A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation; Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00130793

V211-010

2005_035

Details and patient eligibility

About

The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

Full description

The duration of treatment is 4 weeks.

Enrollment: 368 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)

Exclusion criteria

• Prior history of herpes zoster (shingles)
• Prior receipt of varicella or zoster vaccine
• Immunosuppressed

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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368 participants in 2 patient groups

zoster vaccine live (Oka/Merck) refrigerated formulation

Experimental group

Description:

ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (\~45,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65-mL injection

Treatment:

Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation

zoster vaccine live (Oka/Merck) frozen formulation

Active Comparator group

Description:

ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (\~57,000 PFU), 1 subcutaneous 0.65-mL injection

Treatment:

Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation