Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter [mIU/ml]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).

The analysis was performed on the According-to-Protocol (ATP) cohort for humoral immunogenicity, which included all evaluable subjects up to Month 2, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Pain when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Assessed solicited local symptoms were pain, redness and swelling.

The analysis was performed on the subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain.

The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].

The analysis was performed on the subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Renal allograft rejection was confirmed through biopsy.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented.

The analysis was performed on subjects with pre and post vaccination serum creatinine data available up to Month 2, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL.

The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.

Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by ELISA.

The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.

Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS).

The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).

Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/10 million CD4+ T-cells); For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.

The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.If a subject reported a SAE exactly 1 month post-last vaccination (Month 2), it is possible that he/she might have also been taken into consideration for the Day0 up to Month2 SAEs assessment

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Renal allograft rejection was confirmed through biopsy.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.

Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented.

The analysis was performed on subjects with pre and post vaccination serum creatinine data available from Month 2 to Month 13, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.