Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.

Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom 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 study vaccine administration documented, who had filled in their symptom sheets.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 1.

Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 3.

Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).

The analysis was performed on the Total Vaccinated cohort which which included all subjects with at least one study vaccine administration documented and with available results at Day 7.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 30.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 31.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 33.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 37.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 60.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 180.

Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 360.

Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.

The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration 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 out-side 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.

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

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

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

Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 360, for the same parameter, e.g. ALT G0-G2.

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

Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.

Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.

Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.

IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.