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NCT00539864 · ClinicalTrials.gov registry record · Phase 3
Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
A Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 602
- Enrollment target
- 5
- Study locations
NCT00539864: Completed Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
NCT00539864 is a Phase 3 study of Influenza that has completed, run by Protein Sciences Corporation. The registered enrollment target is 602 participants, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00539864, a Phase 3 study of Influenza, has completed, sponsored by Protein Sciences Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 602 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Solicited reactogenicity events included injection site pain, bruising, erythema and swelling. Solicited systemic AEs included fatigue, chills, arthralgias, myalgias, headache and nausea.
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 |
What the finished NCT00539864 record still lists
NCT00539864 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower).
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.
NCT00539864 lists 5 locations in 2 states (California, Hawaii).
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.
What interventions are being tested in trial NCT00539864?
The interventions under investigation include: FluBlok Influenza Vaccination (BIOLOGICAL), TIV (Fluzone) Influenza Vaccination (BIOLOGICAL).
Who is sponsoring clinical trial NCT00539864?
This trial is sponsored by Protein Sciences Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00539864's enrollment target sits among peer trials
602 43rd of 156 higher than 114 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
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