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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06178991
Recruitment Status : Recruiting
First Posted : December 21, 2023
Last Update Posted : April 18, 2024
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Study Description
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Brief Summary:

The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2. Influenza and COVID-19 are diseases that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. Giving both influenza and COVID-19 vaccines together against influenza and SARS-CoV-2 could provide great benefits to both patients and caregivers in terms of simple and easy care. Around 9000 participants will be assigned into 1 of 4 vaccination groups (Group A, B, C or D) by chance.

Cohort 1: Around 4500 participants will be assigned by chance to one of the following:

  • Group A:Influenza and COVID-19 combination A vaccine, given at the same time in the right arm and placebo (an injection consisting of just salt water and no medicines in it) in the left arm.
  • Group B: COVID-19 vaccine, given at the same time to the right arm and licensed influenza vaccine in the left arm.

Cohort 2: Around 4500 participants will be assigned by chance to one of the following:

  • Group C: Influenza and COVID-19 combination B vaccine, given at the same time in the right arm and placebo in the left arm.
  • Group D: COVID-19 vaccine, given at the same time in the right arm and licenced influenza vaccine in the left arm.

All participants will receive 2 injections as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, the study will compare participant experiences when they receive a combined vaccination to when they receive separate vaccinations. This will help understand if the study medicine is safe.


Condition or disease Intervention/treatment Phase
Influenza COVID-19 Biological: Influenza and COVID-19 Combination A Biological: Licensed influenza vaccine Biological: COVID-19 Vaccine Biological: Influenza and COVID-19 Combination B Biological: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : December 5, 2024
Estimated Study Completion Date : December 5, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo
Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
 Biological: Influenza and COVID-19 Combination A
Combined influenza and Pfizer-BioNTech COVID-19 Vaccine

Biological: Placebo
Saline Solution
Active Comparator: Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
 Biological: Licensed influenza vaccine
Licensed influenza vaccine

Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine
Experimental: Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo
Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
 Biological: Influenza and COVID-19 Combination B
Combined influenza and Pfizer-BioNTech COVID-19 vaccine

Biological: Placebo
Saline Solution
Active Comparator: Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
 Biological: Licensed influenza vaccine
Licensed influenza vaccine

Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants reporting prompted local reactions within 7 days following investigational product administration in the right deltoid [ 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

  5. GMR of HAI titers in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by licensed influenza vaccine and COVID-19 concomitant administration group

  6. The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to licensed influenza vaccine recipients [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by Licensed influenza vaccine and COVID-19 concomitant administration group.

  7. GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination A recipients compared to participants having received licensed influenza vaccine and COVID-19 concomitant administration group at 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine

  8. The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in Influenza and COVID-19 combination A recipients compared to subjects having received licensed influenza vaccine and COVID-19 concomitant administration group [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination A is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine

  9. GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19

  10. The difference in percentage of participants achieving seroconversion at 4 weeks after vaccination in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by licensed influenza vaccine administered concomitantly with COVID-19

  11. GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine

  12. The difference in percentages of subjects with seroresponse at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to subjects having received licensed influenza vaccine concurrently with COVID-19 [ Time Frame: 4 weeks after vaccination ]
    To demonstrate that the immune response elicited by Influenza and COVID-19 combination B is noninferior to that elicited by COVID-19 administered concomitantly with licensed influenza vaccine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

Exclusion Criteria:

  • Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
  • Vaccination with any investigational or licensed COVID-19 vaccine within 6 months (175 days) before study intervention administration.

Please refer to the study contact for further eligibility details

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06178991


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT06178991    
Other Study ID Numbers: C5261002
First Posted: December 21, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Influenza, Human
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Orthomyxoviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs