Neisseria Meningitidis, Haemophilus Influenzae Type b
Conditions
Keywords
combined, Vaccines
Brief summary
The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.
Detailed description
This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.
Interventions
BIOLOGICALGSK2197870A
3 doses given at 2, 3 and 4 months of age
BIOLOGICALPrevenar™
3 co-administered doses, intramuscular into right thigh
BIOLOGICALMenitorix™
1 booster dose at 12 months of age
BIOLOGICALPediacel™
3 doses given at 2, 3 and 4 months of age
BIOLOGICALMenjugate™
2 doses given at 3 and 4 months of age
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy the following criteria at study entry: * A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Born after 36 to 42 weeks of gestation. * Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: * 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. For corticosteroids, this will mean prednisone, or equivalent, \>= 0.5 mg/kg/day. Inhaled and topical steroids are allowed. * 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 vaccination, 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, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease. * History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of allergic disease or reactions 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 and no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP). | At Month 3 | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). |
| Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) | At Month 2 and Month 3. | A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off. | At Month 3 | The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL). |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | At Month 2 and Month 3. | The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL. |
| Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | At Month 3. | A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). |
| Number of Seropositive Subjects Against 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 vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL). |
| Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | At Month 3. | A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8. |
| Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | At Month 3 | A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F. |
| Concentrations for Anti-PRP. | At Month 3. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL. |
| Titers for rSBA-MenC. | At Month 2 and Month 3. | Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8. |
| Concentrations for Anti-PSC. | At Month 2 and Month 3. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL. |
| Concentrations for Anti-T and Anti-D. | At Month 3. | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. |
| Concentrations for Anti-PNE Serotypes. | At Month 3. | Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL. |
| Number of Seroprotected Subjects for Anti-PRP. | At Month 10 and Month 11. | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). |
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | At Month 3. | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL. |
| Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | At Month 10 and Month 11. | The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL. |
| Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | At Month 10. | A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay). |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | At Month 10. | A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL). |
| Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | At Month 10. | A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8. |
| Number of Subjects With a Booster Response to rSBA-MenC Antibodies. | At Month 11 | Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster. |
| Number of Subjects With a Booster Response to Anti-PRP Antibodies. | At Month 11 | Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster. |
| Number of Subjects With a Booster Response to Anti-PSC Antibodies. | At Month 11 | Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster. |
| Number of Subjects Reporting Any Solicited Local Symptoms. | During the 8-day (Days 0-7) | 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) | Solicited general symptoms assessed were drowsiness, irritability, 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 or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination. |
| Number of Seropositive Subjects Against rSBA-MenC. | At Month 10 and Month 11. | A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8. |
| Titers for Anti-polio 1, 2 and 3. | At Month 3. | Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 284 subjects were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| GSK2197870A Group Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2 and a booster dose of Menitorix vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh. | 142 |
| Pediacel Group Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel vaccine at Months 0, 1 and 2, 2 doses of Prevenar vaccine at Months 0 and 2, 2 doses of Menjugate vaccine at Months 1 and 2 and a booster dose of Menitorix at Month 10. All vaccines were administered intramuscularly. Pediacel and Menitorix vaccines were administered in the right upper anterolateral thigh and Prevenar vaccine in the left upper anterolateral thigh and Menjugate vaccine in the left lower anterolateral thigh. | 142 |
| Total | 284 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Prior to Booster | Lost to Follow-up | 1 | 0 |
| Prior to Booster | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | GSK2197870A Group | Total | Pediacel Group |
|---|---|---|---|
| Age, Continuous | 11.8 weeks STANDARD_DEVIATION 0.39 | 11.85 weeks STANDARD_DEVIATION 0.38 | 11.9 weeks STANDARD_DEVIATION 0.36 |
| Race/Ethnicity, Customized African Heritage/African American | 2 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 17 Participants | 4 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Caucasian/European Heritage | 119 Participants | 251 Participants | 130 Participants |
| Sex: Female, Male Female | 59 Participants | 137 Participants | 78 Participants |
| Sex: Female, Male Male | 83 Participants | 147 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 141 / 142 | 141 / 142 |
| serious Total, serious adverse events | 9 / 142 | 6 / 142 |
Outcome results
Primary
Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
Time frame: At Month 2 and Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2197870A Group | Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) | rSBA-MenC at Month 2 [N=109;111] | 104 Participants |
| GSK2197870A Group | Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) | rSBA-MenC at Month 3 [N=105;113] | 101 Participants |
| Pediacel Group | Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) | rSBA-MenC at Month 2 [N=109;111] | 109 Participants |
| Pediacel Group | Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) | rSBA-MenC at Month 3 [N=105;113] | 113 Participants |
Primary
Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: At Month 3
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP). | 108 Participants |
| Pediacel Group | Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP). | 111 Participants |
Secondary
Concentrations for Anti-PNE Serotypes.
Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 9V [N=47;51] | 2.56 µg/mL |
| GSK2197870A Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 18C [N=46;52] | 2.26 µg/mL |
| GSK2197870A Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 6B [N=46;52] | 0.12 µg/mL |
| GSK2197870A Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 19F [N=47;52] | 3.00 µg/mL |
| GSK2197870A Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 14 [N=47;52] | 3.78 µg/mL |
| GSK2197870A Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 23F [N=47;52] | 0.58 µg/mL |
| GSK2197870A Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 4 [N=47;52] | 2.56 µg/mL |
| Pediacel Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 23F [N=47;52] | 0.89 µg/mL |
| Pediacel Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 4 [N=47;52] | 2.18 µg/mL |
| Pediacel Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 6B [N=46;52] | 0.12 µg/mL |
| Pediacel Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 9V [N=47;51] | 1.85 µg/mL |
| Pediacel Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 14 [N=47;52] | 2.71 µg/mL |
| Pediacel Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 18C [N=46;52] | 2.74 µg/mL |
| Pediacel Group | Concentrations for Anti-PNE Serotypes. | Anti- PNE 19F [N=47;52] | 3.15 µg/mL |
Secondary
Concentrations for Anti-PRP.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK2197870A Group | Concentrations for Anti-PRP. | 4.347 µg/mL |
| Pediacel Group | Concentrations for Anti-PRP. | 4.347 µg/mL |
Secondary
Concentrations for Anti-PRP.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.
Time frame: At Month 10 and Month 11.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-PRP. | Anti-PRP at Month 10 [N=89;98] | 0.423 µg /mL |
| GSK2197870A Group | Concentrations for Anti-PRP. | Anti-PRP at Month 11 [N=98;112] | 66.697 µg /mL |
| Pediacel Group | Concentrations for Anti-PRP. | Anti-PRP at Month 10 [N=89;98] | 0.574 µg /mL |
| Pediacel Group | Concentrations for Anti-PRP. | Anti-PRP at Month 11 [N=98;112] | 26.899 µg /mL |
Secondary
Concentrations for Anti-PSC.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
Time frame: At Month 10 and Month 11.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-PSC. | Anti-PSC at Month 11 [N=100;111] | 6.15 µg /mL |
| GSK2197870A Group | Concentrations for Anti-PSC. | Anti-PSC at Month 10 [N=86;97] | 0.94 µg /mL |
| Pediacel Group | Concentrations for Anti-PSC. | Anti-PSC at Month 10 [N=86;97] | 0.87 µg /mL |
| Pediacel Group | Concentrations for Anti-PSC. | Anti-PSC at Month 11 [N=100;111] | 2.88 µg /mL |
Secondary
Concentrations for Anti-PSC.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.
Time frame: At Month 2 and Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-PSC. | Anti-PSC at Month 2 [N=113;115] | 18.20 µg/mL |
| GSK2197870A Group | Concentrations for Anti-PSC. | Anti-PSC at Month 3 [N=108;114] | 15.10 µg/mL |
| Pediacel Group | Concentrations for Anti-PSC. | Anti-PSC at Month 2 [N=113;115] | 10.77 µg/mL |
| Pediacel Group | Concentrations for Anti-PSC. | Anti-PSC at Month 3 [N=108;114] | 17.29 µg/mL |
Secondary
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT [N=107;117] | 45.4 EL.U/mL |
| GSK2197870A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA [N=106;119] | 234.4 EL.U/mL |
| GSK2197870A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN [N=108;120] | 121.6 EL.U/mL |
| Pediacel Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT [N=107;117] | 45.1 EL.U/mL |
| Pediacel Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA [N=106;119] | 204.9 EL.U/mL |
| Pediacel Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN [N=108;120] | 49.9 EL.U/mL |
Secondary
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.
Time frame: At Month 10.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT [N=89;100] | 7.3 EL.U/mL |
| GSK2197870A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA [N=89;99] | 35.3 EL.U/mL |
| GSK2197870A Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN [N=89;100] | 15.0 EL.U/mL |
| Pediacel Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT [N=89;100] | 9.8 EL.U/mL |
| Pediacel Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA [N=89;99] | 48.8 EL.U/mL |
| Pediacel Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN [N=89;100] | 9.6 EL.U/mL |
Secondary
Concentrations for Anti-T and Anti-D.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
Time frame: At Month 10.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-T and Anti-D. | Anti-T ≥ 0.1 IU/mL [N=89;98] | 0.428 IU/mL |
| GSK2197870A Group | Concentrations for Anti-T and Anti-D. | Anti-D ≥ 0.1 IU/mL [N=89;98] | 0.249 IU/mL |
| GSK2197870A Group | Concentrations for Anti-T and Anti-D. | Anti-D ≥ 0.016 IU/mL [N=16;3] | 0.015 IU/mL |
| Pediacel Group | Concentrations for Anti-T and Anti-D. | Anti-T ≥ 0.1 IU/mL [N=89;98] | 0.260 IU/mL |
| Pediacel Group | Concentrations for Anti-T and Anti-D. | Anti-D ≥ 0.1 IU/mL [N=89;98] | 0.385 IU/mL |
| Pediacel Group | Concentrations for Anti-T and Anti-D. | Anti-D ≥ 0.016 IU/mL [N=16;3] | 0.020 IU/mL |
Secondary
Concentrations for Anti-T and Anti-D.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Concentrations for Anti-T and Anti-D. | Anti-T | 2.694 IU/mL |
| GSK2197870A Group | Concentrations for Anti-T and Anti-D. | Anti-D | 1.767 IU/mL |
| Pediacel Group | Concentrations for Anti-T and Anti-D. | Anti-T | 1.034 IU/mL |
| Pediacel Group | Concentrations for Anti-T and Anti-D. | Anti-D | 1.817 IU/mL |
Secondary
Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-PT [N=107;117] | 107 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-FHA [N=106;119] | 106 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-PRN [N=108;120] | 108 Subjects |
| Pediacel Group | Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-PT [N=107;117] | 117 Subjects |
| Pediacel Group | Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-FHA [N=106;119] | 119 Subjects |
| Pediacel Group | Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-PRN [N=108;120] | 119 Subjects |
Secondary
Number of Seropositive Subjects Against rSBA-MenC.
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
Time frame: At Month 10 and Month 11.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seropositive Subjects Against rSBA-MenC. | rSBA-MenC at Month 10 [N=87;93] | 70 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects Against rSBA-MenC. | rSBA-MenC at Month 11 [N=94;109] | 93 Subjects |
| Pediacel Group | Number of Seropositive Subjects Against rSBA-MenC. | rSBA-MenC at Month 10 [N=87;93] | 78 Subjects |
| Pediacel Group | Number of Seropositive Subjects Against rSBA-MenC. | rSBA-MenC at Month 11 [N=94;109] | 109 Subjects |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.
Time frame: At Month 3
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 9V [N=47;51] | 46 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 18C [N=46;52] | 45 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 6B [N=46;52] | 14 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 19F [N=47;52] | 46 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 14 [N=47;52] | 47 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 23F [N=47;52] | 37 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 4 [N=47;52] | 47 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 23F [N=47;52] | 49 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 4 [N=47;52] | 52 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 6B [N=46;52] | 13 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 9V [N=47;51] | 49 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 14 [N=47;52] | 50 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 18C [N=46;52] | 51 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. | Anti- PNE 19F [N=47;52] | 52 Subjects |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Time frame: At Month 10.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT [N=89;100] | 60 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA [N=89;99] | 89 Subjects |
| GSK2197870A Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN [N=89;100] | 75 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT [N=89;100] | 88 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA [N=89;99] | 98 Subjects |
| Pediacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN [N=89;100] | 72 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
Time frame: At Month 10.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | Anti-polio 1 [N=78;86] | 68 Subjects |
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | Anti-polio 2 [N=78;85] | 63 Subjects |
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | Anti-polio 3 [N=78;86] | 74 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | Anti-polio 1 [N=78;86] | 62 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | Anti-polio 2 [N=78;85] | 69 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3. | Anti-polio 3 [N=78;86] | 76 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-T | 108 Subjects |
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-D | 108 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-T | 119 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-D | 119 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 1 | 89 Subjects |
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 2 | 88 Subjects |
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 3 | 89 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 1 | 93 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 2 | 92 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 3 | 94 Subjects |
Secondary
Number of Seroprotected Subjects for Anti-PRP.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: At Month 10 and Month 11.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-PRP. | Anti-PRP at Month 10 [N=89;98] | 76 Subjects |
| GSK2197870A Group | Number of Seroprotected Subjects for Anti-PRP. | Anti-PRP at Month 11 [N=98;112] | 98 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-PRP. | Anti-PRP at Month 10 [N=89;98] | 81 Subjects |
| Pediacel Group | Number of Seroprotected Subjects for Anti-PRP. | Anti-PRP at Month 11 [N=98;112] | 112 Subjects |
Secondary
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).
Time frame: At Month 10.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | Anti-T ≥ 0.1 IU/mL [N=89;98] | 86 Subjects |
| GSK2197870A Group | Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | Anti-D ≥ 0.1 IU/mL [N=89;98] | 72 Subjects |
| GSK2197870A Group | Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | Anti-D ≥ 0.016 IU/mL [N=16;3] | 11 Subjects |
| Pediacel Group | Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | Anti-T ≥ 0.1 IU/mL [N=89;98] | 87 Subjects |
| Pediacel Group | Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | Anti-D ≥ 0.1 IU/mL [N=89;98] | 94 Subjects |
| Pediacel Group | Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies. | Anti-D ≥ 0.016 IU/mL [N=16;3] | 3 Subjects |
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 or results in disability/incapacity 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 for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2197870A Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | 9 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs). | 6 Subjects |
Secondary
Number of Subjects Reporting Any Solicited General Symptoms.
Solicited general symptoms assessed were drowsiness, irritability, 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)
Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any drowsiness | 103 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any irritability | 122 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any loss of appetite | 79 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any fever | 59 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any fever | 49 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any drowsiness | 103 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any loss of appetite | 77 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any irritability | 117 Subjects |
Secondary
Number of Subjects Reporting Any Solicited General Symptoms.
Solicited general symptoms assessed were drowsiness, irritability, 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)
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any loss of appetite | 41 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any irritability | 75 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any fever | 18 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any drowsiness | 43 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any fever | 20 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any drowsiness | 40 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any irritability | 66 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited General Symptoms. | Any loss of appetite | 40 Subjects |
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)
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any pain | 24 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any redness | 74 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any swelling | 35 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any pain | 11 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any redness | 56 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any swelling | 20 Subjects |
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)
Population: The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any pain | 57 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any redness | 86 Subjects |
| GSK2197870A Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any swelling | 60 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any pain | 57 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any redness | 77 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Solicited Local Symptoms. | Any swelling | 48 Subjects |
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 Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2197870A Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 114 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 112 Subjects |
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 Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2197870A Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 75 Subjects |
| Pediacel Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 66 Subjects |
Secondary
Number of Subjects With a Booster Response to Anti-PRP Antibodies.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
Time frame: At Month 11
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2197870A Group | Number of Subjects With a Booster Response to Anti-PRP Antibodies. | 75 Subjects |
| Pediacel Group | Number of Subjects With a Booster Response to Anti-PRP Antibodies. | 85 Subjects |
Secondary
Number of Subjects With a Booster Response to Anti-PSC Antibodies.
Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.
Time frame: At Month 11
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2197870A Group | Number of Subjects With a Booster Response to Anti-PSC Antibodies. | 48 Subjects |
| Pediacel Group | Number of Subjects With a Booster Response to Anti-PSC Antibodies. | 27 Subjects |
Secondary
Number of Subjects With a Booster Response to rSBA-MenC Antibodies.
Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.
Time frame: At Month 11
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2197870A Group | Number of Subjects With a Booster Response to rSBA-MenC Antibodies. | 68 Subjects |
| Pediacel Group | Number of Subjects With a Booster Response to rSBA-MenC Antibodies. | 61 Subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
Time frame: At Month 2 and Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 2 [N=113;115] | 113 Subjects |
| GSK2197870A Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 3 [N=108;114] | 108 Subjects |
| GSK2197870A Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 2 [N=113;115] | 113 Subjects |
| GSK2197870A Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 3 [N=108;114] | 107 Subjects |
| Pediacel Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 3 [N=108;114] | 114 Subjects |
| Pediacel Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 2 [N=113;115] | 115 Subjects |
| Pediacel Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 2 [N=113;115] | 113 Subjects |
| Pediacel Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 3 [N=108;114] | 114 Subjects |
Secondary
Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.
The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).
Time frame: At Month 3
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2197870A Group | Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off. | 96 Subjects |
| Pediacel Group | Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off. | 98 Subjects |
Secondary
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.
Time frame: At Month 10 and Month 11.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2197870A Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 10 [N=86;97] | 81 Subjects |
| GSK2197870A Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 11 [N=100;111] | 100 Subjects |
| GSK2197870A Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 10 [N=86;97] | 22 Subjects |
| GSK2197870A Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 11 [N=100;111] | 92 Subjects |
| Pediacel Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 11 [N=100;111] | 80 Subjects |
| Pediacel Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 10 [N=86;97] | 89 Subjects |
| Pediacel Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 2.0 µg/mL at Month 10 [N=86;97] | 14 Subjects |
| Pediacel Group | Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs. | Anti-PSC ≥ 0.3 µg/mL at Month 11 [N=100;111] | 111 Subjects |
Secondary
Titers for Anti-polio 1, 2 and 3.
Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.
Time frame: At Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 | 169.4 titers |
| GSK2197870A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 | 90.2 titers |
| GSK2197870A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 | 367.9 titers |
| Pediacel Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 | 89.3 titers |
| Pediacel Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 | 77.7 titers |
| Pediacel Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 | 250.5 titers |
Secondary
Titers for Anti-polio 1, 2 and 3.
Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.
Time frame: At Month 10.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 [N=78;86] | 36.3 titers |
| GSK2197870A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 [N=78;85] | 28.5 titers |
| GSK2197870A Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 [N=78;86] | 70.1 titers |
| Pediacel Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 1 [N=78;86] | 18.8 titers |
| Pediacel Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 2 [N=78;85] | 24.5 titers |
| Pediacel Group | Titers for Anti-polio 1, 2 and 3. | Anti-polio 3 [N=78;86] | 50.7 titers |
Secondary
Titers for rSBA-MenC.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.
Time frame: At Month 2 and Month 3.
Population: The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Titers for rSBA-MenC. | rSBA-MenC at Month 2 [N=109;111] | 339.4 titers |
| GSK2197870A Group | Titers for rSBA-MenC. | rSBA-MenC at Month 3 [N=105;113] | 393.2 titers |
| Pediacel Group | Titers for rSBA-MenC. | rSBA-MenC at Month 2 [N=109;111] | 257.0 titers |
| Pediacel Group | Titers for rSBA-MenC. | rSBA-MenC at Month 3 [N=105;113] | 3110.5 titers |
Secondary
Titers for rSBA-MenC.
Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.
Time frame: At Month 10 and Month 11.
Population: The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2197870A Group | Titers for rSBA-MenC. | rSBA-MenC at Month 10 [N=87;94] | 62.1 titers |
| GSK2197870A Group | Titers for rSBA-MenC. | rSBA-MenC at Month 11 [N=93;109] | 3062.9 titers |
| Pediacel Group | Titers for rSBA-MenC. | rSBA-MenC at Month 10 [N=87;94] | 67.1 titers |
| Pediacel Group | Titers for rSBA-MenC. | rSBA-MenC at Month 11 [N=93;109] | 954.0 titers |