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ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

NCT00550745 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11999

Last updated 2017-04-12

Study results available
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Summary

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

Zoster Vaccine, Live

single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.

BIOLOGICAL

Comparator: placebo

single 0.65 mL Placebo injection. 6 month treatment period.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-01-31
Completion
2009-01-31

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Entities

Companies

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 NCT00550745 on ClinicalTrials.gov