CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 368 enrolled
Drug / intervention
Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation +1 morebiological
Likely dose
0.65 mL subcutaneous injection of zoster vaccine live (Oka/Merck)AI-extracted
Key inclusion· 2
  • ✓Age ≥50 years
  • ✓History of varicella (chickenpox)
Key exclusion· 3
  • ✕Prior herpes zoster (shingles) diagnosis
  • ✕Prior receipt of varicella or zoster vaccine
  • ✕Immunosuppressed status

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

Search/NCT00130793
NCT00130793Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)

Merck Sharp & Dohme LLC·interventional·Posted Aug 16, 2005·Updated Jan 26, 2015

In Brief

A Phase 3 clinical trial evaluating Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation and Comparator: zoster vaccine live (Oka/Merck) frozen formulation for Herpes Zoster. Completed, enrolled 368 participants.

Detailed Summary

The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2005
Enrollment StartAug 1, 2005
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 20.9 years ago

Interventions

Comparator: zoster vaccine live (Oka/Merck) refrigerated formulationbiological

1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1

Comparator: zoster vaccine live (Oka/Merck) frozen formulationbiological

1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1