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NCT06683352 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
A Phase 1 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,353
- Enrollment target
NCT06683352: Completed Phase 1 study, sponsored by BioNTech SE.
NCT06683352 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 1,353 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06683352, a Phase 1 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,353 participants
- Enrollment target
Study Summary
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.
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 COVID-19 Vaccine
- BIOLOGICAL Investigational Influenza Vaccine
- BIOLOGICAL Licensed Influenza Vaccine 1
- BIOLOGICAL Licensed Influenza Vaccine 2
- COMBINATION_PRODUCT Influenza and COVID Combination Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,353 participants |
| Start Date | 2024-11-11 |
| Est. Completion | 2025-07-15 |
| Phase | Phase 1 |
What the finished NCT06683352 record still lists
NCT06683352 is an interventional study that assigns participants to a tested intervention. Its 1,353 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2155% higher).
The record links to 0 conditions, and to 5 interventions - of which COVID-19 Vaccine is the first listed.
NCT06683352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06683352 about?
NCT06683352 is a clinical study titled "A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People". This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research s...
What is the current status of trial NCT06683352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,353 participants. The study started on 2024-11-11. Estimated completion is 2025-07-15.
What interventions are being tested in trial NCT06683352?
The interventions under investigation include: COVID-19 Vaccine (BIOLOGICAL), Investigational Influenza Vaccine (BIOLOGICAL), Licensed Influenza Vaccine 1 (BIOLOGICAL), Licensed Influenza Vaccine 2 (BIOLOGICAL), Influenza and COVID Combination Vaccine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06683352?
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 NCT06683352's enrollment target sits among peer trials
1,353 4th of 2000 higher than 1,997 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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