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A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)

NCT00231816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 763

Last updated 2015-09-21

Study results available
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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.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

ZOSTAVAX™ (concomitant)

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

BIOLOGICAL

Comparator: Influenza Vaccine

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

BIOLOGICAL

ZOSTAVAX™ (Nonconcomitant)

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-03-31
Completion
2006-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231816 on ClinicalTrials.gov