CD2H COVID-19

A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People

Purpose

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.

Conditions

Influenza,Human
COVID-19

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 judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria

Vaccination with any investigational or licensed 2024-2025 season formulation influenza or COVID-19 vaccine. - Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1 Please 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

Arm	Description	Assigned Intervention
Experimental Arm A	COVID-19 Vaccine (Dose 1) and Placebo	Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm B	COVID-19 Vaccine (Dose 2) and Placebo	Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Active Comparator Arm C	COVID-19 Vaccine (Dose 3) and Placebo	Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm D	Investigational Influenza Vaccine (Dose 1) and Placebo	Biological: Investigational Influenza Vaccine Investigational Influenza Vaccine Other: Placebo Saline
Active Comparator Arm E	Licensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)	Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine Biological: Licensed Influenza Vaccine 1 Licensed Influenza Vaccine 1 Biological: Licensed Influenza Vaccine 2 Licensed Influenza Vaccine 2
Active Comparator Arm EE	Licensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)	Biological: COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine Biological: Licensed Influenza Vaccine 2 Licensed Influenza Vaccine 2
Experimental Arm F	Investigational Influenza Vaccine (Dose 2) and Placebo	Biological: Investigational Influenza Vaccine Investigational Influenza Vaccine Other: Placebo Saline
Experimental Arm G	Influenza and COVID Combination Vaccine (Combination 1) and Placebo	Combination Product: Influenza and COVID Combination Vaccine Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm H	Influenza and COVID Combination Vaccine (Combination 2) and Placebo	Combination Product: Influenza and COVID Combination Vaccine Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm I	Influenza and COVID Combination Vaccine (Combination 3) and Placebo	Combination Product: Influenza and COVID Combination Vaccine Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm J	Investigational Influenza Vaccine (Dose 3) and Placebo	Biological: Investigational Influenza Vaccine Investigational Influenza Vaccine Other: Placebo Saline
Experimental Arm K	Influenza and COVID Combination Vaccine (Combination 4) and Placebo	Combination Product: Influenza and COVID Combination Vaccine Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm L	Influenza and COVID Combination Vaccine (Combination 5) and Placebo	Combination Product: Influenza and COVID Combination Vaccine Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm M	Influenza and COVID Combination Vaccine (Combination 6) and Placebo	Combination Product: Influenza and COVID Combination Vaccine Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline
Experimental Arm N	Influenza and COVID Combination Vaccine (Combination 7) and Placebo	Combination Product: Influenza and COVID Combination Vaccine Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine Other: Placebo Saline

Recruiting Locations

More Details

NCT ID: NCT06683352
Status: Not yet recruiting
Sponsor: BioNTech SE

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.