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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06178991
Recruitment Status : Active, not recruiting
First Posted : December 21, 2023
Last Update Posted : June 6, 2024
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

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 8550 participants will be assigned into 1 of 8 vaccination groups (Group A, B, C, D, E, F, G or H) by chance.

Cohort 1: Approximately 450 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 one arm and placebo (an injection consisting of just salt water and no medicines in it) in the opposite arm.
  • Group B: COVID-19 vaccine, given at the same time to one arm and licensed influenza vaccine in the opposite arm.

Cohort 2: Approximately 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 one arm and placebo in the opposite arm.
  • Group D: COVID-19 vaccine, given at the same time in one arm and licenced influenza vaccine in the opposite arm.

Cohort 3: Approximately 3600 participants will be assigned by chance to one of the following:

  • Group E: Influenza and COVID-19 combination B vaccine.
  • Group F: COVID-19 vaccine.
  • Group G: Licenced influenza vaccine.
  • Group H: Investigational influenza vaccine.

All participants in cohort 1 and cohort 2 will receive 2 injections and participants in cohort 3 will receive 1 injection as per their assigned study group at Visit 1. The participants will be followed for about 6 months. During this time, researchers will assess safety and the body's reaction to the vaccination over approximately 6 months. 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 Biological: Investigational influenza vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7134 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 : November 14, 2024
Estimated Study Completion Date : November 14, 2024

Resource links provided by the National Library of Medicine


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

Experimental: Cohort 3 Arm E:Influenza and COVID-19 Combination B
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Biological: Influenza and COVID-19 Combination B
Combined influenza and Pfizer-BioNTech COVID-19 vaccine

Active Comparator: Cohort 3 Arm F: COVID-19 vaccine
Cohort 3 Arm F: COVID-19 vaccine
Biological: COVID-19 Vaccine
Pfizer-BioNTech COVID-19 vaccine

Active Comparator: Cohort 3 Arm G: Licensed influenza vaccine
Cohort 3 Arm G: Licensed influenza vaccine
Biological: Licensed influenza vaccine
Licensed influenza vaccine

Active Comparator: Cohort 3 Arm H: Investigational influenza vaccine
Cohort 3 Arm H: Investigational influenza vaccine
Biological: Investigational influenza vaccine
Investigational influenza vaccine




Primary Outcome Measures :
  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

  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]

Secondary Outcome Measures :
  1. GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine alone [ Time Frame: 4 weeks after vaccination ]
  2. GMR of SARS-CoV-2-neutralizing titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received COVID-19 vaccine alone [ Time Frame: 4 weeks after vaccination ]
  3. GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B vaccine to those who received investigational influenza vaccine alone [ Time Frame: 4 weeks after vaccination ]
  4. GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine concomitantly with COVID-19 vaccine [ Time Frame: 4 weeks after vaccination ]
  5. Difference in percentage of participants with seroconversion at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to licensed influenza vaccine administered concomitantly with COVID-19 vaccine recipients [ Time Frame: 4 weeks after vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


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


Locations
Show Show 159 study locations
Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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: June 6, 2024
Last Verified: June 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