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En undersøgelse om modificerede RNA-vacciner mod influenza hos raske voksne

9. juni 2026 opdateret af: Pfizer

EN UNDERSØGELSE TIL EVALUERING AF SIKKERHED, TOLERABILITET OG IMMUNOGENICITET AF MODIFICEREDE RNA-VACCINER MOD INFLUENZA HOS SUNDE VOKSNE

Formålet med denne undersøgelse er at lære, om modificerede RNA (modRNA) vacciner til forebyggelse af influenza er:

  • sikker; og
  • hvordan disse vacciner producerer et immunrespons hos generelt raske voksne. Immunrespons er den måde, kroppen beskytter sig selv mod ting, den ser som skadelige eller fremmede.

RNA (også kaldet ribonukleinsyre) er en af ​​to typer nukleinsyre fremstillet af celler. RNA indeholder information, der er blevet kopieret fra DNA (den anden type nukleinsyre). Celler laver flere forskellige former for RNA, og hver form har et specifikt job i cellen. Mange former for RNA har funktioner relateret til fremstilling af proteiner. RNA er også det genetiske materiale af nogle vira i stedet for DNA. RNA kan fremstilles i laboratoriet og bruges i forskningsstudier. Også kaldet ribonukleinsyre.

Influenza er betegnelsen for influenzasygdom. Det er en infektion forårsaget af en virus, der påvirker din mund, næse og hals.

Undersøgelsen søger deltagere, der:

  • er mindst 18 år
  • ikke har modtaget en influenzavaccine inden for de sidste 6 måneder
  • er generelt sunde

Dette studie vil blive opdelt i tre delstudier: Delstudie A (SSA), Delstudie B (SSB) og Delstudie C (SSC).

Alle deltagere, uanset delstudie, vil modtage 1 dosis af en af ​​følgende vacciner som en injektion i deres arm:

  • 1 af modRNA-influenzavaccinerne, der er ved at blive undersøgt; eller
  • en godkendt influenzavaccine godkendt til brug i deres respektive aldersgruppe.

Deltagerne vil være involveret i denne undersøgelse i omkring 6 måneder. I løbet af denne tid vil deltagerne have mindst 3 klinikbesøg.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1202

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

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

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Nøgle inklusionskriterier

Gælder for alle 3 delstudier:

  • deltagere ≥18 år.
  • generelt sunde deltagere.

KUN delstudie C:

- modtagelse af godkendt influenzavaccination for influenzasæsonen 2023-2024 for mindst 6 måneder siden.

Nøgleudelukkelseskriterier

Alle 3 delstudier:

  • diagnosticering af influenza (ved klinisk test) inden for de sidste 6 måneder.
  • immunkompromitterede personer med kendt eller formodet immundefekt
  • modtagelse af eventuelle forsøgs- eller licenserede influenzavacciner inden for 6 måneder.

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: SSA: Influenza ModRNA Vaccine 2A
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSA: Influenza ModRNA Vaccine 3A
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSA: Influenza ModRNA Vaccine 4A
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSA: Influenza ModRNA Vaccine 5A
- Enkelt dosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Aktiv komparator: SSA: QIV1
- Enkelt dosis på dag 1
Biologisk: Quadrivalent influenzavaccine (QIV)
Intramuskulær injektion
Eksperimentel: SSB: Influenza ModRNA Vaccine 3B
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSB: Influenza ModRNA Vaccine 4B
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSB: Influenza ModRNA Vaccine 5B
- Enkelt dosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Aktiv komparator: SSB: QIV2
- Enkeltdosis på dag 1
Biologisk: Quadrivalent influenzavaccine (QIV)
Intramuskulær injektion
Aktiv komparator: SSB: QIV3
- Enkeltdosis på dag 1
Biologisk: Quadrivalent influenzavaccine (QIV)
Intramuskulær injektion
Eksperimentel: SSC: Influenza ModRNA Vaccine 3C
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSC: Influenza ModRNA Vaccine 4C
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSC: Influenza ModRNA Vaccine 5C
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSC: Influenza ModRNA Vaccine 6C
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSC: Influenza ModRNA Vaccine 7C
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSC: Influenza ModRNA Vaccine 8C
- Enkeltdosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Eksperimentel: SSC: Influenza ModRNA Vaccine 9C
- Enkelt dosis på dag 1
Biologisk: Influenza ModRNA-vaccine
Intramuskulær injektion
Aktiv komparator: SSC: QIV2
- Enkeltdosis på dag 1
Biologisk: Quadrivalent influenzavaccine (QIV)
Intramuskulær injektion
Aktiv komparator: SSC: QIV3
- Enkeltdosis på dag 1
Biologisk: Quadrivalent influenzavaccine (QIV)
Intramuskulær injektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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)

23. maj 2024

Primær færdiggørelse (Faktiske)

5. februar 2025

Studieafslutning (Faktiske)

5. februar 2025

Datoer for studieregistrering

Først indsendt

24. maj 2024

Først indsendt, der opfyldte QC-kriterier

30. maj 2024

Først opslået (Faktiske)

31. maj 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C4781013
  • NCT06436703 (Registry Identifier: ClinicalTrials.gov)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil give adgang til individuelle afidentificerede deltagerdata og relaterede undersøgelsesdokumenter (f.eks. protokol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) efter anmodning fra kvalificerede forskere og underlagt visse kriterier, betingelser og undtagelser. Yderligere detaljer om Pfizers datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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 .

Kliniske forsøg med Influenza, menneske

Kliniske forsøg med Influenza ModRNA-vaccine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Germany

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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