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™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
498
One approximately 0.65-mL injection subcutaneously on Day 1
One approximately 0.65-mL injection subcutaneously on Day 1
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time frame: 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).
Time frame: Day 1 (Baseline) to Week 6 postvaccination
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.
Time frame: 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
Time frame: 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
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Time frame: Day 1 to Day 182 postvaccination