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NCT02360475 · ClinicalTrials.gov registry record · Phase 2
Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 507
- Enrollment target
NCT02360475: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02360475 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 507 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (281% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02360475, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 507 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
Primary Outcome
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
Interventions
- BIOLOGICAL Boostrix
- BIOLOGICAL RSV vaccine GSK3003895A (formulation 1)
- BIOLOGICAL RSV vaccine GSK3003898A (formulation 2)
- BIOLOGICAL RSV vaccine GSK3003899A (formulation 3)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2015-03-20 |
| Est. Completion | 2016-06-21 |
| Phase | Phase 2 |
What the finished NCT02360475 record still lists
NCT02360475 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (281% higher).
The record links to 0 conditions, and to 4 interventions - of which Boostrix is the first listed.
NCT02360475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02360475 about?
NCT02360475 is a clinical study titled "Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women". The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
What is the current status of trial NCT02360475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 507 participants. The study started on 2015-03-20. Estimated completion is 2016-06-21.
What interventions are being tested in trial NCT02360475?
The interventions under investigation include: Boostrix (BIOLOGICAL), RSV vaccine GSK3003895A (formulation 1) (BIOLOGICAL), RSV vaccine GSK3003898A (formulation 2) (BIOLOGICAL), RSV vaccine GSK3003899A (formulation 3) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02360475?
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 NCT02360475's enrollment target sits among peer trials
507 69th of 2000 higher than 1,932 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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