Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

Phase 3

Completed

• Conditions: Shingles
• Interventions: Biological: Zoster Vaccine, Live (Zostavax™)

• Registration Number: NCT00534248
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-24
• Study Start: 2007-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-01-04
• Results First Submitted QC: 2011-03-31
• Results First Posted: 2011-05-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22439

Inclusion Criteria

• Must be between 50 - 59 years of age
• No fever on day of vaccination
• Females of reproductive potential must be willing to use acceptable form of birth control

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Exclusion Criteria

• Have received chicken pox or shingles vaccine
• Have already had shingles
• Have recently had another vaccination
• Pregnant or breast feeding. Have participated in another research study in the last 30 days
• You are taking certain antiviral drugs
• History of allergic reaction to any vaccine component, including gelatin or neomycin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zostavax™	Zoster Vaccine, Live (Zostavax™)	Participants randomized to receive Zoster Vaccine, Live (Zostavax™).

Primary Outcome Measures

Name	Time	Method
Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group	2 Years	Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.

Secondary Outcome Measures

Name	Time	Method
Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group	6 Weeks	VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.
Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period	Through 42 days post-vaccination	A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing; hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.