Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm). Solicited local symptoms, for this endpoint, were assessed in all subjects, in both groups.

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

Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm), for children between 1-5 years old; > 50 mm for children between 6-12 years old and >100 mm for children between 13-17 years old.

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

Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in all subjects, in both groups.

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

Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. Symptoms with no values were not assessed for those specific age groups.

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

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. Unsolicited adverse events, for this endpoint, were assessed in all subjects, in both groups.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one 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 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. Unsolicited AEs, for this endpoint, were assessed in subjects between 1-5 years of age, 6-12 years of age and 13-17 years of age.

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

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 days time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 days time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.

Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.

Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.

AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.

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

AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one 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. SAEs, for this endpoint, were assessed in all subjects, in both groups.

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one 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. SAEs, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.

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

Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in all subjects, in both groups.

The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.

Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.

The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.

A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on all subjects, in both groups.

The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.

A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on subjects aged 1-5 years, 6-12 years and 13-17 years.

The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.