Trials / Completed
CompletedNCT00231816
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 763 (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 investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ZOSTAVAX™ (concomitant) | a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4 |
| BIOLOGICAL | Comparator: Influenza Vaccine | a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1 |
| BIOLOGICAL | ZOSTAVAX™ (Nonconcomitant) | Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4 |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2006-03-01
- Completion
- 2006-03-01
- First posted
- 2005-10-04
- Last updated
- 2015-09-21
- Results posted
- 2010-12-15
Source: ClinicalTrials.gov record NCT00231816. Inclusion in this directory is not an endorsement.