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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: ZOSTAVAX®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Enrolled<br>Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0) | Biological: ZOSTAVAX®<br>* One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titre (GMT) of Varicella Antibodies | Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA). | Predose (Day 0) and Day 28-35 Post Dose |