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

NCT06821061
clinicaltrials.gov
Phase
Phase 1/Phase 2
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Recruitment status
Completed
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Participants
2,650
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Lead sponsor
BioNTech SE
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Start date
2025-02-10
clinicaltrials.gov
Number of sites
31
clinicaltrials.gov

Summary
The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older. All participants in this study will receive only 1 shot to their arm, either a flu or COVID vaccine, alone or mixed. Participants will take part in this study for about 6 months, and participants will need to visit the clinical study site at least 4 times.
clinicaltrials.gov
Short title
A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
clinicaltrials.gov
Official title
A 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2025-12-17
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First posted
2025-02-11
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Registry last updated
2026-01-26
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Primary completion date
2025-12-17
clinicaltrials.gov
Start date
2025-02-10
clinicaltrials.gov

Actual participants
2,650
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Participants
2,650
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
31
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
BioNTech SE
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06821061
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06821061
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of participants reporting prompted local reactions within 7 days following investigational product administration

    Timeframe: Day 7

  2. Percentage of participants reporting prompted systemic events within 7 days following investigational product administration

    Timeframe: Day 7

  3. Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration

    Timeframe: 1 month

  4. Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration

    Timeframe: 6 months

  1. GMTs before and through 1 month following investigational product administration

    Timeframe: Before vaccination through to 1 month after vaccination

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • 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

  • 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

Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical Trials, LLCAnaheim, United States
  • Orange County Research CenterLake Forest, United States
  • Artemis Institute for Clinical ResearchRiverside, United States
  • Artemis Institute for Clinical ResearchSan Diego, United States
  • Diablo Clinical Research, Inc.Walnut Creek, United States
  • Clinical Research ConsultingMilford, United States
  • Alliance for Multispecialty Research, LLCDoral, United States
  • Indago Research & Health Center, IncHialeah, United States
  • Miami Dade Medical Research Institute, LLCMiami, United States
  • Palm Springs Community Health CenterMiami Lakes, United States
  • Clinical Research AtlantaStockbridge, United States
  • East-West Medical Research InstituteHonolulu, United States
  • Clinical Research ProfessionalsChesterfield, United States
  • Las Vegas Clinical TrialsNorth Las Vegas, United States
  • Upstate Global Health InstituteEast Syracuse, United States
  • University of Rochester Medical CenterRochester, United States
  • Trial Management Associates - Wilmington - Floral ParkwayWilmington, United States
  • Centricity Research Columbus Ohio MultispecialtyColumbus, United States
  • DM Clinical Research - PhiladelphiaPhiladelphia, United States
  • Coastal Carolina Research CenterNorth Charleston, United States
  • AMR ClinicalKnoxville, United States
  • AMR ClinicalKnoxville, United States
  • Clinical Research Associates IncNashville, United States
  • Headlands Horizons, LLC dba Headlands Research-BrownsvilleBrownsville, United States
  • DM Clinical Research- CyfairHouston, United States

And 6 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • C6271001-C1
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (1)