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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 is a Phase 3 study that has completed, run by Seqirus. The registered enrollment target is 3,196 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02839330
The ClinicalTrials.gov registry entry for NCT02839330 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seqirus, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02839330 reports 0 study locations.
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.
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