CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 763 enrolled
Drug / intervention
ZOSTAVAX™ (concomitant) +2 morebiological
Likely dose
ZOSTAVAX 0.65 mL subcutaneous injection (single dose)AI-extracted
Key inclusion· 1
  • Age 50 years or older
Key exclusion· 3
  • Prior history of herpes zoster (shingles)
  • Prior receipt of varicella or zoster vaccine
  • Immunosuppressed status

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

Search/NCT00231816
NCT00231816Phase 3Completed

A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)

Merck Sharp & Dohme LLC·interventional·Posted Oct 4, 2005·Updated Sep 21, 2015

In Brief

A Phase 3 clinical trial evaluating ZOSTAVAX™ (concomitant), Comparator: Influenza Vaccine, and 1 other intervention for Herpes Zoster. Completed, enrolled 763 participants.

Detailed Summary

The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.7 years ago

Interventions

ZOSTAVAX™ (concomitant)biological

a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4

Comparator: Influenza Vaccinebiological

a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1

ZOSTAVAX™ (Nonconcomitant)biological

Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4