramme: From before study vaccination on Day 1 up to 4 weeks after study vaccination
From before study vaccination on Day 1 up to 4 weeks after study vaccination
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Tidsramme: 4 weeks after study vaccination
4 weeks after study vaccination
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Tidsramme: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. mai 2024

Primær fullføring (Faktiske)

5. februar 2025

Studiet fullført (Faktiske)

5. februar 2025

Datoer for studieregistrering

Først innsendt

24. mai 2024

Først innsendt som oppfylte QC-kriteriene

30. mai 2024

Først lagt ut (Faktiske)

31. mai 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere