Tetanus, Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis, Acellular Pertussis, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
Conditions
Keywords
booster vaccination, combined vaccine
Brief summary
The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).
Interventions
BIOLOGICALGSK2202083A vaccine
Intramuscular, one dose.
BIOLOGICALInfanrix hexa™
Intramuscular, one dose.
BIOLOGICALMenjugate™
Intramuscular, one dose.
BIOLOGICALNeisVac-C™
Intramuscular, one dose.
BIOLOGICALSynflorix™
Intramuscular, one dose.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol. * Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157). * A male or female between, and including, 12 and 18 months of age at the time of booster vaccination. * Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. * Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period. * Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose. * Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product. * Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * The following adverse event having occurred after previous administration of DTP vaccine: * Encephalopathy. * Temperature of \>= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause. * Collapse or shock-like state within 48 hours of vaccination. * Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting \>= 3 hours. * Seizures with or without fever occurring within 3 days of vaccination. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | At Month 1, post-booster dose | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL). |
| Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC) | At Month 1, post-booster dose | A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | At Month 0 and Month 1, before and one month after booster dose | The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL. |
| Anti-PRP Antibody Concentrations | At Month 0 and Month 1, before and one month after booster dose | Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL. |
| Number of Seroprotected Subjects Against rSBA-MenC | At Month 0, before the booster dose | A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8. |
| Number of Seropositive Subjects for Anti-rSBA-MenC | At Month 0 and Month 1, before and one month after booster dose | A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128. |
| Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | At Month 0 and Month 1, before and one month after booster dose | The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL. |
| Anti-PSC Antibody Concentrations | At Month 0 and Month 1, before and one month after booster dose | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL. |
| Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | At Month 0 and Month 1, before and one month after booster dose | A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). |
| Anti-D and Anti-T Antibody Concentrations | At Month 0 and Month 1, before and one month after booster dose | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL. |
| Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | At Month 0 and Month 1, before and one month after booster dose | The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL. |
| Anti-rSBA-MenC Antibody Titres | At Month 0 and Month 1, before and one month after booster dose | Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8. |
| Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | At Month 0 and Month 1, before and one month after booster dose | A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8. |
| Anti-poliovirus Types 1, 2 and 3 Antibody Titres | At Month 0 and Month 1, before and one month after booster dose | Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8. |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | At Month 0 and Month 1, before and one month after booster dose | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | At Month 0 and Month 1, before and one month after booster dose | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL. |
| Number of Subjects With Any Solicited Local Symptoms | During the 8-day (Days 0-7) post-booster period | Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 8-day (Days 0-7) post-booster period | Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-booster period | An unsolicited AE was any AE (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 With Serious Adverse Events (SAEs) | After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1) | SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Anti-HBs Antibody Concentrations | At Month 0 and Month 1, before and after booster dose | Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. |
| Number of Seropositive Subjects for Anti-PRP | At Month 0, before the booster dose | A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. |
Countries
Poland
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK2202083A + Synflorix Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | 137 |
| Infanrix Hexa/Menjugate Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | 133 |
| Infanrix Hexa/NeisVac-C + Synflorix Group Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. | 121 |
| Total | 391 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK2202083A + Synflorix Group | Infanrix Hexa/Menjugate Group | Infanrix Hexa/NeisVac-C + Synflorix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 13.7 Months STANDARD_DEVIATION 0.71 | 13.8 Months STANDARD_DEVIATION 0.73 | 13.7 Months STANDARD_DEVIATION 0.76 | 13.73 Months STANDARD_DEVIATION 0.73 |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 137 Participants | 133 Participants | 121 Participants | 391 Participants |
| Sex: Female, Male Female | 71 Participants | 82 Participants | 56 Participants | 209 Participants |
| Sex: Female, Male Male | 66 Participants | 51 Participants | 65 Participants | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 133 | 0 / 121 |
| other Total, other adverse events | 114 / 137 | 114 / 133 | 102 / 121 |
| serious Total, serious adverse events | 3 / 137 | 2 / 133 | 2 / 121 |
Outcome results
Primary
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)
A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.
Time frame: At Month 1, post-booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC) | 131 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC) | 124 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC) | 114 Participants |
Comparison: Difference between groups for rSBA-MenC ≥1:895% CI: [-3.27, 2.86]
Comparison: Difference between groups for rSBA-MenC ≥1:895% CI: [-3.02, 2.86]
Primary
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).
