Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02207413 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,886 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
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 \[LP\]).
Primary Outcome
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. \>100mm.
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 |
What the finished NCT02207413 record still lists
NCT02207413 is an interventional study that assigns participants to a tested intervention. Its 1,886 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (144% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02207413's enrollment target sits among peer trials
1,886 113th of 2000 higher than 1,888 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06438640 · 1,881 participants · NA
Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)
- NCT07308717 · 1,896 participants · Phase 4
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
- NCT05675410 · 1,875 participants · Phase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
- NCT06891898 · 1,875 participants
The iLet Experience Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI