Trials / Completed
CompletedNCT00681031
Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
An Open-label, Single-arm, Phase IV Study Assessing the Immunogenicity and Safety of ZOSTAVAX® at Minimum Release Specification Approaching Expiry Potency in Subjects ≥50 Years Old.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
Primary objective: To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay \[gpELISA\]) from pre-vaccination to 4 weeks post-vaccination. Secondary objectives: To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ZOSTAVAX® | One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU |
Timeline
- Start date
- 2008-05-14
- Primary completion
- 2008-06-25
- Completion
- 2008-06-25
- First posted
- 2008-05-20
- Last updated
- 2021-06-29
- Results posted
- 2017-09-26
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00681031. Inclusion in this directory is not an endorsement.