Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Hepatitis B, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
Conditions
Brief summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Detailed description
In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.
Interventions
BIOLOGICALGSK2202083A vaccine
Intramuscular, three doses
BIOLOGICAL10-valent pneumococcal vaccine (GSK 1024850A)
Intramuscular, three doses
BIOLOGICALInfanrix hexa™
Intramuscular, three doses
BIOLOGICALMenjugate®
Intramuscular, two doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination. * Born after a gestation period of 36 to 42 weeks inclusive. * Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations. * Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent/LAR of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, or planned administration during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Hib, pneumococcal and/or MenC disease. * History of seizures or progressive neurological disease. * 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. * Major congenital defects or serious chronic illness. 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 3 | 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 Complement (rSBA-MenC) | At Month 3 | A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC) | At Month 3 | A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL. |
| Anti-PSC Antibody Concentrations | At Months 0 and 3 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL. |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | At Month 3 | A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). |
| Anti-D and Anti-T Antibody Concentrations | At Month 3 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL. |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | At Month 3 | A seropositive subject was defined as a subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | At Months 0 and 3 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL. |
| Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | At Month 3 | A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration. |
| Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | At Month 3 | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. |
| Anti-HBs Antibody Concentrations | At Month 3 | Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis. |
| Anti-PRP Antibody Concentrations | At Months 0 and 3 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL. |
| Anti-polio Types 1, 2 and 3 Antibody Titers | At Month 3 | Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8. |
| Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | At Month 3 | A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
| Anti-pneumo Antibody Concentrations | At Month 3 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL. |
| Number of Seropositive Subjects for Anti-protein D (Anti-PD) | At Month 3 | A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL. |
| Anti-PD Antibody Concentrations | At Month 3 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL. |
| Number of Subjects With Any Solicited Local Symptoms | During the 8-day (Days 0-7) post-vaccination period after any vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 8-day (Days 0-7) post-vaccination period after any vaccination | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general 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-vaccination period after any vaccination | 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) | During the entire study period (from Month 0 to Month 3) | SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | At Month 3 | A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8. |
| Antibody Titers Against rSBA-MenC | At Months 0 and 3 | The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8. |
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 infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. | 141 |
| Infanrix Hexa + Menjugate Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. | 139 |
| Infanrix Hexa + Synflorix Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. | 141 |
| Total | 421 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Serious Adverse Event | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 2 |
Baseline characteristics
| Characteristic | Total | GSK2202083A + Synflorix Group | Infanrix Hexa + Menjugate Group | Infanrix Hexa + Synflorix Group |
|---|---|---|---|---|
| Age, Continuous | 8.63 Weeks STANDARD_DEVIATION 1.05 | 8.5 Weeks STANDARD_DEVIATION 0.98 | 8.7 Weeks STANDARD_DEVIATION 1.02 | 8.7 Weeks STANDARD_DEVIATION 1.13 |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 421 Participants | 141 Participants | 139 Participants | 141 Participants |
| Sex: Female, Male Female | 228 Participants | 74 Participants | 86 Participants | 68 Participants |
| Sex: Female, Male Male | 193 Participants | 67 Participants | 53 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 0 / 139 | 0 / 141 |
| other Total, other adverse events | 130 / 141 | 129 / 139 | 137 / 141 |
| serious Total, serious adverse events | 5 / 141 | 6 / 139 | 3 / 141 |
Outcome results
Primary
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)
A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC) | 124 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC) | 127 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC) | 10 Participants |
95% CI: [-5.19, 3.57]
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 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | 126 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | 123 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) | 130 Participants |
95% CI: [-4.21, 2.22]
Secondary
Antibody Titers Against rSBA-MenC
The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.
Time frame: At Months 0 and 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Antibody Titers Against rSBA-MenC | rSBA-MenC, Month 0 | 4.3 Titers |
| GSK2202083A + Synflorix Group | Antibody Titers Against rSBA-MenC | rSBA-MenC, Month 3 | 786.9 Titers |
| Infanrix Hexa + Menjugate Group | Antibody Titers Against rSBA-MenC | rSBA-MenC, Month 3 | 2674 Titers |
| Infanrix Hexa + Menjugate Group | Antibody Titers Against rSBA-MenC | rSBA-MenC, Month 0 | 4.8 Titers |
| Infanrix Hexa + Synflorix Group | Antibody Titers Against rSBA-MenC | rSBA-MenC, Month 0 | 4.2 Titers |
| Infanrix Hexa + Synflorix Group | Antibody Titers Against rSBA-MenC | rSBA-MenC, Month 3 | 6.1 Titers |
Secondary
Anti-D and Anti-T Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 1.671 IU/mL |
| GSK2202083A + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 3.966 IU/mL |
| Infanrix Hexa + Menjugate Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 1.437 IU/mL |
| Infanrix Hexa + Menjugate Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 1.595 IU/mL |
| Infanrix Hexa + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 1.421 IU/mL |
| Infanrix Hexa + Synflorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 2.458 IU/mL |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2202083A + Synflorix Group | Anti-HBs Antibody Concentrations | 1001.4 mIU/mL |
| Infanrix Hexa + Menjugate Group | Anti-HBs Antibody Concentrations | 1187.7 mIU/mL |
| Infanrix Hexa + Synflorix Group | Anti-HBs Antibody Concentrations | 1073.2 mIU/mL |
Secondary
Anti-PD Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2202083A + Synflorix Group | Anti-PD Antibody Concentrations | 1622.8 EL.U/mL |
| Infanrix Hexa + Menjugate Group | Anti-PD Antibody Concentrations | 63.3 EL.U/mL |
| Infanrix Hexa + Synflorix Group | Anti-PD Antibody Concentrations | 1561.6 EL.U/mL |
Secondary
Anti-pneumo Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 1 | 1.53 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 14 | 3.75 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 7F | 2.26 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 23F | 0.68 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 9V | 2.16 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 19F | 3.99 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 4 | 1.92 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 5 | 2.23 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 18C | 3.83 µg/mL |
| GSK2202083A + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 6B | 0.4 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 4 | 0.04 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 1 | 0.04 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 5 | 0.05 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 6B | 0.04 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 7F | 0.06 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 9V | 0.05 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 14 | 0.22 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 18C | 0.05 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 19F | 0.1 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 23F | 0.04 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 14 | 3.75 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 5 | 2.23 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 4 | 1.99 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 18C | 2.51 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 1 | 1.41 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 7F | 2.24 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 23F | 0.63 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 9V | 1.99 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 6B | 0.44 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-pneumo Antibody Concentrations | Anti-pneumo 19F | 3.86 µg/mL |
Secondary
Anti-polio Types 1, 2 and 3 Antibody Titers
Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 2 | 97.4 Titers |
| GSK2202083A + Synflorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 1 | 132.3 Titers |
| GSK2202083A + Synflorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 3 | 275.6 Titers |
| Infanrix Hexa + Menjugate Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 2 | 104.3 Titers |
| Infanrix Hexa + Menjugate Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 1 | 156.7 Titers |
| Infanrix Hexa + Menjugate Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 3 | 313.1 Titers |
| Infanrix Hexa + Synflorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 1 | 126.2 Titers |
| Infanrix Hexa + Synflorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 3 | 257.1 Titers |
| Infanrix Hexa + Synflorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio type 2 | 95.8 Titers |
Secondary
Anti-PRP Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.
Time frame: At Months 0 and 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, Month 0 | 0.197 µg/mL |
| GSK2202083A + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, Month 3 | 4.255 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-PRP Antibody Concentrations | Anti-PRP, Month 0 | 0.152 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-PRP Antibody Concentrations | Anti-PRP, Month 3 | 1.123 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, Month 0 | 0.176 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, Month 3 | 1.721 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 Months 0 and 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, Month 0 | 0.17 µg/mL |
| GSK2202083A + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, Month 3 | 19.15 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-PSC Antibody Concentrations | Anti-PSC, Month 0 | 0.17 µg/mL |
| Infanrix Hexa + Menjugate Group | Anti-PSC Antibody Concentrations | Anti-PSC, Month 3 | 18.1 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, Month 0 | 0.18 µg/mL |
| Infanrix Hexa + Synflorix Group | Anti-PSC Antibody Concentrations | Anti-PSC, Month 3 | 0.19 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 of ≥ 5 EL.U/mL.
