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NCT05901636 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults
A Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 170
- Enrollment target
NCT05901636: Completed Phase 1 study, sponsored by Janssen Vaccines & Prevention B.V..
NCT05901636 is a Phase 1 study that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 170 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (183% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05901636, a Phase 1 study, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 170 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccinatio
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL INFLUENZA G1 mHA
- BIOLOGICAL Al(OH)3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2024-08-19 |
| Phase | Phase 1 |
What the finished NCT05901636 record still lists
NCT05901636 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (183% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05901636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05901636 about?
NCT05901636 is a clinical study titled "A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults". The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (\>=) 18 to less than or equal to (\<=) 45 years of age.
What is the current status of trial NCT05901636?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2023-05-17. Estimated completion is 2024-08-19.
What interventions are being tested in trial NCT05901636?
The interventions under investigation include: Placebo (BIOLOGICAL), INFLUENZA G1 mHA (BIOLOGICAL), Al(OH)3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05901636?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05901636's enrollment target sits among peer trials
170 325th of 2000 higher than 1,675 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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