Neisseria Meningitidis, Haemophilus Influenzae Type b
Conditions
Keywords
Conjugate vaccines, Meningococcal serogroup C vaccine, Antibody persistence, Pneumococcal vaccine, Haemophilus Influenzae type b vaccine
Brief summary
This protocol posting deals with objectives & outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437). The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.
Detailed description
This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 107005 and will not be further randomized in this study.
Interventions
BIOLOGICALMenitorixTM
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
BIOLOGICALPrevenarTM
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
BIOLOGICALMeningitecTM
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
BIOLOGICALNeisVac-CTM
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
BIOLOGICALInfanrixTM hexa
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
BIOLOGICALInfanrixTM penta
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
BIOLOGICALInfanrixTM IPV/Hib
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
BIOLOGICALInfanrixTM IPV
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
36 Months to 76 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 36 and 40 months of age at the time of Visit 1; between, and including, 48 and 52 months of age at the time of Visit 2; and between, and including, 72 and 76 months of age at the time of 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. * Subjects who previously participated in the primary and booster studies, who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part, in the booster study, of the blood sampling subset.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Administration of any additional meningococcal serogroup C, Hib, hepatitis B and pneumococcal vaccine since the end of the booster study * History of meningococcal serogroup C, Haemophilus influenzae type b, hepatitis B and invasive pneumococcal diseases since the end of booster study. * Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of booster study, based on medical history and physical examination (no laboratory testing required). * Administration of immunoglobulins and/or any blood products within the three months preceding the first blood sampling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | At 3 years of age | rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rSBA-MenC Titers | At 3 years of age | Titers are given as Geometric Mean Titers (GMTs). |
| Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | At 3 years of age | The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL. |
| Anti-PRP Concentrations | At 3 years of age | Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL, |
| Antibody Concentrations Against Vaccine Pneumococcal Serotypes | At 3 years of age | Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
| Number of Subjects With Opsonophagocytic Activity | At 3 years of age | Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8. |
| Concentration of Antibodies Against Protein D | At 3 years of age | Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL). |
| Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | At 3 years of age | The cut-off value was defined as a titer equal to or above 1:128. |
| Anti-HBs Antibody Concentrations | At 3 years of age | Concentrations were expressed as GMCs in mIU/mL. |
| Number of Subjects With Serious Adverse Events (SAEs) | From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures. |
| Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value | At 6 years of age | rSBA-MenC antibody cut-off value assessed was equal to or above 1:128. |
| Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | At 3 and 4 years of age | Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL. |
| Anti-HBs Antibody Concentrations as Measured by ELISA | At 3 and 4 years of age | Concentrations were expressed as GMCs in mIU/mL. |
| Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | At 3 years of age | Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL. |
Countries
Germany, Poland, Spain
Participant flow
Pre-assignment details
At 3 years of age, 582 subjects were enrolled. One subject who did not participate in the primary study was enrolled by mistake and was therefore withdrawn from the study. Therefore the total number of subjects participating at the 36 months of age time point was 581.
Participants by arm
| Arm | Count |
|---|---|
| Synflorix-Meningitec Group Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. | 144 |
| Synflorix-NeisVac-C Group Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa. | 147 |
| Synflorix-Menitorix Group Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. | 149 |
| Prevenar-Menitorix Group Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta. | 141 |
| Total | 581 |
Baseline characteristics
| Characteristic | Synflorix-Meningitec Group | Synflorix-NeisVac-C Group | Synflorix-Menitorix Group | Prevenar-Menitorix Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.1 Months STANDARD_DEVIATION 1.17 | 37.2 Months STANDARD_DEVIATION 1.2 | 37.3 Months STANDARD_DEVIATION 1.18 | 37.3 Months STANDARD_DEVIATION 1.28 | 37.2 Months STANDARD_DEVIATION 1.21 |
| Sex: Female, Male Female | 71 Participants | 65 Participants | 86 Participants | 71 Participants | 293 Participants |
| Sex: Female, Male Male | 73 Participants | 82 Participants | 63 Participants | 70 Participants | 288 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 144 | 0 / 147 | 0 / 149 | 0 / 141 |
Outcome results
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 120 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 144 subjects |
| Synflorix-Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 127 subjects |
| Prevenar-Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 113 subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 97 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 132 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 108 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 98 Subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Time frame: At 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 31 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 55 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 50 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value | 34 Subjects |
Secondary
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N= 141; 146; 143; 139) | 0.60 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N= 141; 146; 144; 140) | 0.60 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N= 139; 146; 144; 138) | 0.59 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N= 140; 146; 144; 140) | 0.73 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N= 141; 146; 144; 140) | 0.58 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N= 141; 146; 144; 139) | 2.06 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N= 139; 146; 142; 139) | 0.26 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N= 141; 146; 144; 140) | 1.33 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N= 141; 146; 144; 139) | 0.27 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N= 140; 145; 144; 140) | 0.46 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N= 141; 146; 143; 139) | 0.84 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N= 139; 146; 142; 139) | 0.23 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N= 141; 146; 144; 139) | 1.63 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N= 139; 146; 144; 138) | 0.56 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N= 141; 146; 144; 140) | 0.54 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N= 141; 146; 144; 140) | 0.51 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N= 140; 145; 144; 140) | 0.39 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N= 140; 146; 144; 140) | 0.69 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N= 141; 146; 144; 139) | 0.23 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N= 141; 146; 144; 140) | 1.09 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N= 140; 145; 144; 140) | 0.41 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N= 141; 146; 144; 139) | 1.35 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N= 140; 146; 144; 140) | 0.62 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N= 139; 146; 142; 139) | 0.21 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N= 141; 146; 144; 139) | 0.23 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N= 141; 146; 143; 139) | 0.59 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N= 139; 146; 144; 138) | 0.63 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N= 141; 146; 144; 140) | 0.54 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N= 141; 146; 144; 140) | 0.47 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N= 141; 146; 144; 140) | 1.00 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N= 140; 145; 144; 140) | 0.09 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N= 141; 146; 144; 139) | 0.35 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N= 141; 146; 144; 139) | 1.48 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N= 141; 146; 144; 140) | 0.70 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N= 139; 146; 142; 139) | 0.07 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N= 140; 146; 144; 140) | 1.36 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N= 141; 146; 143; 139) | 0.59 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N= 139; 146; 144; 138) | 0.95 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N= 141; 146; 144; 140) | 1.48 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N= 141; 146; 144; 140) | 0.07 μg/mL |
Secondary
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=136;138;133;136) | 0.98 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=136;138;133;135) | 0.74 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=136;138;131;136) | 0.51 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=136;138;131;135) | 0.22 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=136;138;131;136) | 0.47 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=136;137;131;136) | 0.52 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=136;138;132;136) | 1.51 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=136;138;133;136) | 2.66 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=136;138;132;136) | 0.49 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=136;138;131;136) | 0.22 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=136;137;131;136) | 0.61 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=136;138;131;136) | 0.36 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=136;138;133;135) | 0.65 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=136;138;133;136) | 0.84 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=136;138;133;136) | 2.36 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=136;138;131;135) | 0.21 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=136;138;131;136) | 0.44 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=136;138;131;136) | 0.21 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=136;138;132;136) | 1.57 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=136;138;132;136) | 0.81 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=136;138;132;136) | 1.41 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=136;138;133;136) | 2.50 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=136;138;131;136) | 0.34 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=136;138;133;136) | 0.98 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=136;137;131;136) | 0.54 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=136;138;132;136) | 0.60 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=136;138;131;136) | 0.20 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=136;138;133;135) | 0.78 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=136;138;131;135) | 0.18 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=136;138;131;136) | 0.46 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=136;138;133;136) | 1.56 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=136;138;131;135) | 0.08 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=136;138;131;136) | 0.32 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=136;137;131;136) | 0.72 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=136;138;132;136) | 1.71 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=136;138;131;136) | 0.10 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=136;138;133;135) | 0.99 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=136;138;131;136) | 0.09 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=136;138;132;136) | 0.49 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=136;138;133;136) | 2.41 μg/mL |
Secondary
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=128;136;130;134) | 0.19 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=128;137;130;133) | 2.84 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=128;137;130;132) | 0.52 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=128;136;130;133) | 1.71 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=128;137;130;133) | 3.91 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=128;135;131;131) | 1.71 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=128;135;130;134) | 0.14 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=127;137;130;132) | 0.61 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=128;135;130;131) | 0.37 μg/mL |
| Synflorix-Meningitec Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=128;137;131;132) | 0.76 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=127;137;130;132) | 0.59 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=128;137;130;133) | 3.94 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=128;135;131;131) | 1.13 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=128;137;130;133) | 2.22 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=128;136;130;134) | 0.22 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=128;137;130;132) | 0.75 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=128;135;130;134) | 0.14 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=128;135;130;131) | 0.31 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=128;136;130;133) | 1.70 μg/mL |
| Synflorix-NeisVac-C Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=128;137;131;132) | 0.67 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=128;137;131;132) | 0.57 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=128;136;130;134) | 0.20 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=128;135;130;134) | 0.12 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=128;135;130;131) | 0.30 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=128;135;131;131) | 1.28 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=127;137;130;132) | 0.64 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=128;137;130;133) | 2.81 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=128;137;130;132) | 0.56 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=128;137;130;133) | 4.24 μg/mL |
| Synflorix-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=128;136;130;133) | 1.41 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-9V (N=128;137;131;132) | 0.65 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-23F (N=128;136;130;133) | 2.99 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-7F (N=127;137;130;132) | 0.24 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-6B (N=128;135;131;131) | 1.73 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-5 (N=128;135;130;131) | 0.13 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-19F (N=128;137;130;133) | 3.11 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-4 (N=128;135;130;134) | 0.24 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-14 (N=128;137;130;133) | 2.59 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-1 (N=128;136;130;134) | 0.11 μg/mL |
| Prevenar-Menitorix Group | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | Anti-18C (N=128;137;130;132) | 0.49 μg/mL |
Secondary
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by ELISA. The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA).
Time frame: At 3, 4 and 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Meningitec Group | Anti-HBs Antibody Concentrations | anti-HBs; 6 years (N=122, 129, 125, 128) | 66.7 mIU/mL |
| Synflorix-Meningitec Group | Anti-HBs Antibody Concentrations | anti-HBs; 4 years (N=120, 127, 118, 119) | 130.8 mIU/mL |
| Synflorix-Meningitec Group | Anti-HBs Antibody Concentrations | anti-HBs; 3 years (N= 118, 130, 122, 119) | 211.1 mIU/mL |
| Synflorix-NeisVac-C Group | Anti-HBs Antibody Concentrations | anti-HBs; 6 years (N=122, 129, 125, 128) | 64.7 mIU/mL |
| Synflorix-NeisVac-C Group | Anti-HBs Antibody Concentrations | anti-HBs; 3 years (N= 118, 130, 122, 119) | 189.2 mIU/mL |
| Synflorix-NeisVac-C Group | Anti-HBs Antibody Concentrations | anti-HBs; 4 years (N=120, 127, 118, 119) | 128.4 mIU/mL |
| Synflorix-Menitorix Group | Anti-HBs Antibody Concentrations | anti-HBs; 3 years (N= 118, 130, 122, 119) | 154.5 mIU/mL |
| Synflorix-Menitorix Group | Anti-HBs Antibody Concentrations | anti-HBs; 6 years (N=122, 129, 125, 128) | 45.7 mIU/mL |
| Synflorix-Menitorix Group | Anti-HBs Antibody Concentrations | anti-HBs; 4 years (N=120, 127, 118, 119) | 92.3 mIU/mL |
| Prevenar-Menitorix Group | Anti-HBs Antibody Concentrations | anti-HBs; 4 years (N=120, 127, 118, 119) | 142.5 mIU/mL |
| Prevenar-Menitorix Group | Anti-HBs Antibody Concentrations | anti-HBs; 6 years (N=122, 129, 125, 128) | 85.4 mIU/mL |
| Prevenar-Menitorix Group | Anti-HBs Antibody Concentrations | anti-HBs; 3 years (N= 118, 130, 122, 119) | 218.9 mIU/mL |
Secondary
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL.
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Anti-HBs Antibody Concentrations | 273.5 mIU/mL |
| Synflorix-NeisVac-C Group | Anti-HBs Antibody Concentrations | 238.8 mIU/mL |
| Synflorix-Menitorix Group | Anti-HBs Antibody Concentrations | 174.6 mIU/mL |
| Prevenar-Menitorix Group | Anti-HBs Antibody Concentrations | 284.7 mIU/mL |
Secondary
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL.
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Anti-HBs Antibody Concentrations | 367.5 mIU/mL |
| Synflorix-NeisVac-C Group | Anti-HBs Antibody Concentrations | 325.7 mIU/mL |
| Synflorix-Menitorix Group | Anti-HBs Antibody Concentrations | 288.1 mIU/mL |
| Prevenar-Menitorix Group | Anti-HBs Antibody Concentrations | 371.4 mIU/mL |
Secondary
Anti-HBs Antibody Concentrations as Measured by ELISA
Concentrations were expressed as GMCs in mIU/mL.
Time frame: At 3 and 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix-Meningitec Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 3 years (N= 94, 98, 94, 90) | 433.8 mIU/mL |
| Synflorix-Meningitec Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 4 years (N= 87, 94, 91, 91) | 270.5 mIU/mL |
| Synflorix-NeisVac-C Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 4 years (N= 87, 94, 91, 91) | 263.1 mIU/mL |
| Synflorix-NeisVac-C Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 3 years (N= 94, 98, 94, 90) | 332.3 mIU/mL |
| Synflorix-Menitorix Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 3 years (N= 94, 98, 94, 90) | 302.7 mIU/mL |
| Synflorix-Menitorix Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 4 years (N= 87, 94, 91, 91) | 172.7 mIU/mL |
| Prevenar-Menitorix Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 3 years (N= 94, 98, 94, 90) | 396.5 mIU/mL |
| Prevenar-Menitorix Group | Anti-HBs Antibody Concentrations as Measured by ELISA | anti-HBs; 4 years (N= 87, 94, 91, 91) | 280.2 mIU/mL |
Secondary
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL
Time frame: At 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Anti-PRP Concentrations | 1.655 μg/mL |
| Synflorix-NeisVac-C Group | Anti-PRP Concentrations | 1.647 μg/mL |
| Synflorix-Menitorix Group | Anti-PRP Concentrations | 2.947 μg/mL |
| Prevenar-Menitorix Group | Anti-PRP Concentrations | 2.558 μg/mL |
Secondary
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Anti-PRP Concentrations | 2.293 μg/mL |
| Synflorix-NeisVac-C Group | Anti-PRP Concentrations | 2.222 μg/mL |
| Synflorix-Menitorix Group | Anti-PRP Concentrations | 4.177 μg/mL |
| Prevenar-Menitorix Group | Anti-PRP Concentrations | 3.636 μg/mL |
Secondary
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Anti-PRP Concentrations | 1.767 μg/mL |
| Synflorix-NeisVac-C Group | Anti-PRP Concentrations | 1.738 μg/mL |
| Synflorix-Menitorix Group | Anti-PRP Concentrations | 3.804 μg/mL |
| Prevenar-Menitorix Group | Anti-PRP Concentrations | 2.805 μg/mL |
Secondary
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Concentration of Antibodies Against Protein D | 284.7 EL.U/mL |
| Synflorix-NeisVac-C Group | Concentration of Antibodies Against Protein D | 278.0 EL.U/mL |
| Synflorix-Menitorix Group | Concentration of Antibodies Against Protein D | 266.1 EL.U/mL |
| Prevenar-Menitorix Group | Concentration of Antibodies Against Protein D | 105.2 EL.U/mL |
Secondary
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Concentration of Antibodies Against Protein D | 494.6 EL.U/mL |
| Synflorix-NeisVac-C Group | Concentration of Antibodies Against Protein D | 444.8 EL.U/mL |
| Synflorix-Menitorix Group | Concentration of Antibodies Against Protein D | 439.8 EL.U/mL |
| Prevenar-Menitorix Group | Concentration of Antibodies Against Protein D | 100.3 EL.U/mL |
Secondary
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | Concentration of Antibodies Against Protein D | 401.1 EL.U/mL |
| Synflorix-NeisVac-C Group | Concentration of Antibodies Against Protein D | 387.2 EL.U/mL |
| Synflorix-Menitorix Group | Concentration of Antibodies Against Protein D | 334.8 EL.U/mL |
| Prevenar-Menitorix Group | Concentration of Antibodies Against Protein D | 107.9 EL.U/mL |
Secondary
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 49 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 79 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 75 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 58 Subjects |
Secondary
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
The cut-off value was defined as a titer equal to or above 1:128.
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 69 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 109 subjects |
| Synflorix-Menitorix Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 98 subjects |
| Prevenar-Menitorix Group | Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value | 68 subjects |
Secondary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 105 subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 77 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 81 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 96 subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 102 subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 74 subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 99 subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 74 subjects |
Secondary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values assessed were defined as equal to or above (≥) 6.2 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by Enzyme-Linked Immunosorbent Assay (ELISA). The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA). Anti-HBs seroprotection was redefined as CLIA concentration above 10 mIU/mL.
Time frame: At 3, 4 and 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 6 years (N=122, 129, 125, 128) | 102 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 3 years (N=118,130, 122, 119) | 80 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 3 years (N=118,130, 122, 119) | 110 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 4 years (N= 120, 127, 118, 119) | 110 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 3 years (N=118,130, 122, 119) | 109 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 4 years (N= 120, 127, 118, 119) | 104 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 6 years (N=122, 129, 125, 128) | 100 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 4 years (N= 120, 127, 118, 119) | 70 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 6 years (N=122, 129, 125, 128) | 57 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 3 years (N=118,130, 122, 119) | 121 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 4 years (N= 120, 127, 118, 119) | 76 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 4 years (N= 120, 127, 118, 119) | 113 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 3 years (N=118,130, 122, 119) | 118 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 4 years (N= 120, 127, 118, 119) | 112 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 6 years (N=122, 129, 125, 128) | 103 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 6 years (N=122, 129, 125, 128) | 108 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 3 years (N=118,130, 122, 119) | 84 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 6 years (N=122, 129, 125, 128) | 62 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 4 years (N= 120, 127, 118, 119) | 60 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 4 years (N= 120, 127, 118, 119) | 100 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 6 years (N=122, 129, 125, 128) | 45 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 6 years (N=122, 129, 125, 128) | 91 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 3 years (N=118,130, 122, 119) | 75 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 3 years (N=118,130, 122, 119) | 110 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 3 years (N=118,130, 122, 119) | 108 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 4 years (N= 120, 127, 118, 119) | 104 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 6 years (N=122, 129, 125, 128) | 98 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 4 years (N= 120, 127, 118, 119) | 109 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 3 years (N=118,130, 122, 119) | 111 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 4 years (N= 120, 127, 118, 119) | 73 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 4 years (N= 120, 127, 118, 119) | 107 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 6 years (N=122, 129, 125, 128) | 112 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 6.2 mIU/mL; 3 years (N=118,130, 122, 119) | 113 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 3 years (N=118,130, 122, 119) | 74 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL; 6 years (N=122, 129, 125, 128) | 66 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL; 6 years (N=122, 129, 125, 128) | 108 Subjects |
Secondary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 67 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 86 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 72 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 93 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 86 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 62 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 10 mIU/mL | 90 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 100 mIU/mL | 72 Subjects |
Secondary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA.
