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

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

Official Title
-----------------
A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age

Conditions
-----------------
Shingles

Intervention / Treatment
-----------------
* Biological: Zoster Vaccine, Live (Zostavax™)
* Biological: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zostavax™<br>Participants randomized to receive Zoster Vaccine, Live (Zostavax™). | Biological: Zoster Vaccine, Live (Zostavax™)<br>* A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.<br>* Other names: Zostavax™;|
| Placebo Comparator: Placebo<br>Participants randomized to receive Placebo. | Biological: Comparator: Placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Through 42 days post-vaccination |