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NCT02045836 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
A Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 865
- Enrollment target
- 9
- Study locations
NCT02045836: Completed Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine, sponsored by GlaxoSmithKline.
NCT02045836 is a Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine that has completed, run by GlaxoSmithKline. The registered enrollment target is 865 participants, below the 2,119-participant average among 16 other Herpes Zoster trials with a reported enrollment target (59% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02045836, a Phase 3 study of Herpes Zoster and Herpes Zoster Vaccine, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 865 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response will also be evaluated.
Primary Outcome
Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad 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
Conditions Studied
Interventions
- BIOLOGICAL Herpes Zoster vaccine GSK 1437173A
- BIOLOGICAL Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
Study Locations (9)
Other
- GSK Investigational Site - Tallinn
- GSK Investigational Site - Tallinn
- GSK Investigational Site - Tartu
Colorado
- GSK Investigational Site - Golden
Kansas
- GSK Investigational Site - Wichita
Maryland
- GSK Investigational Site - Columbia
British Columbia
- GSK Investigational Site - Coquitlam
Nova Scotia
- GSK Investigational Site - Truro
Ontario
- GSK Investigational Site - Greater Sudbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 865 participants |
| Start Date | 2014-03-05 |
| Est. Completion | 2016-06-17 |
| Phase | Phase 3 |
What the finished NCT02045836 record still lists
NCT02045836 is an interventional study that assigns participants to a tested intervention. The registered 865 participants enrollment target is mid-sized for trials with a published cap, below the 2,119-participant average among 16 other Herpes Zoster trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Herpes Zoster appearing as the primary indexed condition, and to 2 interventions - of which Herpes Zoster vaccine GSK 1437173A is the first listed.
NCT02045836 lists 9 locations in 7 states (Other, Colorado, Kansas).
Frequently Asked Questions
What is clinical trial NCT02045836 about?
NCT02045836 is a clinical study titled "Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older". The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or older.The impact of HZ/su vaccine on Pneumovax 23™ vaccine immune response ...
What is the current status of trial NCT02045836?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 865 participants. The study started on 2014-03-05. Estimated completion is 2016-06-17.
What conditions does trial NCT02045836 study?
This clinical trial studies the following conditions: Herpes Zoster, Herpes Zoster Vaccine.
What interventions are being tested in trial NCT02045836?
The interventions under investigation include: Herpes Zoster vaccine GSK 1437173A (BIOLOGICAL), Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT02045836?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02045836 being conducted?
This trial has 9 study locations across Colorado, Kansas, Maryland, British Columbia, Nova Scotia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Herpes Zoster
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02045836's enrollment target sits among peer trials
865 7th of 16 higher than 10 of 16 other Herpes Zoster trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Herpes Zoster 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
-
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
ACTIVE NOT RECRUITING · Phase 3
-
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
COMPLETED · Phase 3
-
Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.
COMPLETED · Phase 3
-
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
COMPLETED · Phase 3
-
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
RECRUITING · Phase 1
-
Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
ACTIVE NOT RECRUITING
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