CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 600 enrolled
Drug / intervention
Zoster Vaccine, Livebiological
Likely dose
Not stated in 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/NCT01245751
NCT01245751Phase 3Completed
CompareCT.gov

Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™

Merck Sharp & Dohme LLC·interventional·Posted Nov 22, 2010·Updated Apr 12, 2017

In Brief

A Phase 3 clinical trial evaluating Zoster Vaccine, Live for Herpes Zoster and Varicella-zoster Vaccine. Completed, enrolled 600 participants.

Detailed Summary

This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster, Varicella-zoster Vaccine
Countries--
CollaboratorsUniversity of Colorado, Denver, Duke University

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 22, 2010
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2012
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.6 years ago

Interventions

Zoster Vaccine, Livebiological

Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study