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

• ClinicalTrials.gov Identifier: NCT06178991
• Recruitment Status: Recruiting
• First Posted: December 21, 2023
• Last Update Posted: April 18, 2024
• Sponsor: BioNTech SE
• Collaborator: Pfizer
• Information provided by (Responsible Party): BioNTech SE

Tracking Information

• First Submitted Date: December 20, 2023
• First Posted Date: December 21, 2023
• Last Update Posted Date: April 18, 2024
• Actual Study Start Date: December 20, 2023
• Estimated Primary Completion Date: December 5, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2024)

• 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
• 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
• 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
• 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
• 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
• 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.
• 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
• 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
• 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
• 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
• 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
• 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

Original Primary Outcome Measures (submitted: December 20, 2023)

• 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
• 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
• 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
• Percentage of participants reporting serious adverse events (SAEs) through 6 months following investigational product administration [ Time Frame: 6 months after vaccination ]
  Describe SAEs through 1 month following administration of investigational product
• 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
• 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.
• 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
• 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
• 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
• 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
• 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
• 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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

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

Condition

• Influenza
• COVID-19

Intervention

• Biological: Influenza and COVID-19 Combination A
  Combined influenza and Pfizer-BioNTech COVID-19 Vaccine
• Biological: Licensed influenza vaccine
  Licensed influenza vaccine
• Biological: COVID-19 Vaccine
  Pfizer-BioNTech COVID-19 vaccine
• Biological: Influenza and COVID-19 Combination B
  Combined influenza and Pfizer-BioNTech COVID-19 vaccine
• Biological: Placebo
  Saline Solution

Study Arms

• 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
  Interventions:

  • Biological: Influenza and COVID-19 Combination A
  • Biological: Placebo
• 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
  Interventions:

  • Biological: Licensed influenza vaccine
  • Biological: 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
  Interventions:

  • Biological: Influenza and COVID-19 Combination B
  • Biological: Placebo
• 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
  Interventions:

  • Biological: Licensed influenza vaccine
  • Biological: COVID-19 Vaccine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 20, 2023): 7500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 5, 2024
• Estimated Primary Completion Date: December 5, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06178991
• Other Study ID Numbers: C5261002
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: BioNTech SE
• Original Responsible Party: Same as current
• Current Study Sponsor: BioNTech SE
• Original Study Sponsor: Same as current
• Collaborators: Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: BioNTech SE
• Verification Date: April 2024