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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01959945
The ClinicalTrials.gov registry entry for NCT01959945 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is Protein Sciences Corporation, which has 12 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.