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OpenTrials
Completed

NCT Number: NCT06683352

A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People

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.

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Key information

Conditions

Influenza,Human COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Orange County Research Center, Lake Forest, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational Influenza Vaccine

Biological

Investigational Influenza Vaccine

COVID-19 vaccine

Biological

Pfizer-BioNTech COVID-19 Vaccine

Influenza and COVID Combination Vaccine

Combination Product

Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine

Licensed Influenza Vaccine 1

Biological

Licensed Influenza Vaccine 1

Licensed Influenza Vaccine 2

Biological

Licensed Influenza Vaccine 2

Placebo

Other

Saline

Primary outcomes

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

    Time frame: Day 7

    Describe prompted local reactions following investigational product administration

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

    Time frame: Day 7

    Describe prompted systemic events following investigational product administration

  3. Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration

    Time frame: 4 weeks after vaccination

    Describe AEs occurring through 4 weeks following administration of investigational product

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

    Time frame: 6 months after vaccination

    Describe SAEs through 6 months following administration of investigational product

Sponsors and collaborators

Lead sponsor

BioNTech SE

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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