Flu and COVID-19 Vaccines for Virus Protection

Recruiting at21 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: BioNTech SE

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Healthy individuals aged 18 or older are eligible for this study, which examines responses to flu and COVID-19 vaccines. Participants will receive shots in both arms and must commit to at least three visits over six months.

Inclusion Criteria

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.

I am 18 years old or older.

Exclusion Criteria

I have taken antiviral medication for the flu in the last 6 months.

I have received a flu or COVID-19 vaccine for the 2024-2025 season.

Treatment Details

Interventions

• COVID-19 Vaccine (Virus Therapy)
• Influenza and COVID Combination Vaccine (Virus Therapy)
• Investigational Influenza Vaccine (Virus Therapy)
• Licensed Influenza Vaccine 1 (Virus Therapy)
• Licensed Influenza Vaccine 2 (Virus Therapy)

Trial Overview The trial is testing how people respond to different combinations of flu and COVID-19 vaccines. This includes licensed influenza vaccines, an investigational influenza vaccine, a combination vaccine, a standalone COVID-19 vaccine, and placebos.

Participant Groups

Group I: Arm N Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 7) and Placebo

Group II: Arm M Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 6) and Placebo

Group III: Arm L Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 5) and Placebo

Group IV: Arm K Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 4) and Placebo

Group V: Arm J Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 3) and Placebo

Group VI: Arm I Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 3) and Placebo

Group VII: Arm H Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 2) and Placebo

Group VIII: Arm G Experimental Treatment 2 Interventions

Influenza and COVID Combination Vaccine (Combination 1) and Placebo

Group IX: Arm F Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 2) and Placebo

Group X: Arm D Experimental Treatment 2 Interventions

Investigational Influenza Vaccine (Dose 1) and Placebo

Group XI: Arm B Experimental Treatment 2 Interventions

COVID-19 Vaccine (Dose 2) and Placebo

Group XII: Arm A Experimental Treatment 2 Interventions

COVID-19 Vaccine (Dose 1) and Placebo

Group XIII: Arm C Active Control 2 Interventions

COVID-19 Vaccine (Dose 3) and Placebo

Group XIV: Arm E Active Control 2 Interventions

Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)

Group XV: Arm EE Active Control 2 Interventions

Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University