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A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

NCT00130793 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2015-01-26

Study results available
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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.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

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

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

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
2005-08-31
Primary Completion
2005-11-30
Completion
2005-11-30

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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 NCT00130793 on ClinicalTrials.gov