Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
Lead Sponsor:
BioNTech SE
Collaborating Sponsors:
Pfizer
Conditions:
Influenza
COVID-19
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influe...
Eligibility Criteria
Inclusion
- Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1.
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion
- Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
- Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration.
- Please refer to the study contact for further eligibility details
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2024
Estimated Enrollment :
8795 Patients enrolled
Trial Details
Trial ID
NCT06178991
Start Date
December 20 2023
End Date
November 26 2024
Last Update
December 4 2025
Active Locations (106)
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1
North Alabama Research Center
Athens, Alabama, United States, 35611
2
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States, 35216
3
AMR Clinical
Mobile, Alabama, United States, 36608
4
HOPE Research Institute
Phoenix, Arizona, United States, 85032