Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-09

Brief Summary

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This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.

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Detailed Description

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Conditions

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Herpes Zoster Shingles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Zoster Vaccine Live

Group Type EXPERIMENTAL

Zoster Vaccine Live

Intervention Type BIOLOGICAL

One approximately 0.65 mL injection subcutaneously on Day 1

Interventions

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Zoster Vaccine Live

One approximately 0.65 mL injection subcutaneously on Day 1

Intervention Type BIOLOGICAL

Other Intervention Names

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ZOSTAVAX™ V211

Eligibility Criteria

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Inclusion Criteria

* No fever on day of vaccination
* Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
* Underlying chronic illnesses must be stable

Exclusion Criteria

* History of hypersensitivity reaction to any vaccine component
* Prior receipt of a varicella or zoster vaccine
* Prior history of herpes zoster
* Have recently had another vaccination
* Have recently received blood products other than autologous blood transfusion
* Pregnant or breast feeding
* Use of immunosuppressive therapy
* Known or suspected immune dysfunction
* Use of nontopical antiviral therapy with activity against herpesvirus

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes