Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)

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

Time frame: 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)

Population: All randomized participants in Groups 2 and 3 who received at least 1 dose of the study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.

Blood sample taken at predose and 1 year post last vaccination to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was calculated for each arm as GMT 12-month post last dose divided by pre-vaccination GMT.

Time frame: predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)

Population: All randomized participants who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.

Blood samples were to be taken at predose and 24 months post- last vaccination in Groups 1 , 2, and 3 to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was to be calculated for each arm as GMT 24-month post last dose divided by pre-vaccination GMT.

Time frame: Predose 1 and 24 and 36 months post-last dose

Population: Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained.

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

Time frame: Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)

Population: All randomized participants in who received at least 1 dose of the study vaccine, had pre-dose 1 evaluation and had post-vaccination immunogenicity evaluation. Excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.

Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA.

Time frame: 4 weeks post-dose (Month 1)

Population: All randomized participants in Group 1 who received study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.

Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.

Time frame: 24 and 36 months post-last dose

Population: Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained.

Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.

Time frame: 1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)

Population: All randomized participants in who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis.

The number of participants who died for any reason during the study was summarized.

Time frame: up to end of study (approximately 15 months)

Population: All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.

The percentage of participants who reported an injection site reaction that was not specifically prompted by the diary card within 28 day of 1st vaccination was recorded.

Time frame: up to 28 days after 1st of study drug

Population: All randomized participants in Groups 1, 2, and 3 who received at least 1 dose of study drug and had follow-up safety data. .

The percentage of participants that reported an injection site reaction that was not specifically prompted by the diary card within 28 days post-dose 2 was recorded.

Time frame: up to 28 days post-dose 2

Population: All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and 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 28 days of 1st dose of vaccine were recorded.

Time frame: up to 28 days after 1st vaccination

Population: All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and 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 28 days of 1st dose of vaccine were recorded.

Time frame: up to 28 days after 2nd vaccination

Population: All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.

Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain

Time frame: up to 4 days after 1st vaccination

Population: All randomized participants in Groups 1, 2 and 3 who received the 1st dose of study drug and had follow-up safety data. .

Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain

Time frame: up to 4 days after 2nd vaccination

Population: All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.

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

Time frame: up to 28 days after 1st vaccination

Population: All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .

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,

Time frame: up to 28 days after 2nd vaccination

Population: All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and 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 during the entire study period that was considered at least possibly -related to the vaccine were recorded.

Time frame: up to end of study (approximately 15 months)

Population: All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.

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) and were reported as at least possibly related to the vaccine were summarized

Time frame: up to 28 days after 1st vaccination

Population: All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .

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) and were reported as at least possibly related to the vaccine were summarized,

Time frame: up to 28 days after 2nd vaccination

Population: All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.

Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded.

Time frame: up to 28 days post-dose 1

Population: All randomized participants in Groups 1, 2, and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1.

Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded.

Time frame: up to 28 days post-dose 2

Population: All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2.

Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded.

Time frame: up to 28 days post-dose 1

Population: All randomized participants in Groups 1, 2 and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1.

Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded.

Time frame: up to 28 days post-dose 2

Population: All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2.