Skip to main content
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.

Completed

Looking for future studies?

Notify Me

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

Investigational Influenza/COVID-19 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. Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination

    Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

    Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.

  2. Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination

    Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

    Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.

  3. Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination

    Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

    Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.

  4. Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination

    Time frame: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]

    Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.

  5. Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination

    Time frame: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

  6. Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination

    Time frame: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.

  7. Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination

    Time frame: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]

    SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.

  8. Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination

    Time frame: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]

    SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.

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 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.