Time frame: At Months 0 and 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, Month 3 | 36.1 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, Month 0 | 12.9 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, Month 0 | 5.3 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, Month 3 | 70.3 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, Month 0 | 3.5 EL.U/mL |
| GSK2202083A + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, Month 3 | 110.9 EL.U/mL |
| Infanrix Hexa + Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, Month 0 | 3.6 EL.U/mL |
| Infanrix Hexa + Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, Month 3 | 136.4 EL.U/mL |
| Infanrix Hexa + Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, Month 3 | 107.4 EL.U/mL |
| Infanrix Hexa + Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, Month 0 | 11.9 EL.U/mL |
| Infanrix Hexa + Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, Month 0 | 4.3 EL.U/mL |
| Infanrix Hexa + Menjugate Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, Month 3 | 41.7 EL.U/mL |
| Infanrix Hexa + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, Month 3 | 90.4 EL.U/mL |
| Infanrix Hexa + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, Month 3 | 37.6 EL.U/mL |
| Infanrix Hexa + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, Month 0 | 5.4 EL.U/mL |
| Infanrix Hexa + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, Month 0 | 13.2 EL.U/mL |
| Infanrix Hexa + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, Month 3 | 112.7 EL.U/mL |
| Infanrix Hexa + Synflorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, Month 0 | 3.8 EL.U/mL |
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 or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| 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-PRN | 126 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 | 127 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 | 127 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 | 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-PT | 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-FHA | 131 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN | 131 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA | 132 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT | 132 Participants |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 1 | 125 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 4 | 122 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 5 | 126 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 6B | 114 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 7F | 125 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 9V | 126 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 14 | 126 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 18C | 122 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 19F | 127 Participants |
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 23F | 123 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 19F | 88 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 1 | 37 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 9V | 37 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 7F | 56 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 4 | 21 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 23F | 34 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 18C | 52 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 5 | 44 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 14 | 106 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 6B | 28 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 18C | 126 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 6B | 117 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 7F | 128 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 9V | 126 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 19F | 127 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 14 | 128 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 1 | 124 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 23F | 124 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 4 | 127 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes | Anti-pneumo 5 | 126 Participants |
Secondary
Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)
A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC) | 124 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC) | 125 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC) | 8 Participants |
Secondary
Number of Seropositive Subjects for Anti-protein D (Anti-PD)
A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) | 126 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) | 18 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seropositive Subjects for Anti-protein D (Anti-PD) | 130 Participants |
Secondary
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL | 116 Participants |
| GSK2202083A + Synflorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL | 116 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL | 124 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL | 124 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL | 122 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL | 122 Participants |
Secondary
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)
A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | Anti-D | 126 Participants |
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | Anti-T | 126 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | Anti-T | 132 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | Anti-D | 132 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | Anti-T | 132 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) | Anti-D | 132 Participants |
Secondary
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3
A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 2 | 90 Participants |
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 1 | 91 Participants |
| GSK2202083A + Synflorix Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 3 | 90 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 2 | 101 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 1 | 103 Participants |
| Infanrix Hexa + Menjugate Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 3 | 102 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 1 | 92 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 3 | 91 Participants |
| Infanrix Hexa + Synflorix Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio type 2 | 91 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.
Time frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any drowsiness | 105 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any irritability | 108 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any loss of appetite | 72 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any fever | 53 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any fever | 38 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any drowsiness | 91 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any loss of appetite | 62 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With Any Solicited General Symptoms | Any irritability | 101 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any fever | 61 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any irritability | 113 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any loss of appetite | 72 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Any Solicited General Symptoms | Any drowsiness | 107 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any swelling | 64 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any redness | 83 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any pain | 66 Participants |
| Infanrix Hexa + Menjugate 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 pain | 70 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With Any Solicited Local Symptoms | Any redness | 81 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any swelling | 71 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any redness | 83 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Any Solicited Local Symptoms | Any pain | 85 Participants |
Secondary
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.
Time frame: At Month 3
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 112 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 116 Participants |
| GSK2202083A + Synflorix Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 121 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 123 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 124 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 123 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 123 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 120 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 122 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: During the entire study period (from Month 0 to Month 3)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 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-vaccination period after any vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A + Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 61 Participants |
| Infanrix Hexa + Menjugate Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 52 Participants |
| Infanrix Hexa + Synflorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 61 Participants |