Clinical trial NCT06821061: A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Influenza
COVID-19 (Coronavirus Disease 2019)
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2025-02-11
Enrollment: 2050
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: 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 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 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

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 1 month following investigational product administration
timeFrame: 1 month
measure: Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration
timeFrame: 6 months
Secondary outcomes:
measure: GMTs before and through 1 month following investigational product administration
timeFrame: Before vaccination through to 1 month after vaccination
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
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: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
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: 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: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Wilmington
country: United States
facility: Trial Management Associates - Wilmington - Floral Parkway
state: North Carolina
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Brownsville
country: United States
facility: Headlands Horizons, LLC dba Headlands Research-Brownsville
state: Texas
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: