Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

Time frame: Pre-vaccination (Day 0) and 4 week post-vaccination

Population: All randomised participants who had received the study vaccine via IM route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.

Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).

Time frame: 4 week post-vaccination

Population: All randomised participants who had received the study vaccine, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.

Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10\^6 Peripheral Blood Mononuclear Cells (PBMC)

Time frame: 4 week post-vaccination

Population: All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid post-vaccination data for endpoint.

Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination

Time frame: Pre-vaccination (Day 0) and 4 week post-vaccination

Population: All randomised participants who had received the study vaccine via SC route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.

Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.

Time frame: Pre-vaccination (Day 0) and 4 week post-vaccination

Population: All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid pre- and post-vaccination data for endpoint.

Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.

Time frame: up to 28 days after vaccination

Population: All vaccinated participants who had follow-up safety data.

A serious adverse event (SAE) 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. The percentage of participants who reported an SAE within 35 days of vaccination were recorded.

Time frame: up to 35 days after vaccination

An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.

Time frame: up to Day 28 after vaccination

Population: All vaccinated participants who had follow-up safety data.