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NCT01954251 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 829
- Enrollment target
NCT01954251: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01954251 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 829 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954251, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 829 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 FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Primary Outcome
The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase
Interventions
- BIOLOGICAL Herpes Zoster vaccine GSK 1437173A
- BIOLOGICAL GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 829 participants |
| Start Date | 2013-10-03 |
| Est. Completion | 2015-03-20 |
| Phase | Phase 3 |
What the finished NCT01954251 record still lists
NCT01954251 is an interventional study that assigns participants to a tested intervention. The registered 829 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Herpes Zoster vaccine GSK 1437173A is the first listed.
NCT01954251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01954251 about?
NCT01954251 is a clinical study titled "Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A 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 FLU-D-QIV vaccine in adults aged 50 years or older compared to administration of vaccines separately.
What is the current status of trial NCT01954251?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 829 participants. The study started on 2013-10-03. Estimated completion is 2015-03-20.
What interventions are being tested in trial NCT01954251?
The interventions under investigation include: Herpes Zoster vaccine GSK 1437173A (BIOLOGICAL), GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01954251?
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 NCT01954251's enrollment target sits among peer trials
829 400th of 2000 higher than 1,601 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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