Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

An Open-label, Single-arm, Phase IV Study Assessing the Immunogenicity and Safety of ZOSTAVAX® at Minimum Release Specification Approaching Expiry Potency in Subjects ≥50 Years Old.

Primary objective:

To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay [gpELISA]) from pre-vaccination to 4 weeks post-vaccination.

Secondary objectives:

To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.

Inclusion Criteria:

• Participant of either gender aged ≥50 years
• Positive history of varicella or residence for >30 years in a country with endemic VZV infection
• All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination
• Participant having signed the informed consent form prior to any study procedure

Exclusion Criteria:

• Febrile within 72 hours prior to vaccination
• Prior history of Herpes Zoster clinically diagnosed by a physician
• Previously received a varicella or zoster vaccine
• Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination
• Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
• Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study
• Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study
• Taking any non topical antiviral therapy with activity against herpesviruses.
• On immunosuppressive therapy
• Known or suspected immune dysfunction caused by a medical condition, or any other cause
• History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
• Known active tuberculosis
• Significant underlying illness preventing completion of the study