Clinical trial NCT06683352: A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Influenza,Human
COVID-19
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2024-11-12
Enrollment: 1353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

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
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
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: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
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: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC dba QPS-MO
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
state: Missouri
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: 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: Houston
country: United States
facility: DM Clinical Research- Cyfair
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
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: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: