Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis, Acellular Pertussis, Diphtheria, Neisseria Meningitidis
Conditions
Brief summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
Interventions
BIOLOGICALGSK2202083A vaccine
3 doses given at 2, 4 and 12 months of age
BIOLOGICALPrevenar 13®
3 co-administered doses
BIOLOGICALInfanrix hexa™
3 doses given at 2, 4 and 12 months of age
BIOLOGICALMenjugate®
3 co-administered doses
BIOLOGICALRotarix™
Oral, 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
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination. * Born after a gestation period of 36 to 42 weeks inclusive. * 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
* Use of any investigational or non-registered product other than the study vaccine(s) 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. * Child in care. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit 4. * 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth. * History of seizures or progressive neurological disease. * Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. * 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 vaccine(s). * 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 Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off | At Month 3 | The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). |
| Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off | At Month 3 | The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations for Anti-PRP. | At Month 3, Month 10 and Month 11. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL. |
| Titers for rSBA-MenC. | At Month 3, Month 10 and Month 11. | Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128. |
| Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | At Month 3, Month 10 and Month 11. | The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL). |
| Concentrations for Anti-T and Anti-D. | At Month 3, Month 10 and Month 11. | Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL. |
| Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | At Month 3, Month 10 and Month 11. | A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (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. |
| Concentrations for Anti-HBs. | At Month 3, Month 10 and Month 11. | A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (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. |
| Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | At Month 3, Month 10 and Month 11. | The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8. |
| Titers for Anti-polio 1, 2 and 3. | At Month 3, Month 10 and Month 11. | Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8. |
| Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | At Month 3, Month 10 and Month 11. | The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL). |
| Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | At Month 3, Month 10 and Month 11. | The anti-PRP antibody concentration cut-offs for this assay were ≥ 0.15 µg/mL and 1.0 µg/mL. Values concerning the cut-off of 0.15 µg/mL at Month 3 were listed for a primary outcome, hence they were not reported under this outcome. |
| Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. | At Month 11. | Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration |
| Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | At Month 3 and Month 11 | The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Concentrations for Anti-PNE Serotypes. | At Month 3 and Month 11 | Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL. |
| Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | At Month 11. | The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10. |
| Number of Subjects Reporting Any Solicited Local Symptoms. | During the 8-day (Days 0-7) post-vaccination period | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Solicited General Symptoms. | During the 8-day (Days 0-7) post-vaccination period | Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | Within the 31-day (Days 0-30) follow up period after vaccination | An unsolicited AE is 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs). | During the entire study period (Month 0 to Month 11) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination. |
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | At Month 3, Month 10 and Month 11. | Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL. |
| Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | At Month 3, Month 10 and Month 11. | The rSBA-MenC antibody titers cut-off for this assay were ≥ 1:8 and ≥ 1:128. Values concerning the cut-off of 1:8 at Month 3 were listed for a primary outcome, hence they were not reported under this outcome. |
Countries
Canada, France, Germany
Participant flow
Recruitment details
A total of 480 subjects were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| GSK2202083A Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. | 238 |
| Infanrix Hexa Group Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. | 242 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Eligibility Criteria | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | Non serious AEs | 1 | 0 |
| Overall Study | Other | 2 | 4 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | GSK2202083A Group | Infanrix Hexa Group | Total |
|---|---|---|---|
| Age, Continuous | 9.10 Weeks STANDARD_DEVIATION 1.15 | 9.20 Weeks STANDARD_DEVIATION 1.17 | 9.15 Weeks STANDARD_DEVIATION 1.16 |
| Race/Ethnicity, Customized African heritage/African American | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian-East Asian heritage | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian-South East Asian heritage | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Unspecified | 11 Participants | 12 Participants | 23 Participants |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 5 Participants | 8 Participants | 13 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 210 Participants | 216 Participants | 426 Participants |
| Sex: Female, Male Female | 108 Participants | 111 Participants | 219 Participants |
| Sex: Female, Male Male | 130 Participants | 131 Participants | 261 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 238 | 0 / 242 |
| other Total, other adverse events | 232 / 238 | 237 / 242 |
| serious Total, serious adverse events | 12 / 238 | 15 / 242 |
Outcome results
Primary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
The anti-PRP antibody concentration cut-off for this assay was 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 cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off | 204 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off | 188 Participants |
Primary
Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
Time frame: At Month 3
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A Group | Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off | 210 Participants |
| Infanrix Hexa Group | Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off | 219 Participants |
Secondary
Concentrations for Anti-HBs.
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (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, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A Group | Concentrations for Anti-HBs. | Anti-HBs at Month 3 | 701.6 mIU/mL |
| GSK2202083A Group | Concentrations for Anti-HBs. | Anti-HBs at Month 10 | 134.9 mIU/mL |
| GSK2202083A Group | Concentrations for Anti-HBs. | Anti-HBs at Month 11 | 3934.7 mIU/mL |
| Infanrix Hexa Group | Concentrations for Anti-HBs. | Anti-HBs at Month 3 | 897.8 mIU/mL |
| Infanrix Hexa Group | Concentrations for Anti-HBs. | Anti-HBs at Month 10 | 212.8 mIU/mL |
| Infanrix Hexa Group | Concentrations for Anti-HBs. | Anti-HBs at Month 11 | 4850.7 mIU/mL |
Secondary
Concentrations for Anti-PNE Serotypes.
Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.
Time frame: At Month 3 and Month 11
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 5 at Month 3 ≥ 0.2 | 1.83 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 1 at Month 11 ≥ 0.2 | 4.99 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 3 at Month 3 ≥ 0.2 | 1.16 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 3 at Month 11 ≥ 0.2 | 1.74 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 4 at Month 3 ≥ 0.2 | 1.40 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 4 at Month 11 ≥ 0.2 | 4.19 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 1 at Month 3 ≥ 0.2 | 1.66 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 5 at Month 11 ≥ 0.2 | 6.68 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6A at Month 3 ≥ 0.2 | 1.06 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6A at Month 11 ≥ 0.2 | 7.34 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6B at Month 3 ≥ 0.2 | 0.09 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6B at Month 11 ≥ 0.2 | 2.23 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 7F at Month 3 ≥ 0.2 | 2.72 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 7F at Month 11 ≥ 0.2 | 6.67 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 9V at Month 3 ≥ 0.2 | 1.36 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 9V at Month 11 ≥ 0.2 | 6.12 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 14 at Month 3 ≥ 0.2 | 3.03 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 14 at Month 11 ≥ 0.2 | 10.41 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 18C at Month 3 ≥ 0.2 | 1.81 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 18C at Month 11 ≥ 0.2 | 6.20 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19A at Month 3 ≥ 0.2 | 1.05 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19A at Month 11 ≥ 0.2 | 5.73 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19F at Month 3 ≥ 0.2 | 2.82 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19F at Month 11 ≥ 0.2 | 5.47 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 23F at Month 3 ≥ 0.2 | 0.40 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 23F at Month 11 ≥ 0.2 | 4.38 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 18C at Month 11 ≥ 0.2 | 5.91 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 1 at Month 3 ≥ 0.2 | 1.89 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 7F at Month 11 ≥ 0.2 | 6.47 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 1 at Month 11 ≥ 0.2 | 4.79 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 23F at Month 3 ≥ 0.2 | 0.54 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 3 at Month 3 ≥ 0.2 | 1.15 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 9V at Month 3 ≥ 0.2 | 1.42 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 3 at Month 11 ≥ 0.2 | 1.82 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19A at Month 3 ≥ 0.2 | 1.30 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 4 at Month 3 ≥ 0.2 | 1.55 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 9V at Month 11 ≥ 0.2 | 6.80 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 4 at Month 11 ≥ 0.2 | 4.43 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19F at Month 11 ≥ 0.2 | 5.70 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 5 at Month 3 ≥ 0.2 | 2.17 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 14 at Month 3 ≥ 0.2 | 2.96 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 5 at Month 11 ≥ 0.2 | 6.75 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19A at Month 11 ≥ 0.2 | 5.22 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6A at Month 3 ≥ 0.2 | 1.20 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 14 at Month 11 ≥ 0.2 | 7.50 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6A at Month 11 ≥ 0.2 | 7.96 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 23F at Month 11 ≥ 0.2 | 4.51 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6B at Month 3 ≥ 0.2 | 0.12 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 18C at Month 3 ≥ 0.2 | 2.08 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 6B at Month 11 ≥ 0.2 | 2.78 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 19F at Month 3 ≥ 0.2 | 3.36 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Serotypes. | Anti-PNE 7F at Month 3 ≥ 0.2 | 2.75 µg/mL |
Secondary
Concentrations for Anti-PRP.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A Group | Concentrations for Anti-PRP. | Anti-PRP at Month 3 | 1.594 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PRP. | Anti-PRP at Month 10 | 0.340 µg/mL |
| GSK2202083A Group | Concentrations for Anti-PRP. | Anti-PRP at Month 11 | 17.678 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PRP. | Anti-PRP at Month 3 | 0.671 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PRP. | Anti-PRP at Month 10 | 0.260 µg/mL |
| Infanrix Hexa Group | Concentrations for Anti-PRP. | Anti-PRP at Month 11 | 13.737 µg/mL |
Secondary
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Month 10 | 8.0 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Month 11 | 429.6 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Month 3 | 165.8 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Month 3 | 66.2 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Month 11 | 74.9 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Month 10 | 9.1 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Month 10 | 37.8 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Month 11 | 218.0 EL.U/mL |
| GSK2202083A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Month 3 | 47.4 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Month 11 | 242.9 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Month 3 | 49.3 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Month 10 | 8.3 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Month 11 | 86.1 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Month 3 | 172.3 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Month 10 | 39.7 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Month 11 | 451.2 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Month 3 | 74.5 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Month 10 | 11.0 EL.U/mL |
Secondary
Concentrations for Anti-T and Anti-D.
Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A Group | Concentrations for Anti-T and Anti-D. | Anti-D at Month 3 | 0.936 IU/mL |
| GSK2202083A Group | Concentrations for Anti-T and Anti-D. | Anti-D at Month 10 | 0.183 IU/mL |
| GSK2202083A Group | Concentrations for Anti-T and Anti-D. | Anti-D at Month 11 | 4.538 IU/mL |
| GSK2202083A Group | Concentrations for Anti-T and Anti-D. | Anti-T at Month 3 | 2.543 IU/mL |
| GSK2202083A Group | Concentrations for Anti-T and Anti-D. | Anti-T at Month 10 | 0.458 IU/mL |
| GSK2202083A Group | Concentrations for Anti-T and Anti-D. | Anti-T at Month 11 | 7.647 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-T and Anti-D. | Anti-T at Month 10 | 0.249 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-T and Anti-D. | Anti-D at Month 3 | 1.197 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-T and Anti-D. | Anti-T at Month 3 | 1.380 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-T and Anti-D. | Anti-D at Month 10 | 0.241 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-T and Anti-D. | Anti-T at Month 11 | 4.720 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-T and Anti-D. | Anti-D at Month 11 | 5.307 IU/mL |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time frame: During the entire study period (Month 0 to Month 11)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2202083A Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | 12 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | 15 Participants |
Secondary
Number of Subjects Reporting Any Solicited General Symptoms.
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any loss of appetite | 169 Participants |
| GSK2202083A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any drowsiness | 188 Participants |
| GSK2202083A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any fever | 165 Participants |
| GSK2202083A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any irritability | 208 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any fever | 167 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any drowsiness | 190 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any loss of appetite | 154 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any irritability | 207 Participants |
Secondary
Number of Subjects Reporting Any Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any pain | 155 Participants |
| GSK2202083A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any redness | 171 Participants |
| GSK2202083A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any swelling | 147 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any pain | 181 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any redness | 183 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any swelling | 163 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE is 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2202083A Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 148 Subjects |
| Infanrix Hexa Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 158 Subjects |
Secondary
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration
Time frame: At Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 183 Participants |
| GSK2202083A Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 191 Participants |
| GSK2202083A Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 185 Participants |
| Infanrix Hexa Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 185 Participants |
| Infanrix Hexa Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 190 Participants |
| Infanrix Hexa Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 186 Participants |
Secondary
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.
The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-D at Month 3 | 215 Participants |
| GSK2202083A Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-D at Month 10 | 143 Participants |
| GSK2202083A Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-D at Month 11 | 200 Participants |
| GSK2202083A Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-T at Month 3 | 216 Participants |
| GSK2202083A Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-T at Month 10 | 189 Participants |
| GSK2202083A Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-T at Month 11] | 200 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-T at Month 10 | 176 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-D at Month 3 | 222 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-T at Month 3 | 223 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-D at Month 10 | 169 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-T at Month 11] | 196 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off. | Anti-D at Month 11 | 196 Participants |
Secondary
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (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, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 10 mIU/mL at Month 3 | 204 Participants |
| GSK2202083A Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 10 mIU/mL at Month 10 | 182 Participants |
| GSK2202083A Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 10 mIU/mL at Month 11 | 194 Participants |
| GSK2202083A Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 100 mIU/mL at Month 3 | 190 Participants |
| GSK2202083A Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 100 mIU/mL at Month 10 | 118 Participants |
| GSK2202083A Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 100 mIU/mL at Month 11 | 187 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 100 mIU/mL at Month 10 | 146 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 10 mIU/mL at Month 3 | 215 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 100 mIU/mL at Month 3 | 207 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 10 mIU/mL at Month 10 | 190 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 100 mIU/mL at Month 11 | 194 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) | Anti-HBs ≥ 10 mIU/mL at Month 11 | 196 Participants |
Secondary
Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.
The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: At Month 3 and Month 11
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 3 ≥ 0.2 | 79 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 11 ≥ 0.05 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 11 ≥ 0.2 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 3 ≥ 0.2 | 75 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 3 ≥ 0.2 | 74 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 3 ≥ 0.05 | 81 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 11 ≥ 0.2 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 11 ≥ 0.2 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 3 ≥ 0.2 | 79 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 3 ≥ 0.2 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 11 ≥ 0.2 | 84 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 3 ≥ 0.2 | 70 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 3 ≥ 0.2 | 52 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 11 ≥ 0.2 | 84 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 11 ≥ 0.2 | 84 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 3 ≥ 0.05 | 87 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 11 ≥ 0.2 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 3 ≥ 0.2 | 20 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 3 ≥ 0.05 | 83 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 11 ≥ 0.05 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 11 ≥ 0.05 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 11 ≥ 0.2 | 83 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 3 ≥ 0.05 | 82 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 3 ≥ 0.2 | 82 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 3 ≥ 0.2 | 83 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 3 ≥ 0.05 | 79 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 11 ≥ 0.2 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 3 ≥ 0.05 | 79 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 11 ≥ 0.2 | 83 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 3 ≥ 0.2 | 77 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 3 ≥ 0.05 | 54 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 3 ≥ 0.05 | 73 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 11 ≥ 0.05 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 11 ≥ 0.2 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 3 ≥ 0.05 | 84 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 3 ≥ 0.2 | 78 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 3 ≥ 0.2 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 3 ≥ 0.05 | 80 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 3 ≥ 0.05 | 83 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 11 ≥ 0.2 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 3 ≥ 0.05 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 11 ≥ 0.2 | 85 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 11 ≥ 0.05 | 86 Participants |
| GSK2202083A Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 3 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 3 ≥ 0.05 | 93 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 3 ≥ 0.05 | 93 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 3 ≥ 0.05 | 92 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 11 ≥ 0.05 | 82 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 3 ≥ 0.05 | 89 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 11 ≥ 0.05 | 82 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 3 ≥ 0.2 | 94 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 3 ≥ 0.2 | 93 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 3 ≥ 0.2 | 93 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 3 ≥ 0.2 | 89 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 3 ≥ 0.2 | 86 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 3 ≥ 0.2 | 27 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 11 ≥ 0.2 | 82 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 3 ≥ 0.2 | 93 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 3 ≥ 0.2 | 89 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 3 ≥ 0.2 | 92 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 11 ≥ 0.2 | 82 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 3 ≥ 0.2 | 89 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 18C at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 3 ≥ 0.2 | 91 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19A at Month 11 ≥ 0.2 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 3 ≥ 0.2 | 92 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 19F at Month 11 ≥ 0.2 | 82 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 3 ≥ 0.2 | 76 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 23F at Month 11 ≥ 0.2 | 82 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 3 ≥ 0.05 | 94 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 1 at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 3 ≥ 0.05 | 93 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 3 at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 3 ≥ 0.05 | 94 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 4 at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 3 ≥ 0.05 | 91 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 5 at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 3 ≥ 0.05 | 91 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6A at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 3 ≥ 0.05 | 72 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 6B at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 3 ≥ 0.05 | 93 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 7F at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 3 ≥ 0.05 | 91 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 9V at Month 11 ≥ 0.05 | 83 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs. | Anti-PNE 14 at Month 3 ≥ 0.05 | 93 Participants |
Secondary
Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.
The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 1 at Month 10 | 82 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 2 at Month 11 | 188 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 2 at Month 3 | 159 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 3 at Month 3 | 169 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 1 at Month 11 | 182 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 3 at Month 10 | 96 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 2 at Month 10 | 87 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 3 at Month 11 | 188 Participants |
| GSK2202083A Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 1 at Month 3 | 168 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 3 at Month 11 | 185 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 1 at Month 3 | 183 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 1 at Month 10 | 98 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 1 at Month 11 | 186 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 2 at Month 3 | 160 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 2 at Month 10 | 96 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 2 at Month 11 | 186 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 3 at Month 3 | 188 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off. | Anti-polio 3 at Month 10 | 108 Participants |
Secondary
Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.
The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.
Time frame: At Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥2 | 195 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥4 | 191 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥6 | 189 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥8 | 179 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥10 | 173 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥2 | 189 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥4 | 177 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥6 | 160 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥8 | 148 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥10 | 135 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥6 | 182 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥2 | 189 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥2 | 185 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥4 | 186 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥10 | 178 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥6 | 176 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥4 | 185 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥8 | 170 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | rSBA-MenC ≥8 | 180 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution. | Anti-PRP ≥10 | 166 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs
The anti-PRP antibody concentration cut-offs for this assay were ≥ 0.15 µg/mL and 1.0 µg/mL. Values concerning the cut-off of 0.15 µg/mL at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 0.15, Month 10 | 145 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 1.0, Month 10 | 32 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 0.15, Month 11 | 200 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 1.0 , Month 11 | 198 Participants |
| GSK2202083A Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 1.0, Month 3 | 134 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 1.0 , Month 11 | 185 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 1.0, Month 3 | 82 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 0.15, Month 10 | 123 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 0.15, Month 11 | 196 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs | Anti-PRP ≥ 1.0, Month 10 | 26 Participants |
Secondary
Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs
The rSBA-MenC antibody titers cut-off for this assay were ≥ 1:8 and ≥ 1:128. Values concerning the cut-off of 1:8 at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:8, Month 10 | 178 Participants |
| GSK2202083A Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:128, Month 10 | 119 Participants |
| GSK2202083A Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:8, Month 11 | 198 Participants |
| GSK2202083A Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:128, Month 11 | 192 Participants |
| GSK2202083A Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:128, Month 3 | 201 Participants |
| Infanrix Hexa Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:128, Month 11 | 196 Participants |
| Infanrix Hexa Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:128, Month 3 | 219 Participants |
| Infanrix Hexa Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:8, Month 10 | 154 Participants |
| Infanrix Hexa Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:8, Month 11 | 196 Participants |
| Infanrix Hexa Group | Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs | rSBA-MenC ≥ 1:128, Month 10 | 92 Participants |
Secondary
Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.
The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PT at Month 10 | 136 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-FHA at Month 11 | 199 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-FHA at Month 3 | 216 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PRN at Month 3 | 216 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PT at Month 11 | 199 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PRN at Month 10 | 129 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-FHA at Month 10 | 196 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PRN at Month 11 | 200 Participants |
| GSK2202083A Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PT at Month 3 | 217 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PRN at Month 11 | 198 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PT at Month 3 | 223 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PT at Month 10 | 153 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PT at Month 11 | 195 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-FHA at Month 3 | 222 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-FHA at Month 10 | 195 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-FHA at Month 11 | 196 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PRN at Month 3 | 222 Participants |
| Infanrix Hexa Group | Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off. | Anti-PRN at Month 10 | 142 Participants |
Secondary
Titers for Anti-polio 1, 2 and 3.
Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 at Month 11 | 506.5 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 at Month 3 | 37.5 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 at Month 10 | 9.3 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 at Month 11 | 268.4 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 at Month 3 | 28.1 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 at Month 10 | 10.0 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 at Month 11 | 379.0 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 at Month 3 | 70.0 titers |
| GSK2202083A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 at Month 10 | 13.0 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 at Month 3 | 91.9 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 at Month 10 | 10.5 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 at Month 3 | 52.1 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 at Month 11 | 541.9 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 at Month 10 | 11.2 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 at Month 11 | 429.2 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 at Month 11 | 313.7 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 at Month 10 | 15.1 titers |
| Infanrix Hexa Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 at Month 3 | 30.6 titers |
Secondary
Titers for rSBA-MenC.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.
Time frame: At Month 3, Month 10 and Month 11.
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2202083A Group | Titers for rSBA-MenC. | rSBA-MenC at Month 3 | 1119.5 titers |
| GSK2202083A Group | Titers for rSBA-MenC. | rSBA-MenC at Month 10 | 131.1 titers |
| GSK2202083A Group | Titers for rSBA-MenC. | rSBA-MenC at Month 11 | 2653.8 titers |
| Infanrix Hexa Group | Titers for rSBA-MenC. | rSBA-MenC at Month 3 | 3200.5 titers |
| Infanrix Hexa Group | Titers for rSBA-MenC. | rSBA-MenC at Month 10 | 73.7 titers |
| Infanrix Hexa Group | Titers for rSBA-MenC. | rSBA-MenC at Month 11 | 6028.4 titers |