> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-a-covid-19-vaccine-in-healthy-adults-9c35986f-ab6e-41ab-99b4-71851358999b > Record changed: 2026-10-13 # A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age NCT07300839 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) Participants 5,240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) Lead sponsor BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) Start date 2025-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) Number of sites 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Title and summary **Summary** This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect against COVID-19 (placebo). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Short title** A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Official title** A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY AND EFFICACY OF A VARIANT-ADAPTED BNT162B2 VACCINE IN HEALTHY PARTICIPANTS 50 THROUGH 64 YEARS OF AGE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Dates **Completion date** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **First posted** 2025-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Registry last updated** 2026-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Primary completion date** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Start date** 2025-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Size and sites **Actual participants** 5,240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Participants** 5,240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Number of sites** 196 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Lead sponsor** BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Identifiers **Registry ID** NCT07300839 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **ClinicalTrials.gov ID** NCT07300839 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## 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/NCT07300839) ## Outcomes ### Primary outcomes 1. Percentage of participants reporting local reactions or systemic events Timeframe: From Day 1 up to 7 days after Vaccination 2. Percentage of participants reporting adverse events Timeframe: From Day 1 through 4 weeks after vaccination 3. Percentage of participants reporting serious adverse events Timeframe: From Day 1 through 6 months after vaccination 4. First episode of confirmed COVID-19 cases Timeframe: From 0 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination ### Secondary outcomes 1. First episode of confirmed COVID-19 cases Timeframe: From 7 days after vaccination through end of COVID-19 surveillance at least 6 months post-vaccination 2. Geometric Mean Ratio (GMR) Timeframe: From before vaccination to 1 month after vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 50 Years **Maximum age** 64 Years **Healthy volunteers** Yes Key Inclusion Criteria - People who are between 50 and 64 years old at their first appointment. - People who are healthy and, based on their medical history and a doctor's judgment, are considered suitable to join the study. Key Exclusion Criteria - People who had COVID-19 in the past 3 months (90 days) before their first visit. - People who got a COVID-19 vaccine, either as part of a research study or an approved vaccine, in the last 3 months-or plans to get one during the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Sites - Pinnacle Research Group, LLCAnniston, United States - North Alabama Research CenterAthens, United States - Simon Williamson Clinic / Synexus Clinical Research US, Inc.Birmingham, United States - Accel Research Sites - Birmingham Clinical Research UnitBirmingham, United States - Cullman Clinical TrialsCullman, United States - AMR ClinicalDaphne, United States - Medical Affiliated Research CenterHuntsville, United States - AMR ClinicalMobile, United States - Chandler Clinical TrialsChandler, United States - Scottsdale Clinical TrialsScottsdale, United States - Epic Medical Research-Sun CitySun City, United States - Noble Clinical ResearchTucson, United States - Synexus Clinical Research US, Inc./Orange Grove Family PracticeTucson, United States - Woodland International Research Group, LLCLittle Rock, United States - Anaheim Clinical Trials, LLCAnaheim, United States - Velocity Clinical Research, Chula VistaChula Vista, United States - West Coast ResearchDublin, United States - Triallogix Medical CorporationFullerton, United States - Upper Echelon MedicalFullerton, United States - Marvel Clinical ResearchHuntington Beach, United States - Eximia Research-CA, LLCLa Mesa, United States - Velocity Clinical Research, Los AngelesLos Angeles, United States - Leading Edge ResearchLos Angeles, United States - ImmuniMetModesto, United States - Carbon Health - North Hollywood - NoHo WestNorth Hollywood, United States And 171 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4591081) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07300839) ## Related records ### Drugs (1) - [Tozinameran](https://trialight.com/data/asset/tozinameran-bb0e4f65-bf06-4152-bd75-c7c1f5505a9d.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 (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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