A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified December 2025 by BioNTech SE
Sponsor
BioNTech SE
Information Provided by (Responsible Party)
BioNTech SE
Clinicaltrials.gov Identifier
NCT06821061
Other Study ID Numbers:
C6271001
First Submitted
February 6, 2025
First Posted
February 10, 2025
Last Update Posted
January 25, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
InfluenzaCOVID-19 (Coronavirus Disease 2019)
Biological: Investigational COVID-19 VaccineBiological: Investigational COVID-19 VaccineBiological: Investigational COVID-19 VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineBiological: Licensed COVID-19 VaccineBiological: Licensed Influenza Vaccine 1Combination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineBiological: Licensed COVID-19 VaccineBiological: Licensed Influenza Vaccine 2Combination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineBiological: Licensed COVID-19 VaccineBiological: Licensed Influenza Vaccine 3Biological: Licensed Influenza Vaccine 2Biological: Investigational COVID-19 VaccineBiological: Investigational COVID-19 VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineCombination Product: Investigational Influenza and COVID-19 Combination VaccineBiological: Investigational Influenza VaccineBiological: Investigational Influenza VaccineBiological: Licensed COVID-19 VaccineBiological: Licensed Influenza Vaccine 3

Study Design

Study TypeInterventional
Actual Enrollment2650 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitleA PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
Study Start DateFebruary 9, 2025
Actual Primary Completion DateDecember 16, 2025
Actual Study Completion DateDecember 16, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A
Low Dose COVID-19 Vaccine (1a)
Biological: Investigational COVID-19 Vaccine
Investigational COVID-19 Vaccine
Arm B
Low Dose COVID-19 Vaccine ( 1b)
Biological: Investigational COVID-19 Vaccine
Investigational COVID-19 Vaccine
Arm C
Low Dose COVID-19 Vaccine ( 1c)
Biological: Investigational COVID-19 Vaccine
Investigational COVID-19 Vaccine
Arm D
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm E
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm F
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm G
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm H
Licensed COVID-19 Vaccine
Biological: Licensed COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Arm I
Licensed Influenza Vaccine (1)
Biological: Licensed Influenza Vaccine 1
Licensed Influenza Vaccine 1
Arm J
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm K
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm L
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm M
Licensed COVID-19 Vaccine
Biological: Licensed COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Arm N
Licensed Influenza Vaccine (2)
Biological: Licensed Influenza Vaccine 2
Licensed Influenza Vaccine 2
Arm AA
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm BB
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm CC
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm DD
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm EE
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm FF
Licensed COVID-19 Vaccine
Biological: Licensed COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Arm GG
Licensed Influenza Vaccine (3)
Biological: Licensed Influenza Vaccine 3
Licensed Influenza Vaccine 3
Arm HH
Licensed Influenza Vaccine (2)
Biological: Licensed Influenza Vaccine 2
Licensed Influenza Vaccine 2
Arm II
Low Dose COVID-19 Vaccine ( 1b)
Biological: Investigational COVID-19 Vaccine
Investigational COVID-19 Vaccine
Arm JJ
Low Dose COVID-19 Vaccine ( 1c)
Biological: Investigational COVID-19 Vaccine
Investigational COVID-19 Vaccine
Arm KK
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm LL
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm MM
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm NN
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm OO
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
Investigational Combined Influenza and COVID-19 Vaccine
Arm PP
Medium Dose Investigational Influenza Vaccine (1)
Biological: Investigational Influenza Vaccine
Investigational Influenza Vaccine
Arm QQ
High Dose Investigational Influenza Vaccine (2)
Biological: Investigational Influenza Vaccine
Investigational Influenza Vaccine
Arm RR
Licensed COVID-19 Vaccine
Biological: Licensed COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
Arm SS
Licensed Influenza Vaccine (3)
Biological: Licensed Influenza Vaccine 3
Licensed Influenza Vaccine 3

Outcome Measures

Primary Outcome Measures
  1. Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
  2. Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
  3. Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
  4. Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
Secondary Outcome Measures
  1. GMTs before and through 1 month following investigational product administration

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Inclusion criteria:
Participants 18 years of age or older
Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study
Exclusion Criteria
Inclusion criteria:
Participants 18 years of age or older
Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study Exclusion criteria:
Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment
Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment.
Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1. Refer to the study contact for further eligibility details

Contacts and Locations

Sponsors and CollaboratorsBioNTech SE
Locations
Anaheim Clinical Trials, LLC | Anaheim California, United States, 92801Orange County Research Center | Lake Forest California, United States, 92630Artemis Institute for Clinical Research | Riverside California, United States, 92503Artemis Institute for Clinical Research | San Diego California, United States, 92103Diablo Clinical Research, Inc. | Walnut Creek California, United States, 94598Clinical Research Consulting | Milford Connecticut, United States, 06460Alliance for Multispecialty Research, LLC | Doral Florida, United States, 33172Indago Research & Health Center, Inc | Hialeah Florida, United States, 33012Miami Dade Medical Research Institute, LLC | Miami Florida, United States, 33176Palm Springs Community Health Center | Miami Lakes Florida, United States, 33014Clinical Research Atlanta | Stockbridge Georgia, United States, 30281East-West Medical Research Institute | Honolulu Hawaii, United States, 96814Clinical Research Professionals | Chesterfield Missouri, United States, 63005Las Vegas Clinical Trials | North Las Vegas Nevada, United States, 89030Upstate Global Health Institute | East Syracuse New York, United States, 13057University of Rochester Medical Center | Rochester New York, United States, 14642Trial Management Associates - Wilmington - Floral Parkway | Wilmington North Carolina, United States, 28403Centricity Research Columbus Ohio Multispecialty | Columbus Ohio, United States, 43213DM Clinical Research - Philadelphia | Philadelphia Pennsylvania, United States, 19107Coastal Carolina Research Center | North Charleston South Carolina, United States, 29405AMR Clinical | Knoxville Tennessee, United States, 37909AMR Clinical | Knoxville Tennessee, United States, 37920Clinical Research Associates Inc | Nashville Tennessee, United States, 37203Headlands Horizons, LLC dba Headlands Research-Brownsville | Brownsville Texas, United States, 78526DM Clinical Research- Cyfair | Houston Texas, United States, 77065SMS Clinical Research | Mesquite Texas, United States, 75149Dynamed Clinical Research, LP d/b/a DM Clinical Research | Tomball Texas, United States, 77375J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City Utah, United States, 84109J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City Utah, United States, 84121Charlottesville Medical Research | Charlottesville Virginia, United States, 22911Kaiser Permanente Washington Health Research Institute (KPWHRI) | Seattle Washington, United States, 98101
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer