A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People

BioNTech SE2,650 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,650

Conditions

Influenza COVID-19 (Coronavirus Disease 2019)

Interventions

Investigational Influenza VaccineBIOLOGICAL

Investigational Influenza Vaccine

Investigational COVID-19 VaccineBIOLOGICAL

Investigational COVID-19 Vaccine

Investigational Influenza and COVID-19 Combination VaccineCOMBINATION_PRODUCT

Investigational Combined Influenza and COVID-19 Vaccine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (31)

Outcomes

Primary Outcomes

Percentage of participants reporting prompted local reactions within 7 days following investigational product administration

Time frame: Day 7

Percentage of participants reporting prompted systemic events within 7 days following investigational product administration

Time frame: Day 7

Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration

Time frame: 1 month

Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration

Time frame: 6 months

Secondary Outcomes

GMTs before and through 1 month following investigational product administration

Time frame: Before vaccination through to 1 month after vaccination

Data from ClinicalTrials.gov

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Lake Forest, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

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Milford, Connecticut, United States

Alliance for Multispecialty Research, LLC

Doral, Florida, United States

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Palm Springs Community Health Center

Miami Lakes, Florida, United States

...and 21 more locations