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NCT02839330 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
A Phase 3 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,196
- Enrollment target
NCT02839330: Completed Phase 3 study, sponsored by Seqirus.
NCT02839330 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 3,196 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (314% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02839330, a Phase 3 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,196 participants
- Enrollment target
Study Summary
This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to \<65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.
Primary Outcome
Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL aH5N1c
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,196 participants |
| Start Date | 2016-07-11 |
| Est. Completion | 2017-10-04 |
| Phase | Phase 3 |
What the finished NCT02839330 record still lists
NCT02839330 is an interventional study that assigns participants to a tested intervention. Its 3,196 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (314% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02839330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02839330 about?
NCT02839330 is a clinical study titled "A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age". This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio t...
What is the current status of trial NCT02839330?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,196 participants. The study started on 2016-07-11. Estimated completion is 2017-10-04.
What interventions are being tested in trial NCT02839330?
The interventions under investigation include: Placebo (BIOLOGICAL), aH5N1c (BIOLOGICAL).
Who is sponsoring clinical trial NCT02839330?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02839330's enrollment target sits among peer trials
3,196 74th of 2000 higher than 1,927 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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