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
Public ClinicalTrials.gov record NCT02839330. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Observer-Blind, Multi-center, Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02839330
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,196 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 11, 2016 (Actual)
- Primary completion
- Oct 4, 2017 (Actual)
- Completion
- Oct 4, 2017 (Actual)
- Last update posted
- Dec 6, 2024
2016 – 2017
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Optimal Research, LLC | Huntsville | Alabama | 35802 | — |
| Radiant Research | Chandler | Arizona | 85224 | — |
| Clinical Research Consortium Arizona | Tempe | Arizona | 85283 | — |
| Optimal Research Site | San Diego | California | 92108 | — |
| California Research Foundation | San Diego | California | 92123 | — |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | — |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | — |
| Optimal Research, LLC | Melbourne | Florida | 32934 | — |
| Great Lakes Clinical Trials LLC | Chicago | Illinois | 60640 | — |
| Optimal Research | Peoria | Illinois | 61614 | — |
| Heartland Research Associates | Wichita | Kansas | 67207 | — |
| Optimal Research, LLC | Rockville | Maryland | 20850 | — |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| RCR/United Medical Associates, PC | Binghamton | New York | 13901 | — |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | — |
| PMG Research of Raleigh | Raleigh | North Carolina | 60640 | — |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27609 | — |
| Aventiv Research | Columbus | Ohio | 43213 | — |
| Medical Research South | Charleston | South Carolina | 29407 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| Biogenics Research Institute | San Antonio | Texas | 78229 | — |
| J. Lewis Research Inc.-Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc. / FirstMed East | Salt Lake City | Utah | 84121 | — |
| J. Lewis Research, Inc/Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| J. Lewis Research, Inc/Jordan River Family Medicine | South Jordan | Utah | 84095 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02839330, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 6, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02839330 live on ClinicalTrials.gov.