CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 223 enrolled
Drug / intervention
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous +5 morebiological
Likely dose
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous 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/NCT01385566
NCT01385566Phase 1Completed

A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)

Merck Sharp & Dohme LLC·interventional·Posted Jun 30, 2011·Updated Jun 23, 2016

In Brief

A Phase 1 clinical trial evaluating ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous, ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous, and 4 other interventions for Herpes Zoster. Completed, enrolled 223 participants.

Detailed Summary

This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2011
Enrollment StartSep 1, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.0 years ago

Interventions

ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneousbiological

One 0.65 mL injection subcutaneously on Day 1

ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneousbiological

One approximately 0.22 mL injection subcutaneously on Day 1

ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermalbiological

Two intradermal injections of approximately 0.15 mL each on Day 1

ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermalbiological

One intradermal injection of approximately 0.1 mL on Day 1

Full Dose Intradermal Placebobiological

Two intradermal placebo injections of approximately 0.15 mL each on Day 1

Intradermal Placebobiological

One intradermal placebo injection of approximately 0.1 mL on Day 1