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NCT02290509 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
A Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,350
- Enrollment target
- 10
- Study locations
NCT02290509: Completed Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
NCT02290509 is a Phase 3 study of Influenza that has completed, run by Protein Sciences Corporation. The registered enrollment target is 1,350 participants, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02290509, a Phase 3 study of Influenza, has completed, sponsored by Protein Sciences Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,350 participants
- Enrollment target
- 10
- Study locations
Study Summary
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.
Primary Outcome
Seroconversion is defined as: Either a pre vaccination titer \< 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.
Conditions Studied
Interventions
- BIOLOGICAL Flublok Quadrivalent
- BIOLOGICAL Inactivated Influenza Vaccine (IIV4)
Study Locations (10)
Nebraska
- Meridian Research - Bellevue
- Meridian Clinical Research - Omaha
Texas
- Benchmark Reseach - Austin
- Benchmark Research - Fort Worth - Fort Worth
California
- Benchmark Research - Sacramento - Sacramento
Florida
- Clinical Research of South Florida - Coral Gables
Georgia
- Meridian Clinical Research - Savannah
Kansas
- Heartland Research Associates, LLC - Wichita
Louisiana
- Benchmark Research - Metairie
South Dakota
- Meridian Research - Dakota Dunes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,350 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT02290509 record still lists
NCT02290509 is an interventional study that assigns participants to a tested intervention. Its 1,350 participants enrollment target places it among the larger protocols in the corpus, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Flublok Quadrivalent is the first listed.
NCT02290509 lists 10 locations in 8 states (Nebraska, Texas, California).
Frequently Asked Questions
What is clinical trial NCT02290509 about?
NCT02290509 is a clinical study titled "Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age". Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subject...
What is the current status of trial NCT02290509?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,350 participants. The study started on 2014-10. Estimated completion is 2015-05.
What conditions does trial NCT02290509 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT02290509?
The interventions under investigation include: Flublok Quadrivalent (BIOLOGICAL), Inactivated Influenza Vaccine (IIV4) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02290509?
This trial is sponsored by Protein Sciences Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02290509 being conducted?
This trial has 10 study locations across California, Florida, Georgia, Kansas, Louisiana. 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 NCT02290509's enrollment target sits among peer trials
1,350 31st of 156 higher than 126 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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