A PHASE 1/2 RANDOMIZED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Combination product, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
California
Anaheim Clinical Trials, LLC
RECRUITING
Anaheim
Orange County Research Center
RECRUITING
Lake Forest
Artemis Institute for Clinical Research
RECRUITING
Riverside
Artemis Institute for Clinical Research
RECRUITING
San Diego
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Connecticut
Clinical Research Consulting
RECRUITING
Milford
Florida
Alliance for Multispecialty Research, LLC
RECRUITING
Coral Gables
Indago Research & Health Center, Inc
RECRUITING
Hialeah
Miami Dade Medical Research Institute, LLC
RECRUITING
Miami
Palm Springs Community Health Center
RECRUITING
Miami Lakes
Georgia
Clinical Research Atlanta
RECRUITING
Stockbridge
Hawaii
East-West Medical Research Institute
RECRUITING
Honolulu
Missouri
Clinical Research Professionals
RECRUITING
Chesterfield
North Carolina
Trial Management Associates - Wilmington - Floral Parkway
RECRUITING
Wilmington
Nevada
Las Vegas Clinical Trials
RECRUITING
North Las Vegas
New York
Upstate Global Health Institute
RECRUITING
East Syracuse
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
Centricity Research Columbus Ohio Multispecialty
RECRUITING
Columbus
Pennsylvania
DM Clinical Research - Philadelphia
RECRUITING
Philadelphia
South Carolina
Coastal Carolina Research Center
RECRUITING
North Charleston
Tennessee
AMR Clinical
RECRUITING
Knoxville
AMR Clinical
RECRUITING
Knoxville
Clinical Research Associates Inc
RECRUITING
Nashville
Texas
Headlands Horizons, LLC dba Headlands Research-Brownsville
RECRUITING
Brownsville
DM Clinical Research- Cyfair
RECRUITING
Houston
SMS Clinical Research
RECRUITING
Mesquite
Dynamed Clinical Research, LP d/b/a DM Clinical Research
RECRUITING
Tomball
Utah
J. Lewis Research, Inc. / Foothill Family Clinic
RECRUITING
Salt Lake City
J. Lewis Research, Inc. / Foothill Family Clinic South
RECRUITING
Salt Lake City
Virginia
Charlottesville Medical Research
RECRUITING
Charlottesville
Washington
Kaiser Permanente Washington Health Research Institute (KPWHRI)
RECRUITING
Seattle
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2025-12-22
Participants
Target number of participants: 2645
Treatments
Experimental: Arm A
Low Dose COVID-19 Vaccine (1a)
Experimental: Arm B
Low Dose COVID-19 Vaccine ( 1b)
Experimental: Arm C
Low Dose COVID-19 Vaccine ( 1c)
Experimental: Arm D
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1)
Experimental: Arm E
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Experimental: Arm F
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Experimental: Arm G
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Active_comparator: Arm H
Licensed COVID-19 Vaccine
Active_comparator: Arm I
Licensed Influenza Vaccine (1)
Experimental: Arm J
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
Experimental: Arm K
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
Experimental: Arm L
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Active_comparator: Arm M
Licensed COVID-19 Vaccine
Active_comparator: Arm N
Licensed Influenza Vaccine (2)
Experimental: Arm AA
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6)
Experimental: Arm BB
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Experimental: Arm CC
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Experimental: Arm DD
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Experimental: Arm EE
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Active_comparator: Arm FF
Licensed COVID-19 Vaccine
Active_comparator: Arm GG
Licensed Influenza Vaccine (3)
Active_comparator: Arm HH
Licensed Influenza Vaccine (2)
Experimental: Arm II
Low Dose COVID-19 Vaccine ( 1b)
Experimental: Arm JJ
Low Dose COVID-19 Vaccine ( 1c)
Experimental: Arm KK
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4)
Experimental: Arm LL
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7)
Experimental: Arm MM
Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2)
Experimental: Arm NN
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3)
Experimental: Arm OO
Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5)
Experimental: Arm PP
Medium Dose Investigational Influenza Vaccine (1)
Experimental: Arm QQ
High Dose Investigational Influenza Vaccine (2)
Active_comparator: Arm RR
Licensed COVID-19 Vaccine
Active_comparator: Arm SS
Licensed Influenza Vaccine (3)
Sponsors
Collaborators: Pfizer
Leads: BioNTech SE