NCT06821061

A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2,650 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• COVID-19 (Coronavirus Disease 2019)

Interventions

Type	Name	Description
BIOLOGICAL	Investigational Influenza Vaccine	Investigational Influenza Vaccine
BIOLOGICAL	Investigational COVID-19 Vaccine	Investigational COVID-19 Vaccine
COMBINATION_PRODUCT	Investigational Influenza and COVID-19 Combination Vaccine	Investigational Combined Influenza and COVID-19 Vaccine
BIOLOGICAL	Licensed Influenza Vaccine 1	Licensed Influenza Vaccine 1
BIOLOGICAL	Licensed Influenza Vaccine 2	Licensed Influenza Vaccine 2
BIOLOGICAL	Licensed Influenza Vaccine 3	Licensed Influenza Vaccine 3
BIOLOGICAL	Licensed COVID-19 Vaccine	Pfizer-BioNTech COVID-19 Vaccine

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-12-17
• Completion: 2025-12-17
• First posted: 2025-02-11
• Last updated: 2026-01-26

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study