CD2H COVID-19

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 Sex: 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

Arm	Description	Assigned 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	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 J	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm K	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 L	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
Active Comparator Arm M	Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine
Active Comparator Arm N	Licensed Influenza Vaccine (2)	Biological: Licensed Influenza Vaccine 2 Licensed Influenza Vaccine 2
Experimental Arm AA	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 BB	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
Experimental Arm CC	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 DD	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 EE	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
Active Comparator Arm FF	Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine
Active Comparator Arm GG	Licensed Influenza Vaccine (3)	Biological: Licensed Influenza Vaccine 3 Licensed Influenza Vaccine 3
Active Comparator Arm HH	Licensed Influenza Vaccine (2)	Biological: Licensed Influenza Vaccine 2 Licensed Influenza Vaccine 2
Experimental Arm II	Low Dose COVID-19 Vaccine ( 1b)	Biological: Investigational COVID-19 Vaccine Investigational COVID-19 Vaccine
Experimental Arm JJ	Low Dose COVID-19 Vaccine ( 1c)	Biological: Investigational COVID-19 Vaccine Investigational COVID-19 Vaccine
Experimental Arm KK	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
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 2)	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 3)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm OO	Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)	Combination Product: Investigational Influenza and COVID-19 Combination Vaccine Investigational Combined Influenza and COVID-19 Vaccine
Experimental Arm PP	Medium Dose Investigational Influenza Vaccine (1)	Biological: Investigational Influenza Vaccine Investigational Influenza Vaccine
Experimental Arm QQ	High Dose Investigational Influenza Vaccine (2)	Biological: Investigational Influenza Vaccine Investigational Influenza Vaccine
Active Comparator Arm RR	Licensed COVID-19 Vaccine	Biological: Licensed COVID-19 Vaccine Pfizer-BioNTech COVID-19 Vaccine
Active Comparator Arm SS	Licensed Influenza Vaccine (3)	Biological: Licensed Influenza Vaccine 3 Licensed Influenza Vaccine 3

Recruiting Locations

Anaheim Clinical Trials, LLC
Anaheim 5323810, California 5332921 92801

Orange County Research Center
Lake Forest 5364514, California 5332921 92630

Artemis Institute for Clinical Research
Riverside 5387877, California 5332921 92503

Artemis Institute for Clinical Research
San Diego 5391811, California 5332921 92103

Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921 94598

Clinical Research Consulting
Milford 4838652, Connecticut 4831725 06460

Alliance for Multispecialty Research, LLC
Coral Gables 4151871, Florida 4155751 33134

Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751 33012

Miami Dade Medical Research Institute, LLC
Miami 4164138, Florida 4155751 33176

Palm Springs Community Health Center
Miami Lakes 4164186, Florida 4155751 33014

Clinical Research Atlanta
Stockbridge 4224681, Georgia 4197000 30281

East-West Medical Research Institute
Honolulu 5856195, Hawaii 5855797 96814

Clinical Research Professionals
Chesterfield 4381072, Missouri 4398678 63005

Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151 89030

Upstate Global Health Institute
East Syracuse 5116079, New York 5128638 13057

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642

Trial Management Associates - Wilmington - Floral Parkway
Wilmington 4499379, North Carolina 4482348 28403

Centricity Research Columbus Ohio Multispecialty
Columbus 4509177, Ohio 5165418 43213

DM Clinical Research - Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19107

Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040 29405

AMR Clinical
Knoxville 4634946, Tennessee 4662168 37909

AMR Clinical
Knoxville 4634946, Tennessee 4662168 37920

Clinical Research Associates Inc
Nashville 4644585, Tennessee 4662168 37203

Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville 4676740, Texas 4736286 78526

DM Clinical Research- Cyfair
Houston 4699066, Texas 4736286 77065

SMS Clinical Research
Mesquite 4710826, Texas 4736286 75149

Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball 4737094, Texas 4736286 77375

J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030 84109

J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City 5780993, Utah 5549030 84121

Charlottesville Medical Research
Charlottesville 4752031, Virginia 6254928 22911

Kaiser Permanente Washington Health Research Institute (KPWHRI)
Seattle 5809844, Washington 5815135 98101

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

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.