En studie för att lära sig om influensa och vaccinsvar med covid-19 hos friska människor
17 augusti 2026 uppdaterad av: BioNTech SE
En fas 1/2, randomiserad, observatörsblindad studie för att utvärdera säkerheten, tolerabiliteten och immunogeniciteten hos kombinerade vaccinkandidater mot influensa och covid-19 hos friska individer
Denna studie är att lära sig om influensa- och covidvacciner, antingen ensamma eller när de blandas ihop.
Friska människor som är 18 år eller äldre kan gå med.
Deltagarna kommer att få ett skott i varje arm, antingen ett influensa eller ett vaccin, ensamt eller blandat.
Studien varar cirka 6 månader, och deltagarna måste besöka forskningsplatsen minst tre gånger.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
1353
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Lake Forest, California, Förenta staterna, 92630
- Orange County Research Center
-
San Diego, California, Förenta staterna, 92103
- Artemis Institute for Clinical Research
-
Walnut Creek, California, Förenta staterna, 94598
- Diablo Clinical Research, Inc.
-
-
Connecticut
-
Milford, Connecticut, Förenta staterna, 06460
- Clinical Research Consulting
-
-
Florida
-
Hialeah, Florida, Förenta staterna, 33012
- Indago Research & Health Center, Inc
-
Miami, Florida, Förenta staterna, 33176
- Miami Dade Medical Research Institute, LLC
-
Miami Lakes, Florida, Förenta staterna, 33014
- Palm Springs Community Health Center
-
Orlando, Florida, Förenta staterna, 32819
- Headlands Research Orlando
-
-
Georgia
-
Stockbridge, Georgia, Förenta staterna, 30281
- Clinical Research Atlanta
-
-
Hawaii
-
Honolulu, Hawaii, Förenta staterna, 96814
- East-West Medical Research Institute
-
-
Missouri
-
Chesterfield, Missouri, Förenta staterna, 63005
- Clinical Research Professionals
-
Springfield, Missouri, Förenta staterna, 65802
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO
-
Springfield, Missouri, Förenta staterna, 65807
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna, 68134
- Velocity Clinical Research, Omaha
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89030
- Las Vegas Clinical Trials
-
-
New Hampshire
-
Portsmouth, New Hampshire, Förenta staterna, 03801
- ActivMed Practices & Research, LLC.
-
-
Texas
-
Houston, Texas, Förenta staterna, 77065
- DM Clinical Research- Cyfair
-
Mesquite, Texas, Förenta staterna, 75149
- SMS Clinical Research
-
Tomball, Texas, Förenta staterna, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Salt Lake City, Utah, Förenta staterna, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22911
- Charlottesville Medical Research
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inkluderingskriterier:
- Deltagarna 18 år eller äldre
- Friska deltagare som bestäms av medicinsk historia, fysisk undersökning (om kliniskt krävs) och klinisk bedömning av utredaren är berättigad till inkludering i studien.
Uteslutningskriterier:
- Vaccination med eventuella undersökningar eller licensierade 2024-2025 säsongsformuleringsinfluensa eller vaccin mot 19.
- Behandlas med antivirala terapier för influensa (t.ex. Tamiflu) inom 180 dagar före dag 1
Se studiekontakten för ytterligare information om behörighet.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
|
Salin
Pfizer-biontech covid-19 vaccin
|
|
Experimentell: Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
|
Salin
Pfizer-biontech covid-19 vaccin
|
|
Aktiv komparator: Arm C/CC
High Dose COVID-19 Vaccine and Placebo
|
Salin
Pfizer-biontech covid-19 vaccin
|
|
Experimentell: Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
|
Salin
Utredningsinfluensa -vaccin
|
|
Aktiv komparator: Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
|
Pfizer-biontech covid-19 vaccin
Licensierad influensavaccin 1
|
|
Aktiv komparator: Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
|
Pfizer-biontech covid-19 vaccin
Licensierad influensavaccin 2
|
|
Experimentell: Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
|
Salin
Utredningsinfluensa -vaccin
|
|
Experimentell: Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salin
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimentell: Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
|
Salin
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimentell: Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salin
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimentell: Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
|
Salin
Utredningsinfluensa -vaccin
|
|
Experimentell: Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salin
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimentell: Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salin
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimentell: Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salin
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimentell: Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salin
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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]
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 november 2024
Primärt slutförande (Faktisk)
15 juli 2025
Avslutad studie (Faktisk)
15 juli 2025
Studieregistreringsdatum
Först inskickad
8 november 2024
Först inskickad som uppfyllde QC-kriterierna
8 november 2024
Första postat (Faktisk)
12 november 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägsinfektioner
- Infektioner
- Orthomyxoviridae-infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- Covid-19
- Influensa, människa
- Biologiska produkter
- Komplexa blandningar
- Vacciner
- Virala vacciner
- Covid-19 vacciner
Andra studie-ID-nummer
- C5261023
- C5261023-C1; C5261023-C2 (Annan identifierare: Alias Study Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .