A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
- Conditions
- Influenza,HumanCOVID-19
- Interventions
- Biological: Investigational Influenza VaccineCombination Product: Influenza and COVID Combination VaccineOther: PlaceboBiological: Licensed Influenza Vaccine 1Biological: Licensed Influenza Vaccine 2
- Registration Number
- NCT06683352
- Lead Sponsor
- BioNTech SE
- Brief Summary
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1353
- Participants 18 years of age or older
- Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Vaccination with any investigational or licensed 2024-2025 season formulation influenza or COVID-19 vaccine.
- Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1
Please refer to the study contact for further eligibility details.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A COVID-19 Vaccine COVID-19 Vaccine (Dose 1) and Placebo Arm A Placebo COVID-19 Vaccine (Dose 1) and Placebo Arm B COVID-19 Vaccine COVID-19 Vaccine (Dose 2) and Placebo Arm B Placebo COVID-19 Vaccine (Dose 2) and Placebo Arm C COVID-19 Vaccine COVID-19 Vaccine (Dose 3) and Placebo Arm C Placebo COVID-19 Vaccine (Dose 3) and Placebo Arm D Investigational Influenza Vaccine Investigational Influenza Vaccine (Dose 1) and Placebo Arm D Placebo Investigational Influenza Vaccine (Dose 1) and Placebo Arm E Licensed Influenza Vaccine 1 Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3) Arm EE Licensed Influenza Vaccine 2 Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3) Arm F Investigational Influenza Vaccine Investigational Influenza Vaccine (Dose 2) and Placebo Arm F Placebo Investigational Influenza Vaccine (Dose 2) and Placebo Arm G Influenza and COVID Combination Vaccine Influenza and COVID Combination Vaccine (Combination 1) and Placebo Arm G Placebo Influenza and COVID Combination Vaccine (Combination 1) and Placebo Arm H Influenza and COVID Combination Vaccine Influenza and COVID Combination Vaccine (Combination 2) and Placebo Arm H Placebo Influenza and COVID Combination Vaccine (Combination 2) and Placebo Arm I Influenza and COVID Combination Vaccine Influenza and COVID Combination Vaccine (Combination 3) and Placebo Arm I Placebo Influenza and COVID Combination Vaccine (Combination 3) and Placebo Arm J Investigational Influenza Vaccine Investigational Influenza Vaccine (Dose 3) and Placebo Arm J Placebo Investigational Influenza Vaccine (Dose 3) and Placebo Arm K Influenza and COVID Combination Vaccine Influenza and COVID Combination Vaccine (Combination 4) and Placebo Arm K Placebo Influenza and COVID Combination Vaccine (Combination 4) and Placebo Arm L Influenza and COVID Combination Vaccine Influenza and COVID Combination Vaccine (Combination 5) and Placebo Arm L Placebo Influenza and COVID Combination Vaccine (Combination 5) and Placebo Arm M Influenza and COVID Combination Vaccine Influenza and COVID Combination Vaccine (Combination 6) and Placebo Arm M Placebo Influenza and COVID Combination Vaccine (Combination 6) and Placebo Arm N Influenza and COVID Combination Vaccine Influenza and COVID Combination Vaccine (Combination 7) and Placebo Arm N Placebo Influenza and COVID Combination Vaccine (Combination 7) and Placebo Arm E COVID-19 Vaccine Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3) Arm EE COVID-19 Vaccine Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)
- Primary Outcome Measures
Name Time Method Percentage of participants reporting prompted local reactions within 7 days following investigational product administration Day 7 Describe prompted local reactions following investigational product administration
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration Day 7 Describe prompted systemic events following investigational product administration
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration 4 weeks after vaccination Describe AEs occurring through 4 weeks following administration of investigational product
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration 6 months after vaccination Describe SAEs through 6 months following administration of investigational product
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
🇺🇸Springfield, Missouri, United States
Orange County Research Center
🇺🇸Lake Forest, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
Palm Springs Community Health Center
🇺🇸Miami Lakes, Florida, United States
Headlands Research Orlando
🇺🇸Orlando, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
🇺🇸Springfield, Missouri, United States
Velocity Clinical Research, Omaha
🇺🇸Omaha, Nebraska, United States
Las Vegas Clinical Trials
🇺🇸Las Vegas, Nevada, United States
ActivMed Practices & Research, LLC.
🇺🇸Portsmouth, New Hampshire, United States
DM Clinical Research- Cyfair
🇺🇸Houston, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
🇺🇸Tomball, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
Miami Dade Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States