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

Study Overview
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Brief Summary
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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™.

Official Title
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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)

Conditions
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Shingles, Herpes Zoster

Intervention / Treatment
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* Biological: Zoster Vaccine, Live (AMP)
* Biological: Zoster Vaccine, Live


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOSTAVAX™ (AMP)<br>ZOSTAVAX™ manufactured with an alternative process | Biological: Zoster Vaccine, Live (AMP)<br>* One approximately 0.65-mL injection subcutaneously on Day 1<br>|
| Active Comparator: ZOSTAVAX™<br>ZOSTAVAX™ manufactured with the current process | Biological: Zoster Vaccine, Live<br>* One approximately 0.65-mL injection subcutaneously on Day 1<br>* Other names: V211;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody | VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA) | Day 1 and Week 6 postvaccination | 
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers | VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline). | Day 1 (Baseline) to Week 6 postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Adverse Experiences (AEs) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. | Day 1 to Day 42 postvaccination | 
| Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination | An SAE is defined as 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 | Day 1 to Day 42 postvaccination | 
| Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination | An SAE is defined as 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 | Day 1 to Day 182 postvaccination |