Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Shingles; Herpes Zoster

Treatments: Biological: Zoster Vaccine, Live; Biological: Zoster Vaccine, Live (AMP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505647

V211-042

Details and patient eligibility

About

This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.

Enrollment: 498 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No fever on day of vaccination
• History of varicella or residence in a VZV-endemic area for ≥30 years
• Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion criteria

• History of hypersensitivity reaction to any vaccine component
• Prior receipt of any varicella or zoster vaccine
• Prior history of herpes zoster
• Have recently had another vaccination
• Pregnant or breastfeeding
• Use of immunosuppressive therapy
• Known or suspected immune dysfunction
• Concomitant antiviral therapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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498 participants in 2 patient groups

ZOSTAVAX™ (AMP)

Experimental group

Description:

ZOSTAVAX™ manufactured with an alternative process

Treatment:

Biological: Zoster Vaccine, Live (AMP)

ZOSTAVAX™

Active Comparator group

Description:

ZOSTAVAX™ manufactured with the current process

Treatment:

Biological: Zoster Vaccine, Live