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NCT06178991 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
A Phase 3 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 3
- Development phase
- 8,795
- Enrollment target
NCT06178991: Completed Phase 3 study, sponsored by BioNTech SE.
NCT06178991 is a Phase 3 study that has completed, run by BioNTech SE. The registered enrollment target is 8,795 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1041% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06178991, a Phase 3 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8,795 participants
- Enrollment target
Study 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 m
Primary Outcome
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL COVID-19 Vaccine
- BIOLOGICAL Licensed influenza vaccine
- BIOLOGICAL Influenza and COVID-19 Combination A
- BIOLOGICAL Influenza and COVID-19 Combination B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,795 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2024-11-26 |
| Phase | Phase 3 |
What the finished NCT06178991 record still lists
NCT06178991 is an interventional study that assigns participants to a tested intervention. Its 8,795 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1041% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT06178991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06178991 about?
NCT06178991 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.". 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 an...
What is the current status of trial NCT06178991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,795 participants. The study started on 2023-12-20. Estimated completion is 2024-11-26.
What interventions are being tested in trial NCT06178991?
The interventions under investigation include: Placebo (BIOLOGICAL), COVID-19 Vaccine (BIOLOGICAL), Licensed influenza vaccine (BIOLOGICAL), Influenza and COVID-19 Combination A (BIOLOGICAL), Influenza and COVID-19 Combination B (BIOLOGICAL).
Who is sponsoring clinical trial NCT06178991?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06178991's enrollment target sits among peer trials
8,795 32nd of 2000 higher than 1,969 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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