En undersøgelse for at lære om influenza og covid-19-vaccine-reaktioner hos raske mennesker
17. august 2026 opdateret af: BioNTech SE
En fase 1/2, randomiseret, observatørblindet undersøgelse for at evaluere sikkerheden, tolerabiliteten og immunogeniciteten af kombinerede vaccinkandidater mod influenza og covid-19 hos raske individer
Denne undersøgelse er at lære om influenza og covidvacciner, enten alene eller når de blandes sammen.
Sunde mennesker på 18 år eller ældre kan deltage.
Deltagerne får et skud i hver arm, enten en influenza- eller covid vaccine, alene eller blandet.
Undersøgelsen varer ca. 6 måneder, og deltagerne er nødt til at besøge forskningsstedet mindst 3 gange.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1353
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
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California
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Lake Forest, California, Forenede Stater, 92630
- Orange County Research Center
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San Diego, California, Forenede Stater, 92103
- Artemis Institute for Clinical Research
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Walnut Creek, California, Forenede Stater, 94598
- Diablo Clinical Research, Inc.
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Connecticut
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Milford, Connecticut, Forenede Stater, 06460
- Clinical Research Consulting
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Florida
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Hialeah, Florida, Forenede Stater, 33012
- Indago Research & Health Center, Inc
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Miami, Florida, Forenede Stater, 33176
- Miami Dade Medical Research Institute, LLC
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Miami Lakes, Florida, Forenede Stater, 33014
- Palm Springs Community Health Center
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Orlando, Florida, Forenede Stater, 32819
- Headlands Research Orlando
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Georgia
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Stockbridge, Georgia, Forenede Stater, 30281
- Clinical Research Atlanta
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96814
- East-West Medical Research Institute
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Missouri
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Chesterfield, Missouri, Forenede Stater, 63005
- Clinical Research Professionals
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Springfield, Missouri, Forenede Stater, 65802
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO
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Springfield, Missouri, Forenede Stater, 65807
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68134
- Velocity Clinical Research, Omaha
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89030
- Las Vegas Clinical Trials
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New Hampshire
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Portsmouth, New Hampshire, Forenede Stater, 03801
- ActivMed Practices & Research, LLC.
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Texas
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Houston, Texas, Forenede Stater, 77065
- DM Clinical Research- Cyfair
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Mesquite, Texas, Forenede Stater, 75149
- SMS Clinical Research
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Tomball, Texas, Forenede Stater, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, Forenede Stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Forenede Stater, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22911
- Charlottesville Medical Research
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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
Inkluderingskriterier:
- Deltagerne 18 år eller ældre
- Sunde deltagere, der er bestemt af medicinsk historie, fysisk undersøgelse (hvis klinisk krævet) og klinisk vurdering af efterforskeren for at være berettiget til optagelse i undersøgelsen.
Ekskluderingskriterier:
- Vaccination med enhver undersøgelse eller licenseret sæsonformulering 2024-2025-sæsonformulering eller covid-19-vaccine.
- Behandlet med antivirale terapier for influenza (f.eks. Tamiflu) inden for 180 dage før dag 1
Se undersøgelseskontakten for yderligere detaljer om støtteberettigelse.
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: Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
|
Saltvand
Pfizer-Biontech Covid-19 Vaccine
|
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Eksperimentel: Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
|
Saltvand
Pfizer-Biontech Covid-19 Vaccine
|
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Aktiv komparator: Arm C/CC
High Dose COVID-19 Vaccine and Placebo
|
Saltvand
Pfizer-Biontech Covid-19 Vaccine
|
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Eksperimentel: Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
|
Saltvand
Undersøgelsesinfluenzavaccine
|
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Aktiv komparator: Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech Covid-19 Vaccine
Licenseret influenzavaccine 1
|
|
Aktiv komparator: Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech Covid-19 Vaccine
Licenseret influenzavaccine 2
|
|
Eksperimentel: Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
|
Saltvand
Undersøgelsesinfluenzavaccine
|
|
Eksperimentel: Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Saltvand
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentel: Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
|
Saltvand
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentel: Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Saltvand
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentel: Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
|
Saltvand
Undersøgelsesinfluenzavaccine
|
|
Eksperimentel: Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Saltvand
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentel: Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Saltvand
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentel: Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Saltvand
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentel: Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Saltvand
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination.
Local reactions were graded per the 'Local Reaction Grading Scale' per protocol.
Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination.
Local reactions were graded per the 'Local Reaction Grading Scale' per protocol.
Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination.
Systemic events were graded per the 'Systemic Events Grading Scale' per protocol.
Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Tidsramme: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination.
Systemic events were graded per the 'Systemic Events Grading Scale' per protocol.
Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
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|
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
Tidsramme: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
AEs included both serious and all non-serious AEs.
Serious AE (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.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
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Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
Tidsramme: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
AEs included both serious and all non-serious AEs.
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.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Tidsramme: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
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, and any other pre-specified criteria in protocol of the study or other important medical event.
Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
|
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
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Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Tidsramme: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
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, and any other pre-specified criteria in protocol of the study or other important medical event.
Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
|
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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.
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)
11. november 2024
Primær færdiggørelse (Faktiske)
15. juli 2025
Studieafslutning (Faktiske)
15. juli 2025
Datoer for studieregistrering
Først indsendt
8. november 2024
Først indsendt, der opfyldte QC-kriterier
8. november 2024
Først opslået (Faktiske)
12. november 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejsinfektioner
- Infektioner
- Orthomyxoviridae infektioner
- RNA-virusinfektioner
- Virussygdomme
- Luftvejssygdomme
- Lungesygdomme
- Lungebetændelse, viral
- Lungebetændelse
- Coronavirus infektioner
- Coronaviridae infektioner
- Nidovirales infektioner
- COVID-19
- Influenza, menneske
- Biologiske produkter
- Komplekse blandinger
- Vacciner
- Virale vacciner
- Vacciner mod covid-19
Andre undersøgelses-id-numre
- C5261023
- C5261023-C1; C5261023-C2 (Anden identifikator: Alias Study Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
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Ingen
produkt fremstillet i og eksporteret fra U.S.A.
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 .