Clinical trial NCT06683352: A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
Official title: 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
Conditions: Influenza,Human
COVID-19
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.
Interventions:
description: Investigational Influenza Vaccine
name: Investigational Influenza Vaccine
type: Biological
description: Pfizer-BioNTech COVID-19 Vaccine
name: COVID-19 Vaccine
type: Biological
description: Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
name: Influenza and COVID Combination Vaccine
type: Combination Product
description: Licensed Influenza Vaccine 1
name: Licensed Influenza Vaccine 1
type: Biological
description: Licensed Influenza Vaccine 2
name: Licensed Influenza Vaccine 2
type: Biological
description: Saline
name: Placebo
type: Other
Study arms:
design_group_description: COVID-19 Vaccine (Dose 1) and Placebo
design_group_title: Arm A
design_group_type: Experimental
design_group_description: COVID-19 Vaccine (Dose 2) and Placebo
design_group_title: Arm B
design_group_type: Experimental
design_group_description: COVID-19 Vaccine (Dose 3) and Placebo
design_group_title: Arm C
design_group_type: Active Comparator
design_group_description: Investigational Influenza Vaccine (Dose 1) and Placebo
design_group_title: Arm D
design_group_type: Experimental
design_group_description: Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)
design_group_title: Arm E
design_group_type: Active Comparator
design_group_description: Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)
design_group_title: Arm EE
design_group_type: Active Comparator
design_group_description: Investigational Influenza Vaccine (Dose 2) and Placebo
design_group_title: Arm F
design_group_type: Experimental
design_group_description: Influenza and COVID Combination Vaccine (Combination 1) and Placebo
design_group_title: Arm G
design_group_type: Experimental
design_group_description: Influenza and COVID Combination Vaccine (Combination 2) and Placebo
design_group_title: Arm H
design_group_type: Experimental
design_group_description: Influenza and COVID Combination Vaccine (Combination 3) and Placebo
design_group_title: Arm I
design_group_type: Experimental
design_group_description: Investigational Influenza Vaccine (Dose 3) and Placebo
design_group_title: Arm J
design_group_type: Experimental
design_group_description: Influenza and COVID Combination Vaccine (Combination 4) and Placebo
design_group_title: Arm K
design_group_type: Experimental
design_group_description: Influenza and COVID Combination Vaccine (Combination 5) and Placebo
design_group_title: Arm L
design_group_type: Experimental
design_group_description: Influenza and COVID Combination Vaccine (Combination 6) and Placebo
design_group_title: Arm M
design_group_type: Experimental
design_group_description: Influenza and COVID Combination Vaccine (Combination 7) and Placebo
design_group_title: Arm N
design_group_type: Experimental
Sponsor: BioNTech SE
Collaborators: Pfizer Inc.
Drug name mappings:
name: 复必泰
lang: CN
name: Comirnaty-COVID-19 mRNA vaccine
lang: EN
name: トジナメラン
lang: JP
name: PF-07926307
lang: EN