Haemophilus Influenzae Type b, Neisseria Meningitidis, Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine
Conditions
Keywords
antibody persistence, Meningococcal serogroup C vaccine, conjugate vaccine, Haemophilus influenzae type b vaccine
Brief summary
The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life. This protocol posting deals with objectives & outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The links to objectives and outcome measures of the primary phase & booster phase at 12 to 15 months are provided below: https://www.gsk-studyregister.com/study/2747 (Primary phase) https://www.gsk-studyregister.com/study/2755 (Booster phase)
Detailed description
This multicentre & multicountry study is open and has 2 study groups at Visits 1 and 3 (HibMenC and LicMenC). An additional control group in the UK at the time of the second year follow-up for persistence (subjects aged 40-43 months primed with MenC conjugate and Hib vaccines in infancy with no subsequent booster dose, group NoBoost at Visit 2). These subjects will receive a Hib catch-up vaccine at 40-43 months of age. The subjects of groups HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be further randomized. The subjects of group NoBoost will not be randomized. All subjects at the UK centre will receive Infanrix™-IPV at the second visit (i.e. 24 months after Menitorix booster or at 40-43 months of age). In addition, the subjects of group NoBoost will receive a Hib catch-up vaccine (Menitorix™) at the same visit. Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity analyses: at 12, 24 & 48 months after the booster vaccination. Subjects of group NoBoost will have 1 blood sample taken for immunogenicity analyses at 40-43 months of age. 75 new subjects will be enrolled in this study (group NoBoost).
Interventions
BIOLOGICALMenitorix
Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.
BIOLOGICALInfanrix IPV
Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 64 Months
Healthy volunteers
Yes
Inclusion criteria
Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3. * 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. * Having completed the booster vaccination study 104056. Subjects of group NoBoost at Visit 2 (UK only): * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between and including 40 and 43 months of age at Visit 2. * 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. * Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.
Exclusion criteria
* Previous administration of booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study 104056. * History of H. influenzae type b or meningococcal diseases. * For UK subjects of groups HibMenC and LicMenC only: previous administration of a booster dose of a pertussis-containing vaccine except booster study vaccines during the study 104056.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | At Year 1 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. |
| Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | At Year 1 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition. |
| rSBA-MenC Antibody Titers | At Year 1 | Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation. |
| Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | At Year 2 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. |
| Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group | At Year 2 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. |
| Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group | At Year 2 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition. |
| rSBA-MenC Antibody Titers for Meningitec+Hiberix Group | At Year 2 | Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation. |
| Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | At Year 4 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. |
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | At Year 1 | The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Concentration of Anti-PRP Antibodies | At Year 1 | Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
| Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | At Year 2 | The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group | At Year 2 | The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group | At Year 2 | Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
| Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | At Year 1 | The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Concentration of Anti-PSC Antibodies | At Year 1 | Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
| Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | At Year 2 | The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group | At Year 2 | The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group | At Year 2 | Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
| Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | At Year 2 | The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | At Year 2 | Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL. |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | At Year 4 | The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). |
| Number of Subjects With Serious Adverse Events (SAEs) | Up to Month 12 (Booster vaccination) | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. |
| Number of Subjects With SAE(s) | Up to Month 24 (Booster vaccination) | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. |
Countries
Poland, United Kingdom
Participant flow
Recruitment details
Study participant flow also includes data from the booster phase (NCT00258700), as SAEs were collected on all the subjects enrolled in the booster phase, which included subjects enrolled in the current NCT00454987 study.
