Trials / Completed
CompletedNCT00130793
A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 368 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.
Detailed description
The duration of treatment is 4 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation | 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1 |
| BIOLOGICAL | Comparator: zoster vaccine live (Oka/Merck) frozen formulation | 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1 |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2005-11-01
- Completion
- 2005-11-01
- First posted
- 2005-08-16
- Last updated
- 2015-01-26
- Results posted
- 2009-07-03
Source: ClinicalTrials.gov record NCT00130793. Inclusion in this directory is not an endorsement.