The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.
The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,095
4- or 3-dose intramuscular injection
3-dose intramuscular injection
3-dose intramuscular injection
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.
The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
Time frame: One month after the final primary vaccination at Month 3
Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value
The cut-off value for rSBA-MenC titers was ≥ 1:8.
Time frame: One month after the final primary vaccination at Month 3
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination
Time frame: Pre-primary vaccination at Month 0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Pre-primary vaccination at Month 0
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
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4-dose intramuscular injection
4-dose intramuscular injection
GSK Investigational Site
Haabneeme, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tartu, Estonia
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, Germany
GSK Investigational Site
Berchtesgaden, Bavaria, Germany
GSK Investigational Site
Bindlach, Bavaria, Germany
GSK Investigational Site
Gilching, Bavaria, Germany
...and 34 more locations
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value
The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values
The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 8-day (Days 0-7) post-meningococcal booster vaccination period
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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.
Time frame: Within 31-days (Days 0-30) post-each primary vaccination dose
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 8-day (Days 0-7) post-Synflorix™ booster vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 8-day (Days 0-7) post-booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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.
Time frame: Within 31-days (Days 0-30) post-booster vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: Throughout the entire study (from Day 0 to Month 16)
Number of Subjects With Serious Adverse Events (SAEs)
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.
Time frame: From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.
Time frame: During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.
Time frame: From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16)