Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection
Public ClinicalTrials.gov record NCT00800605. 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
Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine to Prevent Culture Confirmed Influenza Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to demonstrate the efficacy of an investigational Vero cell-derived, trivalent, seasonal influenza vaccine to prevent infection with an influenza virus that is antigenically similar to one of the three strains in the vaccine. Subjects will be randomized in a double-blind fashion to receive a single intramuscular injection of either the investigational vaccine or placebo. Blood will be drawn from all subjects for a determination of hemagglutination inhibition antibody titers on Days 0 and 21, body temperature and injection site reactions will be monitored daily for 7 days. In addition, subjects must return to the clinic promptly to have swab samples of their nose and throat taken whenever they feel flu symptoms and all subjects will be monitored for adverse events until Day 180.
Study identification
- NCT ID
- NCT00800605
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 7,250 participants
Conditions and interventions
Conditions
Interventions
- Vero cell-derived, trivalent, seasonal influenza vaccine Biological
- Placebo: Phosphate-buffered saline Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- 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
- Nov 30, 2008
- Primary completion
- Apr 30, 2009
- Completion
- May 31, 2009
- Last update posted
- Nov 23, 2025
2008 – 2009
United States locations
- U.S. sites
- 36
- U.S. states
- 21
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Quality of Life Medical & Research Center, LLC | Tucson | Arizona | 85712 | — |
| Benchmark Research | Sacramento | California | 95816 | — |
| California Research Foundation | San Diego | California | 92103 | — |
| Benchmark Research San Francisco | San Francisco | California | 94102 | — |
| Radiant Research, Inc | Denver | Colorado | 80239 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Pharmax Research Clinic | Miami | Florida | 33126 | — |
| University Clinical Research, Inc | Pembroke Pines | Florida | 33024 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| Radiant Research, Inc - Chicago | Chicago | Illinois | 60654 | — |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | — |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | — |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | — |
| Benchmark Research | Metairie | Louisiana | 70006 | — |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Radiant Research, Inc. | St Louis | Missouri | 63141 | — |
| Sundance Clinical Research | St Louis | Missouri | 63141 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Regional Clinical Research, Inc. | Endwell | New York | 13760 | — |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | — |
| Triangle Medical Research Associates | Raleigh | North Carolina | 27609 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | — |
| Radiant Research - Cincinnati | Cincinnati | Ohio | 45249 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Clinical Research Associates, Inc. - Nashville | Nashville | Tennessee | 37203 | — |
| Benchmark Research Austin | Austin | Texas | 78705 | — |
| Benchmark Research Ft. Worth | Fort Worth | Texas | 76135 | — |
| Benchmark Research San Angeolo | San Angelo | Texas | 76904 | — |
| Jean Brown Research / Westside Medical | Salt Lake City | Utah | 84124 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| PI-COOR Clinical Research | Burke | Virginia | 22015 | — |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | — |
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 NCT00800605, 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 Nov 23, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00800605 live on ClinicalTrials.gov.