This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Primary \& booster vaccination study to evaluate the immuno,reacto \& safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C \& Y-conjugate vaccine \& one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
388
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
GSK Investigational Site
Asse, Belgium
GSK Investigational Site
Drongen, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Maldegem, Belgium
GSK Investigational Site
Merelbeke, Belgium
GSK Investigational Site
Oudenaarde, Belgium
GSK Investigational Site
Sint-Amandsberg, Belgium
GSK Investigational Site
Cham, Bavaria, Germany
GSK Investigational Site
Kaufering, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
...and 16 more locations
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)
Time frame: One month after dose 3 (at study Month 3 - primary phase)
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
Time frame: One month after dose 3 (at study Month 3 - primary phase)
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
Time frame: One month after dose 3 (at study Month 3 - primary phase)
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)
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
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
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
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
Time frame: One month after the booster vaccination (at study Month 1 - booster phase)
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
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
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
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
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)
Time frame: Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
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)
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
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
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
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
Time frame: Prior to the booster vaccination (at study Month 0 - booster phase)
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rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
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)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
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
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
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
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Anti-tetanus Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
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.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
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)
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
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.
Time frame: Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
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)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
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
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
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
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
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
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
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
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
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
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-T Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Time frame: Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Anti-diphtheria Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
Time frame: One month after the third dose (at study Month 3 - primary phase)
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).
Time frame: One month after the third dose (at study Month 3 - primary phase)
Anti-poliovirus Types 1, 2, 3 Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-diphtheria Antibodies
Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
Time frame: One month after the third dose (at study Month 3 - primary phase)
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
Time frame: One month after the third dose (at study Month 3 - primary phase)
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.
Time frame: One month after the third dose (at study Month 3 - primary phase)
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Time frame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
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)).
Time frame: During the 8-day (Day 0-7) follow-up period (during the primary phase)
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.
Time frame: During the 31-day (Day 0-30) follow-up period (during the primary phase)
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.
Time frame: Over the full course of the primary phase (up to study Month 3 - primary phase)
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Time frame: During the 8-day (Day 0-7) follow-up period (during the booster phase)
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)).
Time frame: During the 8-day (Day 0-7) follow-up period (during the booster phase)
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.
Time frame: During the 31-day (Day 0-30) follow-up period (during the booster phase)
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.
Time frame: Over the full course of the booster phase (up to study Month 1 - booster phase)