Een studie om te leren over griep- en covid-19-vaccinreacties bij gezonde mensen
17 augustus 2026 bijgewerkt door: BioNTech SE
Een fase 1/2, gerandomiseerde, waarnemer-blinde studie om de veiligheid, verdraagbaarheid en immunogeniteit van gecombineerde vaccinkandidaten tegen influenza en covid-19 bij gezonde individuen te evalueren
Deze studie is om te leren over griep- en covid -vaccins, alleen of wanneer ze samen gemengd zijn.
Gezonde mensen van 18 jaar of ouder kunnen meedoen.
Deelnemers krijgen één schot in elke arm, een griep- of covid -vaccin, alleen of gemengd.
De studie duurt ongeveer 6 maanden en de deelnemers moeten de onderzoekssite minstens 3 keer bezoeken.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1353
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
California
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Lake Forest, California, Verenigde Staten, 92630
- Orange County Research Center
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San Diego, California, Verenigde Staten, 92103
- Artemis Institute for Clinical Research
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Walnut Creek, California, Verenigde Staten, 94598
- Diablo Clinical Research, Inc.
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-
Connecticut
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Milford, Connecticut, Verenigde Staten, 06460
- Clinical Research Consulting
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Florida
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Hialeah, Florida, Verenigde Staten, 33012
- Indago Research & Health Center, Inc
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Miami, Florida, Verenigde Staten, 33176
- Miami Dade Medical Research Institute, LLC
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Miami Lakes, Florida, Verenigde Staten, 33014
- Palm Springs Community Health Center
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Orlando, Florida, Verenigde Staten, 32819
- Headlands Research Orlando
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Georgia
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Stockbridge, Georgia, Verenigde Staten, 30281
- Clinical Research Atlanta
-
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96814
- East-West Medical Research Institute
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Missouri
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Chesterfield, Missouri, Verenigde Staten, 63005
- Clinical Research Professionals
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Springfield, Missouri, Verenigde Staten, 65802
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO
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Springfield, Missouri, Verenigde Staten, 65807
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68134
- Velocity Clinical Research, Omaha
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-
Nevada
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Las Vegas, Nevada, Verenigde Staten, 89030
- Las Vegas Clinical Trials
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-
New Hampshire
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Portsmouth, New Hampshire, Verenigde Staten, 03801
- ActivMed Practices & Research, LLC.
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Texas
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Houston, Texas, Verenigde Staten, 77065
- DM Clinical Research- Cyfair
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Mesquite, Texas, Verenigde Staten, 75149
- SMS Clinical Research
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Tomball, Texas, Verenigde Staten, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Verenigde Staten, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22911
- Charlottesville Medical Research
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusiecriteria:
- Deelnemers 18 jaar of ouder
- Gezonde deelnemers die worden bepaald door medische geschiedenis, lichamelijk onderzoek (indien klinisch vereist) en klinisch oordeel van de onderzoeker om in aanmerking te komen voor opname in het onderzoek.
Uitsluitingscriteria:
- Vaccinatie met eventuele onderzoeks- of gelicentieerde 2024-2025 seizoensformuleringsformulering influenza of covid-19 vaccin.
- Behandeld met antivirale therapieën voor influenza (bijv. Tamiflu) binnen 180 dagen voorafgaand aan dag 1
Raadpleeg het onderzoekscontact voor verdere gegevens over de geschiktheid.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Pfizer-Biontech Covid-19 vaccin
|
|
Experimenteel: Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Pfizer-Biontech Covid-19 vaccin
|
|
Actieve vergelijker: Arm C/CC
High Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Pfizer-Biontech Covid-19 vaccin
|
|
Experimenteel: Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
|
Zoutoplossing
Onderzoeksgriepvaccin
|
|
Actieve vergelijker: Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech Covid-19 vaccin
Gelicentieerde griepvaccin 1
|
|
Actieve vergelijker: Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
|
Pfizer-Biontech Covid-19 vaccin
Gelicentieerde griepvaccin 2
|
|
Experimenteel: Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
|
Zoutoplossing
Onderzoeksgriepvaccin
|
|
Experimenteel: Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimenteel: Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimenteel: Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimenteel: Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
|
Zoutoplossing
Onderzoeksgriepvaccin
|
|
Experimenteel: Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimenteel: Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimenteel: Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimenteel: Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Zoutoplossing
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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]
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
11 november 2024
Primaire voltooiing (Werkelijk)
15 juli 2025
Studie voltooiing (Werkelijk)
15 juli 2025
Studieregistratiedata
Eerst ingediend
8 november 2024
Eerst ingediend dat voldeed aan de QC-criteria
8 november 2024
Eerst geplaatst (Werkelijk)
12 november 2024
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Luchtweginfecties
- Infecties
- Orthomyxoviridae-infecties
- RNA-virusinfecties
- Virusziekten
- Ziekten van de luchtwegen
- Longziekten
- Longontsteking, viraal
- Longontsteking
- Coronavirus-infecties
- Coronaviridae-infecties
- Nidovirales-infecties
- COVID-19
- Influenza, mens
- Biologische producten
- Complexe mengsels
- Vaccins
- Virale vaccins
- Covid-19-vaccins
Andere studie-ID-nummers
- C5261023
- C5261023-C1; C5261023-C2 (Andere identificatie: Alias Study Number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .