CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 96 enrolled
Drug / intervention
ZOSTAVAX®biological
Likely dose
ZOSTAVAX® 0.65 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00681031
NCT00681031Phase 4Completed
CompareCT.gov

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.

Merck Sharp & Dohme LLC·interventional·Posted May 20, 2008·Updated Jun 29, 2021

In Brief

A Phase 4 clinical trial evaluating ZOSTAVAX® for Herpes Zoster. Completed, enrolled 96 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartMay 14, 2008
Primary CompletionJun 25, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 18.1 years ago

Interventions

ZOSTAVAX®biological

One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU