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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Shingles; Herpes Zoster

Treatments: Biological: Zoster Vaccine Live

Study type: Interventional

Funder types: Industry

Identifiers

NCT01527370

V211-025

CTRI/2012/08/002922 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

250 participants in 1 patient group

Zoster Vaccine Live

Experimental group

Treatment:

Biological: Zoster Vaccine Live