Number of Subjects With Solicited Local Symptoms, Overall
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.
Number of Subjects With Solicited Local Symptoms, by Age Stratum
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.
Number of Subjects With Solicited General Symptoms, Overall
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.
Number of Subjects With Solicited General Symptoms, by Age Stratum
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.
Number of Subjects With Unsolicited Adverse Events (AEs), Overall
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.
Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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.
Number of Subjects With Adverse Events of Specific Interest (AESI), Overall
AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.
Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum
AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.
Number of Subjects With Serious Adverse Events, Overall
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.
Number of Subjects With Serious Adverse Events, by Age Stratum
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.