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NCT02052596 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 935
- Enrollment target
NCT02052596: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02052596 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 935 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02052596, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 935 participants
- Enrollment target
Study Summary
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Primary Outcome
This outcome was required only for the GSK1437173A Group. Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Interventions
- BIOLOGICAL Herpes Zoster vaccine GSK 1437173A
- BIOLOGICAL Boostrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 935 participants |
| Start Date | 2014-02-07 |
| Est. Completion | 2016-04-21 |
| Phase | Phase 3 |
What the finished NCT02052596 record still lists
NCT02052596 is an interventional study that assigns participants to a tested intervention. The registered 935 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 2 interventions - of which Herpes Zoster vaccine GSK 1437173A is the first listed.
NCT02052596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02052596 about?
NCT02052596 is a clinical study titled "Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older". The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
What is the current status of trial NCT02052596?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 935 participants. The study started on 2014-02-07. Estimated completion is 2016-04-21.
What interventions are being tested in trial NCT02052596?
The interventions under investigation include: Herpes Zoster vaccine GSK 1437173A (BIOLOGICAL), Boostrix (BIOLOGICAL).
Who is sponsoring clinical trial NCT02052596?
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 NCT02052596's enrollment target sits among peer trials
935 338th of 2000 higher than 1,663 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
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