A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- BioNTech SE
- Enrollment
- 1,353
- Locations
- 22
- Primary Endpoint
- Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 judgment of the investigator to be eligible for inclusion in the study.
Exclusion Criteria
- •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.
Arms & Interventions
Arm N
Influenza and COVID Combination Vaccine (Combination 7) and Placebo
Intervention: Placebo (Other)
Arm A
COVID-19 Vaccine (Dose 1) and Placebo
Intervention: COVID-19 Vaccine (Biological)
Arm A
COVID-19 Vaccine (Dose 1) and Placebo
Intervention: Placebo (Other)
Arm B
COVID-19 Vaccine (Dose 2) and Placebo
Intervention: COVID-19 Vaccine (Biological)
Arm B
COVID-19 Vaccine (Dose 2) and Placebo
Intervention: Placebo (Other)
Arm C
COVID-19 Vaccine (Dose 3) and Placebo
Intervention: COVID-19 Vaccine (Biological)
Arm C
COVID-19 Vaccine (Dose 3) and Placebo
Intervention: Placebo (Other)
Arm D
Investigational Influenza Vaccine (Dose 1) and Placebo
Intervention: Investigational Influenza Vaccine (Biological)
Arm D
Investigational Influenza Vaccine (Dose 1) and Placebo
Intervention: Placebo (Other)
Arm E
Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)
Intervention: COVID-19 Vaccine (Biological)
Arm E
Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)
Intervention: Licensed Influenza Vaccine 1 (Biological)
Arm EE
Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)
Intervention: COVID-19 Vaccine (Biological)
Arm EE
Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)
Intervention: Licensed Influenza Vaccine 2 (Biological)
Arm F
Investigational Influenza Vaccine (Dose 2) and Placebo
Intervention: Investigational Influenza Vaccine (Biological)
Arm F
Investigational Influenza Vaccine (Dose 2) and Placebo
Intervention: Placebo (Other)
Arm G
Influenza and COVID Combination Vaccine (Combination 1) and Placebo
Intervention: Influenza and COVID Combination Vaccine (Combination Product)
Arm G
Influenza and COVID Combination Vaccine (Combination 1) and Placebo
Intervention: Placebo (Other)
Arm H
Influenza and COVID Combination Vaccine (Combination 2) and Placebo
Intervention: Influenza and COVID Combination Vaccine (Combination Product)
Arm H
Influenza and COVID Combination Vaccine (Combination 2) and Placebo
Intervention: Placebo (Other)
Arm I
Influenza and COVID Combination Vaccine (Combination 3) and Placebo
Intervention: Influenza and COVID Combination Vaccine (Combination Product)
Arm I
Influenza and COVID Combination Vaccine (Combination 3) and Placebo
Intervention: Placebo (Other)
Arm J
Investigational Influenza Vaccine (Dose 3) and Placebo
Intervention: Investigational Influenza Vaccine (Biological)
Arm J
Investigational Influenza Vaccine (Dose 3) and Placebo
Intervention: Placebo (Other)
Arm K
Influenza and COVID Combination Vaccine (Combination 4) and Placebo
Intervention: Influenza and COVID Combination Vaccine (Combination Product)
Arm K
Influenza and COVID Combination Vaccine (Combination 4) and Placebo
Intervention: Placebo (Other)
Arm L
Influenza and COVID Combination Vaccine (Combination 5) and Placebo
Intervention: Influenza and COVID Combination Vaccine (Combination Product)
Arm L
Influenza and COVID Combination Vaccine (Combination 5) and Placebo
Intervention: Placebo (Other)
Arm M
Influenza and COVID Combination Vaccine (Combination 6) and Placebo
Intervention: Influenza and COVID Combination Vaccine (Combination Product)
Arm M
Influenza and COVID Combination Vaccine (Combination 6) and Placebo
Intervention: Placebo (Other)
Arm N
Influenza and COVID Combination Vaccine (Combination 7) and Placebo
Intervention: Influenza and COVID Combination Vaccine (Combination Product)
Outcomes
Primary Outcomes
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Time Frame: Day 7
Describe prompted local reactions following investigational product administration
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Time Frame: Day 7
Describe prompted systemic events following investigational product administration
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
Time Frame: 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
Time Frame: 6 months after vaccination
Describe SAEs through 6 months following administration of investigational product
Secondary Outcomes
No secondary outcomes reported