This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.
All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
600
Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Time frame: Day 1 (Baseline) and Week 6 postvaccination
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
Time frame: Day 1 (Baseline) and Week 6 postvaccination
Number of Participants Reporting One or More Adverse Experiences
An adverse experience (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. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.
Time frame: Up to 42 days postvaccination
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