Time frame: At Month 1, post-booster dose
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | 132 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | 126 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | 114 Participants |
Comparison: Difference in percentage anti-PRP ≥ 0.15 μg/mL95% CI: [-3.27, 2.84]
Secondary
Anti-D and Anti-T Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.349 IU/mL |
| GSK2202083A + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 6.166 IU/mL |
| GSK2202083A + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.895 IU/mL |
| GSK2202083A + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 11.945 IU/mL |
| Infanrix Hexa/Menjugate Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 5.351 IU/mL |
| Infanrix Hexa/Menjugate Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.316 IU/mL |
| Infanrix Hexa/Menjugate Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.316 IU/mL |
| Infanrix Hexa/Menjugate Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 7.351 IU/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 11.638 IU/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 6.02 IU/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.567 IU/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.311 IU/mL |
Secondary
Anti-HBs Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time frame: At Month 0 and Month 1, before and after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 295.1 mIU/mL |
| GSK2202083A + Synflorix Group | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 6390.7 mIU/mL |
| Infanrix Hexa/Menjugate Group | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 387.6 mIU/mL |
| Infanrix Hexa/Menjugate Group | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 8465 mIU/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 330.4 mIU/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 6840.3 mIU/mL |
Secondary
Anti-poliovirus Types 1, 2 and 3 Antibody Titres
Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 3, M0 | 43.7 Titers |
| GSK2202083A + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 1, M0 | 35.1 Titers |
| GSK2202083A + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 1, M1 | 870.5 Titers |
| GSK2202083A + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 2, M1 | 1179.1 Titers |
| GSK2202083A + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 3, M1 | 1493.3 Titers |
| GSK2202083A + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 2, M0 | 34.9 Titers |
| Infanrix Hexa/Menjugate Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 2, M0 | 46.2 Titers |
| Infanrix Hexa/Menjugate Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 2, M1 | 1483.6 Titers |
| Infanrix Hexa/Menjugate Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 3, M0 | 51.6 Titers |
| Infanrix Hexa/Menjugate Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 1, M0 | 48.3 Titers |
| Infanrix Hexa/Menjugate Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 3, M1 | 1832.9 Titers |
| Infanrix Hexa/Menjugate Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 1, M1 | 1203 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 3, M0 | 48.5 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 2, M0 | 38.2 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 3, M1 | 1416.8 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 1, M1 | 896.7 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 2, M1 | 1143.8 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-polio 1, M0 | 37 Titers |
Secondary
Anti-PRP Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 25.449 μg/mL |
| GSK2202083A + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.601 μg/mL |
| Infanrix Hexa/Menjugate Group | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 24.862 μg/mL |
| Infanrix Hexa/Menjugate Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.315 μg/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 25.943 μg/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.368 μg/mL |
Secondary
Anti-PSC Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, M1 | 6.91 μg/mL |
| GSK2202083A + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, M0 | 1.98 μg/mL |
| Infanrix Hexa/Menjugate Group | Anti-PSC Antibody Concentrations | Anti-PSC, M1 | 21.75 μg/mL |
| Infanrix Hexa/Menjugate Group | Anti-PSC Antibody Concentrations | Anti-PSC, M0 | 0.76 μg/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, M1 | 17.7 μg/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, M0 | 0.15 μg/mL |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 7.7 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M1 | 50.6 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M1 | 265.3 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 8.8 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M1 | 216.8 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 24.3 EL.U/mL |
| Infanrix Hexa/Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M1 | 339.6 EL.U/mL |
| Infanrix Hexa/Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 8.9 EL.U/mL |
| Infanrix Hexa/Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 30.4 EL.U/mL |
| Infanrix Hexa/Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 12.7 EL.U/mL |
| Infanrix Hexa/Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M1 | 66.3 EL.U/mL |
| Infanrix Hexa/Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M1 | 319.8 EL.U/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 25.7 EL.U/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M1 | 325.2 EL.U/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M1 | 277.9 EL.U/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 7.1 EL.U/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M1 | 61.8 EL.U/mL |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 11 EL.U/mL |
Secondary
Anti-rSBA-MenC Antibody Titres
Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-rSBA-MenC Antibody Titres | Anti-rSBA-MenC, M0 | 148.8 Titers |
| GSK2202083A + Synflorix Group | Anti-rSBA-MenC Antibody Titres | Anti-rSBA-MenC, M1 | 2703.4 Titers |
| Infanrix Hexa/Menjugate Group | Anti-rSBA-MenC Antibody Titres | Anti-rSBA-MenC, M0 | 55.6 Titers |
| Infanrix Hexa/Menjugate Group | Anti-rSBA-MenC Antibody Titres | Anti-rSBA-MenC, M1 | 7701.8 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-rSBA-MenC Antibody Titres | Anti-rSBA-MenC, M0 | 5.4 Titers |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Anti-rSBA-MenC Antibody Titres | Anti-rSBA-MenC, M1 | 2320.4 Titers |
Secondary
Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)
A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-D, M0 | 129 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-D, M1 | 132 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-T, M0 | 133 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-T, M1 | 132 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-T, M1 | 126 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-D, M0 | 115 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-T, M0 | 118 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-D, M1 | 126 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-T, M1 | 114 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-D, M1 | 114 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-T, M0 | 111 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | Anti-D, M0 | 108 Participants |
Secondary
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M0 | 98 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M1 | 133 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M0 | 131 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M1 | 132 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M0 | 100 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M1 | 132 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M1 | 126 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M0 | 97 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M1 | 126 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M0 | 109 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M1 | 126 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M0 | 122 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M1 | 114 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M0 | 111 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M1 | 113 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M1 | 114 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M0 | 84 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M0 | 94 Participants |
Secondary
Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3
A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 2, M1 | 113 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 3, M0 | 94 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 1, M1 | 113 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 2, M0 | 93 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 3, M1 | 113 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 1, M0 | 96 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 1, M1 | 99 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 2, M0 | 95 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 2, M1 | 100 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 1, M0 | 96 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 3, M0 | 94 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 3, M1 | 100 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 1, M0 | 79 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 3, M1 | 95 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 3, M0 | 80 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 2, M0 | 80 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 1, M1 | 94 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-polio 2, M1 | 94 Participants |
Secondary
Number of Seropositive Subjects for Anti-PRP
A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.
Time frame: At Month 0, before the booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-PRP | 131 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-PRP | 89 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-PRP | 88 Participants |
Secondary
Number of Seropositive Subjects for Anti-rSBA-MenC
A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-rSBA-MenC | Anti-rSBA-MenC, M0 | 87 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-rSBA-MenC | Anti-rSBA-MenC, M1 | 130 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-rSBA-MenC | Anti-rSBA-MenC, M0 | 46 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seropositive Subjects for Anti-rSBA-MenC | Anti-rSBA-MenC, M1 | 124 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-rSBA-MenC | Anti-rSBA-MenC, M0 | 3 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seropositive Subjects for Anti-rSBA-MenC | Anti-rSBA-MenC, M1 | 114 Participants |
Secondary
Number of Seroprotected Subjects Against rSBA-MenC
A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.
Time frame: At Month 0, before the booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects Against rSBA-MenC | 117 Participants |
| Infanrix Hexa/Menjugate Group | Number of Seroprotected Subjects Against rSBA-MenC | 92 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Seroprotected Subjects Against rSBA-MenC | 10 Participants |
Secondary
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values
The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 100 mIU/mL, M1 | 123 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 3.3 mIU/mL, M1 | 125 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 100 mIU/mL, M0 | 99 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 10 mIU/mL, M1 | 125 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 3.3 mIU/mL, M0 | 123 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 10 mIU/mL, M0 | 121 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 3.3 mIU/mL, M0 | 120 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 10 mIU/mL, M0 | 119 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 100 mIU/mL, M0 | 108 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 3.3 mIU/mL, M1 | 114 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 10 mIU/mL, M1 | 114 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 100 mIU/mL, M1 | 113 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 10 mIU/mL, M1 | 109 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 100 mIU/mL, M0 | 90 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 3.3 mIU/mL, M0 | 104 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 100 mIU/mL, M1 | 109 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 3.3 mIU/mL, M1 | 111 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values | Anti-HBs ≥ 10 mIU/mL, M0 | 102 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off
The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | Anti-PRP, M0 | 32 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | Anti-PRP, M1 | 132 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | Anti-PRP, M0 | 22 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | Anti-PRP, M1 | 126 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | Anti-PRP, M0 | 15 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off | Anti-PRP, M1 | 114 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-booster period
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 40 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 65 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 31 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature (Axillary) | 34 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature (Axillary) | 30 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 39 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 32 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 65 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature (Axillary) | 31 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 66 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 43 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 39 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.
Time frame: During the 8-day (Days 0-7) post-booster period
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 69 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 44 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 50 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 77 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 68 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 58 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 58 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 50 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 69 Participants |
Secondary
Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values
The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.
Time frame: At Month 0 and Month 1, before and one month after booster dose
Population: The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 2 μg/mL, M0 | 72 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M0 | 133 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M1 | 134 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 2 μg/mL, M1 | 129 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 2 μg/mL, M0 | 21 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M1 | 125 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 2 μg/mL, M1 | 125 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M0 | 101 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 2 μg/mL, M1 | 114 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M0 | 0 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M1 | 114 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values | Anti-PSC ≥ 2 μg/mL, M0 | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE was any AE (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 (Days 0-30) post-booster period
Population: The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 45 Participants |
| Infanrix Hexa/Menjugate Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 29 Participants |
| Infanrix Hexa/NeisVac-C + Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 35 Participants |