CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 498 enrolled
Drug / intervention
Zoster Vaccine, Live (AMP) +1 morebiological
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/NCT01505647
NCT01505647Phase 3Completed
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Jan 6, 2012·Updated Apr 12, 2017

In Brief

A Phase 3 clinical trial evaluating Zoster Vaccine, Live (AMP) and Zoster Vaccine, Live for Herpes Zoster and Shingles. Completed, enrolled 498 participants.

Detailed 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™.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.5 years ago

Interventions

Zoster Vaccine, Live (AMP)biological

One approximately 0.65-mL injection subcutaneously on Day 1

Zoster Vaccine, Livebiological

One approximately 0.65-mL injection subcutaneously on Day 1