Trials / Completed
CompletedNCT01505647
Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 498 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process \[ZOSTAVAX™ (AMP)\] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Zoster Vaccine, Live (AMP) | One approximately 0.65-mL injection subcutaneously on Day 1 |
| BIOLOGICAL | Zoster Vaccine, Live | One approximately 0.65-mL injection subcutaneously on Day 1 |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2012-07-01
- Completion
- 2012-11-01
- First posted
- 2012-01-06
- Last updated
- 2017-04-12
- Results posted
- 2013-07-03
Source: ClinicalTrials.gov record NCT01505647. Inclusion in this directory is not an endorsement.