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

Phase 3

Completed

• Conditions: Shingles; Herpes Zoster
• Interventions: Biological: Zoster Vaccine Live

• Registration Number: NCT01527370
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-07
• Study Start: 2012-10-31
• Primary Completion: 2013-04-09
• Study Completion: 2013-04-09
• Results First Submitted: 2013-11-11
• Results First Submitted QC: 2013-11-11
• Results First Posted: 2013-12-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-19
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoster Vaccine Live	Zoster Vaccine Live	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events	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.
The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination	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	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.