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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

ClinicalTrials.gov ID: NCT00539981

Public ClinicalTrials.gov record NCT00539981. 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 Sep 1, 2026, 2:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of the Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok® Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine in Healthy Adults Aged 18 to 49 Years

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of participants.

Study identification

NCT ID
NCT00539981
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
4,648 participants

Conditions and interventions

Conditions

Interventions

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
Sep 14, 2007
Primary completion
May 27, 2008
Completion
May 27, 2008
Last update posted
Apr 5, 2022

2007 – 2008

United States locations

U.S. sites
24
U.S. states
17
U.S. cities
23
Facility City State ZIP Site status
Impact Clinical Trials Beverly Hills California 90211
Benchmark Research - Sacramento Sacramento California 95816
Benchmark Research - San Francisco San Francisco California 94102
University Clinical Research, Inc Pembroke Pines Florida 33024
Vince and Associates Overland Park Kansas 66212
Kentucky pediatric /Adult Research Bardstown Kentucky 40004
Benchmarch Research - New Orleans Metairie Louisiana 70006
University of Maryland - Baltimore Baltimore Maryland 21201
Saint Louis University St Louis Missouri 63110
Meridian Clinical Research Omaha Nebraska 68134
Regional Clinical Research, Inc. Endwell New York 13760
Rochester Medical Center Rochester New York 14642
Carolina Medical Trials Winston-Salem North Carolina 27103
Sterling Research Cincinnati Ohio 45246
Primary Physicians Research - Pediatric Alliance St. Clair Pittsburgh Pennsylvania 15241
Primary Physicians Research Pittsburgh Pennsylvania 15241
Vanderbilt University Medical Center Nashville Tennessee 37232
Benchmarch Research - Austin Austin Texas 78705
Benchmark Research - Fort Worth Fort Worth Texas 76135
Baylor College of Medicine Houston Texas 77030
Benchmark Research - San Angelo San Angelo Texas 76904
Jean Brown Research Salt Lake City Utah 84124
University of Virginia Health System Charlottesville Virginia 22908
Marshfield Clinic Marshfield Wisconsin 54449

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 NCT00539981, 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 Apr 5, 2022 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00539981 live on ClinicalTrials.gov.

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