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OpenTrials
Completed

NCT Number: NCT06821061

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

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.

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Key information

Conditions

Influenza COVID-19 COVID-19 (Coronavirus Disease 2019) 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

Anaheim Clinical Trials, LLC, Anaheim, 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 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

Treatment and study plan

Investigational Influenza Vaccine

Biological

Investigational Influenza Vaccine

Investigational COVID-19 Vaccine

Biological

Investigational COVID-19 Vaccine

Investigational Influenza and COVID-19 Combination Vaccine

Combination Product

Investigational Combined Influenza and COVID-19 Vaccine

Licensed Influenza Vaccine 1

Biological

Licensed Influenza Vaccine 1

Licensed Influenza Vaccine 2

Biological

Licensed Influenza Vaccine 2

Licensed Influenza Vaccine 3

Biological

Licensed Influenza Vaccine 3

Licensed COVID-19 Vaccine

Biological

Pfizer-BioNTech COVID-19 Vaccine

Primary outcomes

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

    Time frame: Day 7

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

    Time frame: Day 7

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

    Time frame: 1 month

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

    Time frame: 6 months

Secondary outcomes

  1. GMTs before and through 1 month following investigational product administration

    Time frame: Before vaccination through to 1 month after vaccination

Sponsors and collaborators

Lead sponsor

BioNTech SE

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Jan 26, 2026

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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