Clinical trial NCT06178991: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
Official title: A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
COVID-19
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2023-12-21
Enrollment: 8798
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance.

Cohort 1: Approximately 450 participants will be assigned by chance to one of the following:

* Group A:Influenza and COVID-19 combination A vaccine, given at the same time in one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm.
* Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm.

Cohort 2: Approximately 4500 participants will be assigned by chance to one of the following:

* Group C: Influenza and COVID-19 combination B vaccine, given at the same time in one arm and placebo in the opposite arm.
* Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm.

Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:

* Group E: Influenza and COVID-19 combination B vaccine.
* Group F: COVID-19 vaccine.
* Group G: Licenced influenza vaccine.
* Group H: Investigational influenza vaccine.

All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. This will help understand if the study medicine is safe.


Eligibility criteria: Inclusion Criteria:

* Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1.
* Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria:

* Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
* Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration.

Please refer to the study contact for further eligibility details

Primary outcomes:
measure: Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
timeFrame: Day 7
measure: Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
timeFrame: Day 7
measure: Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
timeFrame: 4 weeks after vaccination
measure: Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
timeFrame: 6 months after vaccination
measure: GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination
timeFrame: 4 weeks after vaccination
measure: The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients
timeFrame: 4 weeks after vaccination
measure: GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination
timeFrame: 4 weeks after vaccination
measure: The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to subjects having received licensed influenza vaccine concurrently with COVID-19
timeFrame: 4 weeks after vaccination
Secondary outcomes:
measure: GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine alone
timeFrame: 4 weeks after vaccination
measure: GMR of SARS-CoV-2-neutralizing titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received COVID-19 vaccine alone
timeFrame: 4 weeks after vaccination
measure: GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received investigational influenza vaccine alone
timeFrame: 4 weeks after vaccination
measure: GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine concomitantly with COVID-19 vaccine
timeFrame: 4 weeks after vaccination
measure: Difference in percentage of participants with seroconversion at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to licensed influenza vaccine administered concomitantly with COVID-19 vaccine recipients
timeFrame: 4 weeks after vaccination
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Sites - Birmingham Clinical Research Unit
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center/ CCT Research
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center For Clinical Research
state: Arkansas
city: Banning
country: United States
facility: Velocity Clinical Research, Banning
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Dublin
country: United States
facility: West Coast Research
state: California
city: Fullerton
country: United States
facility: Ascada Health PC dba Ascada Research
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: Pasadena
country: United States
facility: Pasadena Clinical Trials - South Arroyo Parkway
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Optimal Research San Diego
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Valley Village
country: United States
facility: Bayview Research Group, LLC
state: California
city: Vista
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research,LLC
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research,Inc.
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Gerardo Polanco, MD
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners LLC, dba Flourish Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research USA
state: Florida
city: Port Orange
country: United States
facility: United Medical Research
state: Florida
city: Tampa
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US, Inc.
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Georgia Multispecialty
state: Georgia
city: Lawrenceville
country: United States
facility: Tekton Research, LLC.
state: Georgia
city: Sandy Springs
country: United States
facility: AGILE Clinical Research Trials, LLC
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research, Boise
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc.
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Gurnee
country: United States
facility: Great Lakes Clinical Trials - Gurnee
state: Illinois
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Health
state: Illinois
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City
state: Iowa
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Baltimore
country: United States
facility: Pharmaron
state: Maryland
city: Rockville
country: United States
facility: Advanced Primary and Geriatric Care - CCT Research
state: Maryland
city: Silver Spring
country: United States
facility: Jadestone Clinical Research
state: Maryland
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research (MICHMER)
state: Michigan
city: Southfield
country: United States
facility: Headlands Research - Detroit
state: Michigan
city: Sterling Heights
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Center for Vaccine Development
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Springfield
country: United States
facility: DelRicht Research - Springfield
state: Missouri
city: Springfield
country: United States
facility: DelRicht Research
state: Missouri
city: Grand Island
country: United States
facility: Velocity Clinical Research, Grand Island
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Papillion
country: United States
facility: McGill Family Practice
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Wr-Crcn, Llc
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, LLC.
state: New Hampshire
city: Warren
country: United States
facility: IMA Clinical Research Warren
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Durham
country: United States
facility: Duke Vaccine and Trials Unit
state: North Carolina
city: Hickory
country: United States
facility: Accellacare - Hickory
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Rocky Mount
country: United States
facility: Accellacare - Rocky Mount
state: North Carolina
city: Salisbury
country: United States
facility: Accellacare - Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates - Wilmington - Floral Parkway
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare - Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Cincinnati, Mt. Auburn
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Mt. Auburn
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US, Inc.
state: Ohio
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Little River
country: United States
facility: Main Street Physician's Care
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates, LLC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare US Inc., d/b/a Accellacare of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: Austin
country: United States
facility: Tekton Research, LLC.
state: Texas
city: Austin
country: United States
facility: Orion Clinical Research
state: Texas
city: Brownsville
country: United States
facility: Headlands Horizons, LLC dba Headlands Research-Brownsville
state: Texas
city: Carrollton
country: United States
facility: ACRC TRIALS / Family Medicine Associates of Texas
state: Texas
city: Dallas
country: United States
facility: DFW Clinical Research
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Dallas
country: United States
facility: DFW Clinical Research
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Family Care
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Houston
country: United States
facility: Santa Clara Family Clinic
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials (Administrative Location)
state: Texas
city: Plano
country: United States
facility: ACRC TRIALS / North Texas Family Medicine
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC dba Flourish Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice, PA
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - MDC
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: