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

A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)

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™.

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