ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

Official Title
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A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: Zoster Vaccine, Live
* Biological: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60+ years of Age Signed an informed consent prior to the start of study Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination Females must be postmenopausal or have a negative pregnancy test Exclusion Criteria: A history of allergic reaction to any vaccine component (including gelatin or neomycin) Prior receipt of any varicella or zoster vaccine Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination Subject is pregnant or breastfeeding Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir

Ages Eligible for Study
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Minimum Age: 60 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: vaccine | Biological: Zoster Vaccine, Live<br>* single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.<br>|
| Placebo Comparator: 2<br>Arm 2: Placebo Comparator | Biological: Comparator: placebo<br>* single 0.65 mL Placebo injection. 6 month treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events Reported Within 42 Days Postvaccination | Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. | 42 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. | 6 months |