Trials / Completed
CompletedNCT01777321
Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years
Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Versus Intramuscularly in Adults Aged 50 Years or Older
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.
Detailed description
There are 2 treatment groups in this study based upon the mode of vaccine administration. The humoral immunogenicity (HI) will be measured in all subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Herpes zoster vaccine GSK1437173A | HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule. |
Timeline
- Start date
- 2013-06-17
- Primary completion
- 2013-10-10
- Completion
- 2014-11-11
- First posted
- 2013-01-28
- Last updated
- 2018-10-25
- Results posted
- 2017-01-06
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01777321. Inclusion in this directory is not an endorsement.