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NCT01751165 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 354
- Enrollment target
NCT01751165: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01751165 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 354 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01751165, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 354 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is not known.
Primary Outcome
Vaccine response was 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. The objective required a comparison of VRR between 0,6-months and 0,12-months schedules.
Interventions
- BIOLOGICAL Herpes zoster vaccine GSK1437173A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2013-03-12 |
| Est. Completion | 2015-04-08 |
| Phase | Phase 3 |
What the finished NCT01751165 record still lists
NCT01751165 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which Herpes zoster vaccine GSK1437173A is the first listed.
NCT01751165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01751165 about?
NCT01751165 is a clinical study titled "Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older". The purpose of this study is to assess the safety and immunogenicity of the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule in adults aged 50 years or above, as the immunogenicity of the HZ vaccine administered at intervals longer than two months is no...
What is the current status of trial NCT01751165?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 354 participants. The study started on 2013-03-12. Estimated completion is 2015-04-08.
What interventions are being tested in trial NCT01751165?
The interventions under investigation include: Herpes zoster vaccine GSK1437173A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01751165?
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 NCT01751165's enrollment target sits among peer trials
354 1026th of 2000 higher than 973 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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