Flu and COVID-19 Vaccines for Coronavirus and Influenza

Recruiting at 29 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioNTech SE

Must not be taking: Antivirals

Disqualifiers: Recent flu or COVID vaccine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

2645 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Healthy individuals aged 18 or older are eligible for this study, which involves receiving a single shot of either a flu or COVID vaccine, alone or in combination. Participants will be involved for approximately 6 months and must visit the study site at least four times.

Inclusion Criteria

Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study

Exclusion Criteria

I have been vaccinated against COVID-19 within the last 150 days.

I have not had a flu vaccine in the last 150 days.

I haven't taken flu antivirals like Tamiflu in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one shot of either a flu or COVID vaccine, alone or mixed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after receiving the vaccine

6 months

At least 4 visits (in-person)

Treatment Details

Interventions

• Investigational Influenza and COVID-19 Combination Vaccine

Trial Overview The trial is testing how different vaccines (flu and COVID-19) work when given separately or together. This includes licensed influenza vaccines, an approved COVID-19 vaccine, as well as investigational flu and COVID-19 vaccines.

Participant Groups

Group I: Arm QQ Experimental Treatment 1 Intervention

High Dose Investigational Influenza Vaccine (2)

Group II: Arm PP Experimental Treatment 1 Intervention

Medium Dose Investigational Influenza Vaccine (1)

Group III: Arm OO Experimental Treatment 2 Interventions

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)

Group IV: Arm NN Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Group V: Arm MM Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Group VI: Arm LL Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)

Group VII: Arm L Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)

Group VIII: Arm KK Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Group IX: Arm K Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)

Group X: Arm JJ Experimental Treatment 2 Interventions

Low Dose COVID-19 Vaccine ( 1c)

Group XI: Arm J Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)

Group XII: Arm II Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine ( 1b)

Group XIII: Arm G Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Group XIV: Arm F Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Group XV: Arm EE Experimental Treatment 2 Interventions

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)

Group XVI: Arm E Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Group XVII: Arm DD Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)

Group XVIII: Arm D Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)

Group XIX: Arm CC Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)

Group XX: Arm C Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine ( 1c)

Group XXI: Arm BB Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)

Group XXII: Arm B Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine ( 1b)

Group XXIII: Arm AA Experimental Treatment 1 Intervention

Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)

Group XXIV: Arm A Experimental Treatment 1 Intervention

Low Dose COVID-19 Vaccine (1a)

Group XXV: Arm H Active Control 1 Intervention

Licensed COVID-19 Vaccine

Group XXVI: Arm I Active Control 1 Intervention

Licensed Influenza Vaccine (1)

Group XXVII: Arm SS Active Control 2 Interventions

Licensed Influenza Vaccine (3)

Group XXVIII: Arm GG Active Control 2 Interventions

Licensed Influenza Vaccine (3)

Group XXIX: Arm RR Active Control 2 Interventions

Licensed COVID-19 Vaccine

Group XXX: Arm FF Active Control 2 Interventions

Licensed COVID-19 Vaccine

Group XXXI: Arm HH Active Control 2 Interventions

Licensed Influenza Vaccine (2)

Group XXXII: Arm M Active Control 1 Intervention

Licensed COVID-19 Vaccine

Group XXXIII: Arm N Active Control 1 Intervention

Licensed Influenza Vaccine (2)

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