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

Phase 3CompletedNCT00534248

Merck Sharp & Dohme LLC22,439 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

22,439

Conditions

Shingles

Interventions

Zoster Vaccine, Live (Zostavax™)BIOLOGICAL

A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.

Comparator: PlaceboBIOLOGICAL

A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group

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.

Time frame: 2 Years

Secondary Outcomes

Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group

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.

Time frame: 6 Weeks

Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period

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.

Time frame: Through 42 days post-vaccination

Data from ClinicalTrials.gov

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