Trials / Completed
CompletedNCT05219253
A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India
A Phase 3, Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Immune Response and Safety of the Herpes Zoster Subunit Vaccine When Administered Intramuscularly on a 2-dose Schedule in Adults Aged 50 Years and Older in India
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HZ/su | Two doses of the HZ/su vaccine administered intramuscularly, one each at Day 1 and Month 2. |
| DRUG | Placebo | Two doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) administered intramuscularly, one each at Day 1 and Month 2. |
Timeline
- Start date
- 2022-02-02
- Primary completion
- 2022-10-11
- Completion
- 2022-12-12
- First posted
- 2022-02-02
- Last updated
- 2025-05-15
- Results posted
- 2024-04-08
Locations
9 sites across 1 country: India
Source: ClinicalTrials.gov record NCT05219253. Inclusion in this directory is not an endorsement.