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

Phase 3CompletedNCT01527370

Merck Sharp & Dohme LLC250 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

250

Conditions

Herpes Zoster Shingles

Interventions

Zoster Vaccine LiveBIOLOGICAL

One approximately 0.65 mL injection subcutaneously on Day 1

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination

Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).

Time frame: Prevaccination up to 6 weeks postvaccination

Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination

GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.

Time frame: Prevaccination up to 6 weeks postvaccination

Number of Participants With Serious Adverse Events

A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Time frame: Up to 42 days postvaccination

Data from ClinicalTrials.gov

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