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

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

Completed

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Shingles Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoster Vaccine Live

Biological

One approximately 0.65 mL injection subcutaneously on Day 1

Other names: ZOSTAVAX™, V211

Primary outcomes

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

Time frame: Prevaccination up to 6 weeks postvaccination

Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination

Time frame: Prevaccination up to 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.
Number of Participants With Serious Adverse Events

Time frame: Up to 42 days postvaccination

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Feb 7, 2012
Registry last updated: Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed