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NCT02207413 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,886
- Enrollment target
NCT02207413 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,886 participants.
The verdict
NCT02207413, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,886 participants
- Enrollment target
Study Summary
The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process \[LP\]).
Interventions
- BIOLOGICAL Influsplit Tetra™ vaccine produced by investigational process (IP)
- BIOLOGICAL Influsplit Tetra™ vaccine produced by licensed process (LP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,886 participants |
| Start Date | 2014-08-18 |
| Est. Completion | 2015-04-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02207413
The ClinicalTrials.gov registry entry for NCT02207413 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,886 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Influsplit Tetra™ vaccine produced by investigational process (IP) is the first listed.
NCT02207413 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02207413 about?
NCT02207413 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children". The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU...
What is the current status of trial NCT02207413?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,886 participants. The study started on 2014-08-18. Estimated completion is 2015-04-18.
What interventions are being tested in trial NCT02207413?
The interventions under investigation include: Influsplit Tetra™ vaccine produced by investigational process (IP) (BIOLOGICAL), Influsplit Tetra™ vaccine produced by licensed process (LP) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02207413?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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