Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
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|ClinicalTrials.gov Identifier: NCT00681031|
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
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.
To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: ZOSTAVAX®||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||May 31, 2008|
|Actual Primary Completion Date :||June 30, 2008|
|Actual Study Completion Date :||October 31, 2008|
Experimental: All Enrolled
Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)
One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU
- Geometric Mean Titre (GMT) of Varicella Antibodies [ Time Frame: Predose (Day 0) and Day 28-35 Post Dose ]Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681031
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|