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Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
NCT00539864 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.
Conditions Studied
Interventions
- BIOLOGICAL FluBlok Influenza Vaccination
- BIOLOGICAL TIV (Fluzone) Influenza Vaccination
Study Locations (5)
California
- Kaiser Permanente Pediatric Clinic - Fresno — Fresno
- Kaiser Permanente Pediatric Clinic - Hayward — Hayward
- Kaiser Permanente Pediatric Clinic - Roseville — Roseville
- Kaiser Permanente Pediatric Clinic - Sacramento — Sacramento
Hawaii
- Kaiser Permanente — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00539864
The ClinicalTrials.gov registry entry for NCT00539864 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protein Sciences Corporation, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions — of which FluBlok Influenza Vaccination is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00539864 reports 5 study locations spanning 2 distinct geographic areas — top geographies include California, Hawaii. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00539864 about?
NCT00539864 is a clinical study titled "Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV". The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.
What is the current status of trial NCT00539864?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 602 participants. The study started on 2007-09. Estimated completion is 2008-04.
What conditions does trial NCT00539864 study?
This clinical trial studies the following conditions: Influenza. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00539864?
The interventions under investigation include: FluBlok Influenza Vaccination (BIOLOGICAL), TIV (Fluzone) Influenza Vaccination (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00539864?
This trial is sponsored by Protein Sciences Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00539864 being conducted?
This trial has 5 study locations across California, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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