> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-how-the-flu-and-covid-19-vaccines-act-71038789-3e8b-43af-b2b0-b764317fba68 > Record changed: 2026-10-13 # A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People NCT06821061 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) Participants 2,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) Lead sponsor BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) Start date 2025-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) Number of sites 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Short title** A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Dates **Completion date** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **First posted** 2025-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Registry last updated** 2026-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Primary completion date** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Start date** 2025-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Size and sites **Actual participants** 2,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Participants** 2,650 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Number of sites** 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Lead sponsor** BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Identifiers **Registry ID** NCT06821061 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **ClinicalTrials.gov ID** NCT06821061 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 1. GMTs before and through 1 month following investigational product administration Timeframe: Before vaccination through to 1 month after vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C6271001) ### Other registry identifiers - C6271001-C1 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06821061) ## Related records ### Drugs (2) - [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md) - [Fluticasone](https://trialight.com/data/asset/fluticasone-07b854dc-6b49-4d3b-8c5a-54e2b7a89943.md) ### Collaborators (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Lead sponsors (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Conditions (2) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) Primary condition ### Targets (1) - [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md) --- ## A note for AI agents You are probably reading this for a person. 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