Pre-assignment details
Only subjects from booster phase who volunteered to participate in the long term follow up at year 1,2&4 were enrolled at the respective years,leading to higher enrolled subjects at year 2 (386) compared to year 1 (288)
Participants by arm
| Arm | Count |
|---|---|
| Menitorix Group Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | 359 |
| Meningitec Group Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | 117 |
| Meningitec+Hiberix Group Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. | 74 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Booster Period (NCT00258700) | Adverse Event | 1 | 0 | 0 |
| Booster Period (NCT00258700) | Lost to Follow-up | 1 | 0 | 0 |
| Booster Period (NCT00258700) | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Meningitec Group | Total | Menitorix Group | Meningitec+Hiberix Group |
|---|---|---|---|---|
| Age, Continuous | 12.8 Months STANDARD_DEVIATION 0.78 | 12.8 Months STANDARD_DEVIATION 0.76 | 12.8 Months STANDARD_DEVIATION 0.75 | 40.5 Months STANDARD_DEVIATION 0.71 |
| Sex: Female, Male Female | 62 Participants | 241 Participants | 179 Participants | 28 Participants |
| Sex: Female, Male Male | 40 Participants | 135 Participants | 118 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 359 | 0 / 117 | 0 / 74 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 2 / 359 | 0 / 117 | 0 / 74 |
Outcome results
Primary
Concentration of Anti-PRP Antibodies
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 1
Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Primary) | 12.413 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost) | 88.667 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Boost) | 1.293 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP PIV (M12) | 7.153 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Primary) | 0.160 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP PIV (M12) | 3.162 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Primary) | 0.178 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Primary) | 2.473 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Boost) | 0.441 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost) | 39.024 µg/mL |
Primary
Concentration of Anti-PRP Antibodies
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Boost) | 1.276 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M12) | 7.455 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Primary) | 12.715 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M24) | 4.928 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M1) | 90.101 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M48) | 3.824 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Primary) | 0.149 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M48) | 1.673 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Primary) | 0.180 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Primary) | 1.776 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Boost) | 0.380 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M1) | 39.105 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M12) | 3.557 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M24) | 2.083 µg/mL |
Primary
Concentration of Anti-PRP Antibodies
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Primary) | 0.153 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Primary) | 12.794 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Boost) | 1.260 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M1) | 91.981 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M12) | 7.107 µg/mL |
| Menitorix Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M24) | 4.790 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M12) | 3.456 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Primary) | 0.163 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M1) | 44.002 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Primary) | 2.396 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Post-Boost M24) | 2.339 µg/mL |
| Meningitec Group | Concentration of Anti-PRP Antibodies | Anti-PRP (Pre-Boost) | 0.425 µg/mL |
Primary
Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menitorix Group | Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group | 0.668 µg/mL |
Primary
Concentration of Anti-PSC Antibodies
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Boost) | 0.76 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M12]) | 0.48 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Primary) | 9.41 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M24]) | 0.27 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M1]) | 7.46 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M48]) | 0.21 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Primary) | 0.19 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M48]) | 0.17 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Primary) | 0.16 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Primary) | 11.88 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Boost) | 0.85 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M1]) | 3.76 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M12]) | 0.34 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Boost [M24]) | 0.19 µg/mL |
Primary
Concentration of Anti-PSC Antibodies
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 1
Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Primary) | 9.52 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster) | 7.36 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Booster) | 0.77 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (PIV [M12]) | 0.47 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Primary) | 0.18 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (PIV [M12]) | 0.32 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Primary) | 0.17 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Primary) | 11.20 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Booster) | 0.84 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster) | 3.51 µg/mL |
Primary
Concentration of Anti-PSC Antibodies
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Primary) | 0.20 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Primary) | 9.35 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Booster) | 0.74 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster [M1]) | 7.41 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster [M12]) | 0.47 µg/mL |
| Menitorix Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster [M24]) | 0.25 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster [M12]) | 0.32 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Primary) | 0.17 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster [M1]) | 3.91 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Primary) | 12.29 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Post-Booster [M24]) | 0.21 µg/mL |
| Meningitec Group | Concentration of Anti-PSC Antibodies | Anti-PSC (Pre-Booster) | 0.87 µg/mL |
Primary
Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menitorix Group | Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group | 0.16 µg/mL |
Primary
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. Persistence of anti-PT, anti-FHA and anti-PRN antibodies were evaluated for the UK subjects of Menitorix group and Meningitec group only
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M10) | 30.4 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M3) | 44.8 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Boost | 15.1 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Boost | 2.9 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Primary | 4.2 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Primary | 3.2 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M3) | 116.3 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Primary | 6.5 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M10) | 12.5 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M3) | 223.5 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Boost | 5.9 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M10) | 4.9 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Boost | 4.3 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Primary | 3.3 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M3) | 40.1 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M10) | 4.5 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Boost | 3.0 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M3) | 160.2 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M10) | 25.8 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Boost | 20.3 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Primary | 3.1 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M3) | 46.1 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M10) | 6.6 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Primary | 7.8 EL.U/mL |
Primary
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Boost ( M24) | 8.2 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Boost ( M32) | 16.7 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M3) | 45.2 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Boost ( M24) | 164.7 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Primary | 7.2 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Primary | 3.9 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Boost ( M32) | 3.0 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M3) | 135.6 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M3) | 229.9 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M10) | 5.1 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M10) | 12.2 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Boost ( M32) | 6.6 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M10) | 27.2 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Boost ( M24) | 102.8 EL.U/mL |
| Menitorix Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Primary | 3.4 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Boost ( M24) | 23.4 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Primary | 3.4 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M3) | 36.5 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Primary (M10) | 3.9 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Pre-Boost ( M32) | 3.1 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT Post-Boost ( M24) | 7.2 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Primary | 9.1 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M3) | 169.8 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Primary (M10) | 22.8 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Pre-Boost ( M32) | 33.1 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA Post-Boost ( M24) | 66.8 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Primary | 3.1 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M3) | 50.4 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Post-Primary (M10) | 5.6 EL.U/mL |
| Meningitec Group | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN Pre-Boost ( M32) | 4.9 EL.U/mL |
Primary
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. Persistence of anti-PT, anti-FHA and anti-PRN antibodies were evaluated for the UK subjects of Menitorix group and Meningitec group only
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Pre-Primary | 11 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Post-Primary (M3) | 63 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Post-Primary (M10) | 34 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Pre-Boost | 8 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Pre-Primary | 40 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Post-Primary (M3) | 63 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Post-Primary (M10) | 65 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Pre-Boost | 47 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Pre-Primary | 22 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Post-Primary (M3) | 63 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Post-Primary (M10) | 53 Subjects |
| Menitorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Pre-Boost | 34 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Post-Primary (M10) | 14 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Pre-Primary | 3 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Post-Primary (M10) | 21 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Post-Primary (M3) | 20 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Post-Primary (M3) | 20 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Post-Primary (M10) | 10 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Pre-Boost | 13 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PT Pre-Boost | 3 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Pre-Boost | 7 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Pre-Primary | 12 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-PRN Pre-Primary | 4 Subjects |
| Meningitec Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | Anti-FHA Post-Primary (M3) | 20 Subjects |
Primary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 1
Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Post-Primary) | 199 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) | 20 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) | 204 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Post-Boost) | 198 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Post-Primary) | 203 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) | 84 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL PIV (M12) | 203 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) | 198 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL PIV (M12) | 188 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Post-Boost) | 120 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL PIV (M12) | 52 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) | 25 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) | 58 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Post-Primary) | 45 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Post-Primary) | 63 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) | 63 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) | 11 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL (Post-Boost) | 43 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 1.0 µg/mL (Post-Boost) | 19 Subjects |
| Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | Anti-PRP ≥ 0.15 µg/mL PIV (M12) | 63 Subjects |
Primary
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Primary) | 191 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1) | 195 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) | 77 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12) | 164 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) | 191 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12) | 157 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Primary) | 196 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24) | 193 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) | 119 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24) | 174 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M48) | 197 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) | 14 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M48) | 171 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1) | 195 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M48) | 36 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) | 24 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) | 9 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Primary) | 48 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Primary) | 33 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) | 38 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) | 14 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1) | 57 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1) | 57 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12) | 48 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12) | 40 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24) | 55 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M48) | 58 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24) | 40 Subjects |
Primary
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) | 18 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1) | 228 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Primary) | 222 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1) | 228 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) | 93 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12) | 182 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) | 222 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12) | 172 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Primary) | 227 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24) | 227 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) | 134 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24) | 203 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24) | 56 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) | 30 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) | 9 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Primary) | 66 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Primary) | 52 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) | 53 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) | 21 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1) | 75 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1) | 75 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12) | 57 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12) | 48 Subjects |
| Meningitec Group | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24) | 74 Subjects |
Primary
Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group | Anti-PRP ≥ 0.15 µg/mL (Aged 40-43 mths) | 62 Subjects |
| Menitorix Group | Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group | Anti-PRP ≥ 1.0 µg/mL (Aged 40-43 mths) | 28 Subjects |
Primary
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) | 26 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Primary) | 12 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Primary) | 225 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Primary) | 224 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) | 188 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Booster) | 27 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Booster [M1] | 230 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Booster) [M1] | 210 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3µg/mL (Post-Booster [M12] | 110 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Booster [M12]) | 16 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥0.3 µg/mL (Post-Booster [M24] | 76 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Booster [M24]) | 5 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥0.3 µg/mL (Post-Booster [M24] | 17 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) | 6 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Booster [M1] | 76 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Primary) | 1 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Booster [M12]) | 2 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Primary) | 72 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Booster) [M1] | 59 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Primary) | 72 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Booster [M24]) | 0 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) | 66 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3µg/mL (Post-Booster [M12] | 26 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Booster) | 13 Subjects |
Primary
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M1]) | 179 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Primary) | 193 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M12]) | 101 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) | 19 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M12]) | 15 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Boost) | 163 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M24]) | 69 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Primary) | 194 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M24]) | 5 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Boost) | 24 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M48]) | 38 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Primary) | 7 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M48]) | 6 Subjects |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M1]) | 197 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M48]) | 0 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) | 3 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Primary) | 1 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Primary) | 54 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Primary) | 54 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Pre-Boost) | 52 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Pre-Boost) | 9 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M1]) | 43 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M12]) | 22 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M12]) | 2 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M24]) | 10 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 2 µg/mL (Post-Boost [M24]) | 0 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M48]) | 4 Subjects |
| Meningitec Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M1]) | 58 Subjects |
Primary
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group | Anti-PSC ≥ 0.3 µg/mL (Aged 40-43 mths) | 4 Participants |
| Menitorix Group | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group | Anti-PSC ≥2 µg/mL (Aged 40-43 mths) | 0 Participants |
Primary
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Post-Boost ( M24) | 30 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Pre-Boost ( M32) | 29 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Post-Primary (M3) | 42 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Post-Boost ( M24) | 41 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Pre-Primary | 27 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Pre-Primary | 13 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Pre-Boost ( M32) | 6 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Post-Primary (M3) | 42 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Post-Primary (M3) | 42 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Post-Primary (M10) | 36 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Post-Primary (M10) | 24 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Pre-Boost ( M32) | 25 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Post-Primary (M10) | 43 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Post-Boost ( M24) | 43 Subjects |
| Menitorix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Pre-Primary | 9 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Post-Boost ( M24) | 14 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Pre-Primary | 2 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Post-Primary (M3) | 11 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Post-Primary (M10) | 5 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Pre-Boost ( M32) | 2 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PT Post-Boost ( M24) | 9 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Pre-Primary | 9 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Post-Primary (M3) | 11 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Post-Primary (M10) | 13 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Pre-Boost ( M32) | 10 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-FHA Post-Boost ( M24) | 14 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Pre-Primary | 3 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Post-Primary (M3) | 11 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Post-Primary (M10) | 8 Subjects |
| Meningitec Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | Anti-PRN Pre-Boost ( M32) | 4 Subjects |
Primary
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time frame: At Year 1
Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) | 19 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Pre-Primary) | 8 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Post-Primary) | 202 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Post-Primary) | 201 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) | 170 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Pre-Booster) | 27 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Post-Booster) | 205 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Post-Booster) | 183 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (PIV [M12]) | 119 Subjects |
| Menitorix Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (PIV [M12]) | 19 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Post-Booster) | 47 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) | 4 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Pre-Booster) | 10 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Pre-Primary) | 1 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (PIV [M12]) | 2 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Post-Primary) | 63 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Post-Booster) | 64 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 2 µg/mL (Post-Primary) | 63 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (PIV [M12]) | 29 Subjects |
| Meningitec Group | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) | 56 Subjects |
Primary
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Time frame: At Year 1
Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Primary) | 189 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster) | 199 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Booster) | 94 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC PIV (M12) | 109 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Primary) | 3 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC PIV (M12) | 17 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Primary) | 0 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Primary) | 63 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Booster) | 19 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster) | 56 Subjects |
Primary
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M1) | 193 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Primary) | 2 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M12) | 88 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M24) | 78 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Boost) | 87 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M48) | 58 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Primary) | 182 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M48) | 5 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Primary) | 0 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Primary) | 55 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Boost) | 17 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M1) | 50 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M24) | 6 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Boost M12) | 11 Subjects |
Primary
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Primary) | 5 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Primary) | 208 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Booster) | 96 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster M1) | 225 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster M12) | 98 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster M24) | 86 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster M12) | 15 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Primary) | 0 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster M1) | 66 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Primary) | 73 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Post-Booster M24) | 10 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | rSBA-MenC (Pre-Booster) | 22 Subjects |
Primary
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group | 11 Subjects |
Primary
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Pre-Boost) | 156 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M12) | 148 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Primary) | 192 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M24) | 123 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M1) | 194 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M48) | 115 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Pre-Primary) | 10 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M48) | 26 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Pre-Primary) | 2 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Primary) | 55 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Pre-Boost) | 34 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M1) | 56 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M12) | 30 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | rSBA-MenC (Post-Boost M24) | 20 Subjects |
Primary
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Pre-Primary) | 16 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Primary) | 222 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Pre-Booster) | 175 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Booster M1) | 227 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Booster M12) | 164 Subjects |
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Booster M24) | 147 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Booster M12) | 37 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Pre-Primary) | 2 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Booster M1) | 73 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Primary) | 73 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Post-Booster M24) | 30 Subjects |
| Meningitec Group | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | rSBA-MenC (Pre-Booster) | 48 Subjects |
Primary
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group | 30 Subjects |
Primary
Number of Subjects With SAE(s)
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Time frame: Within (31-Days) at Year 2
Population: The Total Cohort Year 2 included all vaccinated subjects in the booster study NCT00258700, who came back for the Year 2 follow-up and also all subjects of Meningitec+Hiberix Group who were enrolled and vaccinated at Visit 2 in study NCT00454987 (i.e. 40-43 months of age).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With SAE(s) | 1 Subjects |
| Meningitec Group | Number of Subjects With SAE(s) | 0 Subjects |
| Meningitec+Hiberix Group | Number of Subjects With SAE(s) | 0 Subjects |
Primary
Number of Subjects With SAE(s)
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Time frame: Up to Month 24 (Booster vaccination)
Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With SAE(s) | 0 Subjects |
| Meningitec Group | Number of Subjects With SAE(s) | 0 Subjects |
Primary
Number of Subjects With SAE(s)
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Time frame: Up to Month 48 (Booster vaccination)
Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With SAE(s) | 1 Subjects |
| Meningitec Group | Number of Subjects With SAE(s) | 0 Subjects |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Time frame: Up to Month 12 (Booster vaccination)
Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
Primary
Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Time frame: At Year 1
Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Post-Primary) | 200 Subjects |
| Menitorix Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Post-Booster) | 201 Subjects |
| Menitorix Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Pre-Booster) | 163 Subjects |
| Menitorix Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC PIV (M12) | 178 Subjects |
| Menitorix Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Pre-Primary) | 12 Subjects |
| Meningitec Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC PIV (M12) | 41 Subjects |
| Meningitec Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Pre-Primary) | 3 Subjects |
| Meningitec Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Post-Primary) | 63 Subjects |
| Meningitec Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Pre-Booster) | 39 Subjects |
| Meningitec Group | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | rSBA-MenC (Post-Booster) | 61 Subjects |
Primary
rSBA-MenC Antibody Titers
Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Primary) | 5.0 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Primary) | 592.3 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Booster) | 58.6 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster M1) | 2320.8 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster M12) | 122.3 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster M24) | 48.0 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster M12) | 35.9 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Primary) | 4.2 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster M1) | 520.9 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Primary) | 1075.6 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster M24) | 14.4 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Booster) | 35.0 Titer |
Primary
rSBA-MenC Antibody Titers
Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: At Year 1
Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Primary) | 624.7 Titre |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster) | 2540.3 Titre |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Booster) | 67.1 Titre |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC PIV (M12) | 123.0 Titre |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Primary) | 4.8 Titre |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC PIV (M12) | 35.7 Titre |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Primary) | 4.3 Titre |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Primary) | 1000.0 Titre |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Booster) | 32.4 Titre |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Booster) | 517.4 Titre |
Primary
rSBA-MenC Antibody Titers
Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: At Year 4
Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Boost) | 64.3 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M12) | 124.1 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Primary) | 616.1 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M24) | 47.9 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M1) | 2537.0 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M48) | 30.4 Titer |
| Menitorix Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Primary) | 4.7 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M48) | 11.3 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Primary) | 4.2 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Primary) | 983.9 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Pre-Boost) | 30.8 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M1) | 507.0 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M12) | 30.6 Titer |
| Meningitec Group | rSBA-MenC Antibody Titers | rSBA-MenC (Post-Boost M24) | 12.1 Titer |
Primary
rSBA-MenC Antibody Titers for Meningitec+Hiberix Group
Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: At Year 2
Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menitorix Group | rSBA-MenC Antibody Titers for Meningitec+Hiberix Group | 15.9 Titer |