Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Anti-tetanus Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.
Number of Seroprotected Subjects for Anti-tetanus Antibodies
Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)
Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128
rSBA-MenC antibody titre cut-off value assessed was ≥1:128
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128
rSBA-MenY antibody titre cut-off value assessed was ≥1:128
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).
Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL
Anti-T Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Anti-diphtheria Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).
Anti-poliovirus Types 1, 2, 3 Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Number of Seroprotected Subjects for Anti-diphtheria Antibodies
Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies
Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8
Number of Subjects With Vaccine Response to PT, FHA and PRN
Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.