Phase 3
N=8,795
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
Influenza · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT06178991 ↗Enrolled (actual)
8,795
Serious AEs
1.0%
Results posted
Dec 2025
Primary outcome: Primary: Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity — 74.7; 59.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioNTech SE
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity |
74.7; 59.1 | — |
| PRIMARY Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity |
73.4; 63.5 | — |
| PRIMARY Cohort 3: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine Extremity |
73.4; 62.5; 34.8; 66.3 | — |
| PRIMARY Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination |
71.8; 54.1 | — |
| PRIMARY Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination |
70.8; 59.9 | — |
| PRIMARY Cohort 3: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination |
66.7; 52.1; 43.9; 61.1 | — |
| PRIMARY Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination |
5.8; 10.1 | — |
| PRIMARY Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination |
6.4; 6.1 | — |
| PRIMARY Cohort 3: Percentage of Participants Reporting AEs From Vaccination Through 4 Weeks After Vaccination |
3.8; 4.8; 4.1; 4.1 | — |
| PRIMARY Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination |
0.6; 2.5 | — |
| PRIMARY Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination |
0.7; 1.4 | — |
| PRIMARY Cohort 3: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination |
0.8; 1.3; 0.8; 1.2 | — |
| PRIMARY Cohort 2: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at 4 Weeks After Vaccination: Non-inferiority |
188.3; 136.3; 165.9; 96.9; 37.4; 56.4 | — |
| PRIMARY Cohort 2: Percentage of Participants and Difference in Percentage of Participants With Strain-Specific HAI Seroconversion at 4 Weeks After Vaccination: Non-inferiority |
72.8; 54.9; 65.7; 40.1; 31.7; 45.4 | — |
| PRIMARY Cohort 2: GMT and GMR of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority |
3535.1; 3476.6 | — |
| PRIMARY Cohort 2: Percentage of Participants and Difference in Percentage of Participants With SARS-CoV-2 Seroresponse at 4 Weeks After Vaccination: Non-inferiority |
75.5; 73.7 | — |
| SECONDARY Cohort 3: GMT and GMR of Strain-Specific HAI Titers at 4 Weeks After Vaccination: Non-inferiority |
165.6; 142.5; 170.2; 175.7; 100.1; 190.4 | — |
| SECONDARY Cohort 3: GMT and GMR of SARS-CoV-2 Neutralizing Titers at 4 Weeks After Vaccination: Non-inferiority |
3841.0; 4208.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT06178991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.