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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection

ClinicalTrials.gov ID: NCT00800605

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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 2:38 AM EDT

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

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
Dec 2008 (Type not available)
Primary completion
May 2009 (Actual)
Completion
Jun 2009 (Actual)
Last update posted
Nov 24, 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 24, 2025 · 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 NCT00800605 live on ClinicalTrials.gov.

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