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NCT01776541 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
A Phase 2 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 979
- Enrollment target
NCT01776541: Completed Phase 2 study, sponsored by Novartis Vaccines.
NCT01776541 is a Phase 2 study that has completed, run by Novartis Vaccines. The registered enrollment target is 979 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (636% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01776541, a Phase 2 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 979 participants
- Enrollment target
Study Summary
Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.
Primary Outcome
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceed
Interventions
- BIOLOGICAL Adjuvanted H5N1 pandemic influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 979 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01776541 record still lists
NCT01776541 is an interventional study that assigns participants to a tested intervention. The registered 979 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (636% higher).
The record links to 0 conditions, and to 1 intervention - of which Adjuvanted H5N1 pandemic influenza vaccine is the first listed.
NCT01776541 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01776541 about?
NCT01776541 is a clinical study titled "Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults". Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.
What is the current status of trial NCT01776541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 979 participants. The study started on 2013-01. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01776541?
The interventions under investigation include: Adjuvanted H5N1 pandemic influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01776541?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01776541's enrollment target sits among peer trials
979 28th of 2000 higher than 1,973 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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