En studie for å lære om influensa og vaksinesvar i Covid-19 hos friske mennesker
17. august 2026 oppdatert av: BioNTech SE
En fase 1/2, randomisert, observatørblindet studie for å evaluere sikkerhet, toleranse og immunogenisitet av kombinerte vaksinekandidater mot influensa og Covid-19 hos friske individer
Denne studien skal lære om influensa og vaksiner, enten alene eller når den blandes sammen.
Friske mennesker i alderen 18 år eller eldre kan være med.
Deltakerne vil få ett skudd i hver arm, enten en influensa eller vaksine, alene eller blandet.
Studien varer omtrent 6 måneder, og deltakerne må besøke forskningsstedet minst 3 ganger.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
1353
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
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-
California
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Lake Forest, California, Forente stater, 92630
- Orange County Research Center
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San Diego, California, Forente stater, 92103
- Artemis Institute for Clinical Research
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Walnut Creek, California, Forente stater, 94598
- Diablo Clinical Research, Inc.
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Connecticut
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Milford, Connecticut, Forente stater, 06460
- Clinical Research Consulting
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Florida
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Hialeah, Florida, Forente stater, 33012
- Indago Research & Health Center, Inc
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Miami, Florida, Forente stater, 33176
- Miami Dade Medical Research Institute, LLC
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Miami Lakes, Florida, Forente stater, 33014
- Palm Springs Community Health Center
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Orlando, Florida, Forente stater, 32819
- Headlands Research Orlando
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-
Georgia
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Stockbridge, Georgia, Forente stater, 30281
- Clinical Research Atlanta
-
-
Hawaii
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Honolulu, Hawaii, Forente stater, 96814
- East-West Medical Research Institute
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Missouri
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Chesterfield, Missouri, Forente stater, 63005
- Clinical Research Professionals
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Springfield, Missouri, Forente stater, 65802
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO
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Springfield, Missouri, Forente 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, Forente stater, 68134
- Velocity Clinical Research, Omaha
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Nevada
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Las Vegas, Nevada, Forente stater, 89030
- Las Vegas Clinical Trials
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New Hampshire
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Portsmouth, New Hampshire, Forente stater, 03801
- ActivMed Practices & Research, LLC.
-
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Texas
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Houston, Texas, Forente stater, 77065
- DM Clinical Research- Cyfair
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Mesquite, Texas, Forente stater, 75149
- SMS Clinical Research
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Tomball, Texas, Forente 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, Forente stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Forente stater, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Charlottesville, Virginia, Forente stater, 22911
- Charlottesville Medical Research
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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
Inkluderingskriterier:
- Deltakerne 18 år eller eldre
- Friske deltakere som er bestemt av medisinsk historie, fysisk undersøkelse (hvis klinisk påkrevd) og klinisk skjønn fra etterforskeren skal være kvalifisert for inkludering i studien.
Eksklusjonskriterier:
- Vaksinasjon med all undersøkelses- eller lisensiert 2024-2025 sesongformulering influensa eller vaksine fra Covid-19.
- Behandlet med antivirale terapier for influensa (f.eks. Tamiflu) innen 180 dager før dag 1
Se studiekontakten for ytterligere kvalifiseringsdetaljer.
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: Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
|
Saltvann
Pfizer-Biontech Covid-19-vaksine
|
|
Eksperimentell: Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
|
Saltvann
Pfizer-Biontech Covid-19-vaksine
|
|
Aktiv komparator: Arm C/CC
High Dose COVID-19 Vaccine and Placebo
|
Saltvann
Pfizer-Biontech Covid-19-vaksine
|
|
Eksperimentell: Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
|
Saltvann
Undersøkelsesinfluensavaksine
|
|
Aktiv komparator: Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech Covid-19-vaksine
Lisensiert influensavaksine 1
|
|
Aktiv komparator: Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech Covid-19-vaksine
Lisensiert influensavaksine 2
|
|
Eksperimentell: Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
|
Saltvann
Undersøkelsesinfluensavaksine
|
|
Eksperimentell: Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Saltvann
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentell: Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
|
Saltvann
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentell: Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Saltvann
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentell: Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
|
Saltvann
Undersøkelsesinfluensavaksine
|
|
Eksperimentell: Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Saltvann
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentell: Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Saltvann
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentell: Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Saltvann
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Eksperimentell: Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Saltvann
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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]
|
|
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]
|
|
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]
|
|
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]
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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.
Hjelpsomme linker
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)
11. november 2024
Primær fullføring (Faktiske)
15. juli 2025
Studiet fullført (Faktiske)
15. juli 2025
Datoer for studieregistrering
Først innsendt
8. november 2024
Først innsendt som oppfylte QC-kriteriene
8. november 2024
Først lagt ut (Faktiske)
12. november 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Luftveisinfeksjoner
- Infeksjoner
- Orthomyxoviridae-infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Sykdommer i luftveiene
- Lungesykdommer
- Lungebetennelse, viral
- Lungebetennelse
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- Covid-19
- Influensa, menneske
- Biologiske produkter
- Komplekse blandinger
- Vaksiner
- Virale vaksiner
- Covid-19-vaksiner
Andre studie-ID-numre
- C5261023
- C5261023-C1; C5261023-C2 (Annen identifikator: Alias Study Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
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. .