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Benchmark Research | Austin, TX

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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.

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BioNTech

Status and phase

Active, not recruiting
Phase 3

Conditions

COVID-19
Influenza

Treatments

Biological: COVID-19 Vaccine
Biological: Investigational influenza vaccine
Biological: Licensed influenza vaccine
Biological: Placebo
Biological: Influenza and COVID-19 Combination A
Biological: Influenza and COVID-19 Combination B

Study type

Interventional

Funder types

Industry

Identifiers

NCT06178991
C5261002

Details and patient eligibility

About

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.

Enrollment

7,134 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

7,134 participants in 8 patient groups

Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo
Experimental group
Description:
Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Treatment:
Biological: Influenza and COVID-19 Combination A
Biological: Placebo
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Active Comparator group
Description:
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Treatment:
Biological: Licensed influenza vaccine
Biological: COVID-19 Vaccine
Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo
Experimental group
Description:
Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Treatment:
Biological: Influenza and COVID-19 Combination B
Biological: Placebo
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Active Comparator group
Description:
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Treatment:
Biological: Licensed influenza vaccine
Biological: COVID-19 Vaccine
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Experimental group
Description:
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Treatment:
Biological: Influenza and COVID-19 Combination B
Cohort 3 Arm F: COVID-19 vaccine
Active Comparator group
Description:
Cohort 3 Arm F: COVID-19 vaccine
Treatment:
Biological: COVID-19 Vaccine
Cohort 3 Arm G: Licensed influenza vaccine
Active Comparator group
Description:
Cohort 3 Arm G: Licensed influenza vaccine
Treatment:
Biological: Licensed influenza vaccine
Cohort 3 Arm H: Investigational influenza vaccine
Active Comparator group
Description:
Cohort 3 Arm H: Investigational influenza vaccine
Treatment:
Biological: Investigational influenza vaccine

Trial contacts and locations

158

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Central trial contact

Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

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