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NCT01959945 · ClinicalTrials.gov registry record · Phase 3
Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)
A Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
- 1
- Study location
NCT01959945: Completed Phase 3 study of Influenza, sponsored by Protein Sciences Corporation.
NCT01959945 is a Phase 3 study of Influenza that has completed, run by Protein Sciences Corporation. The registered enrollment target is 219 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01959945, a Phase 3 study of Influenza, has completed, sponsored by Protein Sciences Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
- 1
- Study location
Study Summary
Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study may support further studies in younger children.
Primary Outcome
Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.
Conditions Studied
Interventions
- BIOLOGICAL Flublok® Quadrivalent Influenza Virus Vaccine
- BIOLOGICAL Fluarix Quadrivalent® Influenza Virus Vaccine
Study Locations (1)
Maine
- Maine Research Associates, LLC - Auburn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01959945 record still lists
NCT01959945 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Flublok® Quadrivalent Influenza Virus Vaccine is the first listed.
NCT01959945 reports a single indexed study location in Maine.
Frequently Asked Questions
What is clinical trial NCT01959945 about?
NCT01959945 is a clinical study titled "Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)". Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity ...
What is the current status of trial NCT01959945?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2013-11. Estimated completion is 2014-10.
What conditions does trial NCT01959945 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01959945?
The interventions under investigation include: Flublok® Quadrivalent Influenza Virus Vaccine (BIOLOGICAL), Fluarix Quadrivalent® Influenza Virus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01959945?
This trial is sponsored by Protein Sciences Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01959945 being conducted?
This trial has 1 study location across Maine. 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 NCT01959945's enrollment target sits among peer trials
219 79th of 156 higher than 78 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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Study of Quadrivalent Influenza Vaccine Among Children
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-
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
COMPLETED · Phase 3
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