A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
1 other identifier
interventional
1,353
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2024
Shorter than P25 for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2025
CompletedAugust 15, 2025
August 1, 2025
8 months
November 8, 2024
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Describe prompted local reactions following investigational product administration
Day 7
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Describe prompted systemic events following investigational product administration
Day 7
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
Describe AEs occurring through 4 weeks following administration of investigational product
4 weeks after vaccination
Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
Describe SAEs through 6 months following administration of investigational product
6 months after vaccination
Study Arms (15)
Arm A
EXPERIMENTALCOVID-19 Vaccine (Dose 1) and Placebo
Arm B
EXPERIMENTALCOVID-19 Vaccine (Dose 2) and Placebo
Arm C
ACTIVE COMPARATORCOVID-19 Vaccine (Dose 3) and Placebo
Arm D
EXPERIMENTALInvestigational Influenza Vaccine (Dose 1) and Placebo
Arm E
ACTIVE COMPARATORLicensed Influenza Vaccine 1 and COVID-19 Vaccine (Dose 3)
Arm EE
ACTIVE COMPARATORLicensed Influenza Vaccine 2 and COVID-19 Vaccine (Dose 3)
Arm F
EXPERIMENTALInvestigational Influenza Vaccine (Dose 2) and Placebo
Arm G
EXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 1) and Placebo
Arm H
EXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 2) and Placebo
Arm I
EXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 3) and Placebo
Arm J
EXPERIMENTALInvestigational Influenza Vaccine (Dose 3) and Placebo
Arm K
EXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 4) and Placebo
Arm L
EXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 5) and Placebo
Arm M
EXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 6) and Placebo
Arm N
EXPERIMENTALInfluenza and COVID Combination Vaccine (Combination 7) and Placebo
Interventions
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
Eligibility Criteria
You may qualify if:
- Participants 18 years of age or older
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
- Pfizercollaborator
Study Sites (22)
Orange County Research Center
Lake Forest, California, 92630, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Palm Springs Community Health Center
Miami Lakes, Florida, 33014, United States
Headlands Research Orlando
Orlando, Florida, 32819, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri, 65807, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, 89030, United States
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, 03801, United States
DM Clinical Research- Cyfair
Houston, Texas, 77065, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Tomball, Texas, 77375, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2024
First Posted
November 12, 2024
Study Start
November 11, 2024
Primary Completion
July 15, 2025
Study Completion
July 15, 2025
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share