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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Shingles

Treatments: Biological: Comparator: Placebo; Biological: Zoster Vaccine, Live (Zostavax™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534248

V211-022

2007_551

Details and patient eligibility

About

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

Enrollment: 22,439 patients

Sex: All

Ages: 50 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22,439 participants in 2 patient groups, including a placebo group

Zostavax™

Experimental group

Description:

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

Treatment:

Biological: Zoster Vaccine, Live (Zostavax™)

Placebo

Placebo Comparator group

Description:

Participants randomized to receive Placebo.

Treatment:

Biological: Comparator: Placebo