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

Purpose

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)

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants 18 years of age or older - 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

  • Vaccination with any investigational or licensed influenza vaccine within 150 days of enrollment - Vaccination with any investigational or licensed COVID 19 vaccine within 150 days of enrollment. - Receipt of antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1. Refer to the study contact for further eligibility details

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Low Dose COVID-19 Vaccine (1a)
  • Biological: Investigational COVID-19 Vaccine
    Investigational COVID-19 Vaccine
Experimental
Arm B 		Low Dose COVID-19 Vaccine ( 1b)
  • Biological: Investigational COVID-19 Vaccine
    Investigational COVID-19 Vaccine
Experimental
Arm C 		Low Dose COVID-19 Vaccine ( 1c)
  • Biological: Investigational COVID-19 Vaccine
    Investigational COVID-19 Vaccine
Experimental
Arm D 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm E 		Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm F 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm G 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator
Arm H 		Low Dose Licensed COVID-19 Vaccine
  • Biological: Licensed COVID-19 Vaccine
    Pfizer-BioNTech COVID-19 Vaccine
Active Comparator
Arm I 		Licensed Influenza Vaccine (1)
  • Biological: Licensed Influenza Vaccine 1
    Licensed Influenza Vaccine 1
Experimental
Arm AA 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm BB 		Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm CC 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm DD 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Active Comparator
Arm EE 		Low Dose Licensed COVID-19 Vaccine
  • Biological: Licensed COVID-19 Vaccine
    Pfizer-BioNTech COVID-19 Vaccine
Active Comparator
Arm FF 		Licensed Influenza Vaccine (2)
  • Biological: Licensed Influenza Vaccine 2
    Licensed Influenza Vaccine 2
Experimental
Arm GG 		Low Dose COVID-19 Vaccine (1a)
  • Biological: Investigational COVID-19 Vaccine
    Investigational COVID-19 Vaccine
Experimental
Arm HH 		Low Dose COVID-19 Vaccine (1b)
  • Biological: Investigational COVID-19 Vaccine
    Investigational COVID-19 Vaccine
Experimental
Arm II 		Low Dose COVID-19 Vaccine (1c)
  • Biological: Investigational COVID-19 Vaccine
    Investigational COVID-19 Vaccine
Experimental
Arm JJ 		Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 5)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm KK 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm LL 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm MM 		Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 8)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm NN 		Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 9)
  • Combination Product: Investigational Influenza and COVID-19 Combination Vaccine
    Investigational Combined Influenza and COVID-19 Vaccine
Experimental
Arm OO 		Medium Dose Investigational Influenza Vaccine (1a)
  • Biological: Investigational Influenza Vaccine
    Investigational Influenza Vaccine
Experimental
Arm PP 		Medium Dose Investigational Influenza Vaccine (1b)
  • Biological: Investigational Influenza Vaccine
    Investigational Influenza Vaccine
Experimental
Arm QQ 		Low Dose Investigational Influenza Vaccine (2a)
  • Biological: Investigational Influenza Vaccine
    Investigational Influenza Vaccine
Experimental
Arm RR 		Medium Dose Investigational Influenza Vaccine (2b)
  • Biological: Investigational Influenza Vaccine
    Investigational Influenza Vaccine
Active Comparator
Arm SS 		Low Dose Licensed COVID-19 Vaccine
  • Biological: Licensed COVID-19 Vaccine
    Pfizer-BioNTech COVID-19 Vaccine
Active Comparator
Arm TT 		Licensed Influenza Vaccine (2)
  • Biological: Licensed Influenza Vaccine 2
    Licensed Influenza Vaccine 2
Active Comparator
Arm UU 		Licensed Influenza Vaccine (3)
  • Biological: Licensed Influenza Vaccine 3
    Licensed Influenza Vaccine 3

Recruiting Locations

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Clinical Research Consulting
Milford, Connecticut 06460

East-West Medical Research Institute
Honolulu, Hawaii 96814

Las Vegas Clinical Trials
North Las Vegas, Nevada 89030

DM Clinical Research- Cyfair
Houston, Texas 77065

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84109

J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah 84121

Charlottesville Medical Research
Charlottesville, Virginia 22911

More Details

NCT ID
NCT06821061
Status
Recruiting
Sponsor
BioNTech SE

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com