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Time frame: At 3 and 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 4 years (N= 87, 94, 91, 91) | 61 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 4 years (N= 87, 94, 91, 91) | 78 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 3 years (N= 94, 98, 94, 90) | 71 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 3 years (N= 94, 98, 94, 90) | 92 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 4 years (N= 87, 94, 91, 91) | 86 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 3 years (N= 94, 98, 94, 90) | 92 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 4 years (N= 87, 94, 91, 91) | 69 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 3 years (N= 94, 98, 94, 90) | 79 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 3 years (N= 94, 98, 94, 90) | 91 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 4 years (N= 87, 94, 91, 91) | 79 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 4 years (N= 87, 94, 91, 91) | 57 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 3 years (N= 94, 98, 94, 90) | 67 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 3 years (N= 94, 98, 94, 90) | 87 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 3 years (N= 94, 98, 94, 90) | 67 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 10 mIU/mL; 4 years (N= 87, 94, 91, 91) | 83 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA. | ≥ 100mIU/mL; 4 years (N= 87, 94, 91, 91) | 67 Subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 133 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 88 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 85 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 134 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 130 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 117 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 132 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 106 Subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 132 subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 101 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 105 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 139 subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 137 subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 127 subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 138 subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 115 subjects |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.
Time frame: At 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 126 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 85 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 77 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 132 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 130 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 110 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 0.15 µg/mL | 132 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values | ≥ 1.0 µg/mL | 100 Subjects |
Secondary
Number of Subjects With Opsonophagocytic Activity
Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (n=131;134;123;128) | 33 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N=113;118;113;118) | 34 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N=128;129;122;126) | 93 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N=127;132;118;126) | 49 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N=126;128;114;121) | 96 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N=129133;119;121) | 98 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N=131;134;123;128) | 131 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N=131;133;123;128) | 87 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N=129;132;122;128) | 65 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N=130;132;120;126) | 125 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N=113;118;113;118) | 56 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (n=131;134;123;128) | 32 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N=127;132;118;126) | 50 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N=129;132;122;128) | 46 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N=128;129;122;126) | 97 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N=126;128;114;121) | 105 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N=131;133;123;128) | 88 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N=131;134;123;128) | 134 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N=130;132;120;126) | 130 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N=129133;119;121) | 108 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N=129;132;122;128) | 40 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N=113;118;113;118) | 46 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (n=131;134;123;128) | 20 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N=131;133;123;128) | 80 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N=127;132;118;126) | 36 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N=131;134;123;128) | 123 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N=129133;119;121) | 86 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N=130;132;120;126) | 118 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N=128;129;122;126) | 101 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N=126;128;114;121) | 95 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N=126;128;114;121) | 110 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N=131;134;123;128) | 126 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N=113;118;113;118) | 45 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N=127;132;118;126) | 72 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (n=131;134;123;128) | 12 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N=130;132;120;126) | 122 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N=131;133;123;128) | 89 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N=128;129;122;126) | 111 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N=129;132;122;128) | 5 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N=129133;119;121) | 111 Subjects |
Secondary
Number of Subjects With Opsonophagocytic Activity
Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8.
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (N= 131; 131; 131; 131) | 30 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N= 128; 127; 124; 131) | 84 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N= 126; 127; 129; 128) | 54 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N= 131; 131; 129; 132) | 127 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N= 131; 130; 131; 130) | 128 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N= 125; 124; 125; 132) | 106 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N= 126; 121; 123; 122) | 51 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N= 130; 130; 129; 132) | 73 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N= 130; 130; 131; 132) | 105 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N= 129; 128; 128; 131) | 110 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N= 131; 131; 129; 132) | 131 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (N= 131; 131; 131; 131) | 32 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N= 126; 127; 129; 128) | 48 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N= 130; 130; 129; 132) | 47 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N= 128; 127; 124; 131) | 81 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N= 131; 130; 131; 130) | 130 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N= 129; 128; 128; 131) | 118 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N= 126; 121; 123; 122) | 68 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N= 125; 124; 125; 132) | 112 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N= 130; 130; 131; 132) | 108 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N= 128; 127; 124; 131) | 78 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N= 131; 131; 129; 132) | 127 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N= 130; 130; 129; 132) | 55 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N= 129; 128; 128; 131) | 106 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N= 126; 127; 129; 128) | 43 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (N= 131; 131; 131; 131) | 29 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N= 126; 121; 123; 122) | 44 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N= 125; 124; 125; 132) | 113 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N= 130; 130; 131; 132) | 89 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N= 131; 130; 131; 130) | 131 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-5 (N= 130; 130; 129; 132) | 5 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-4 (N= 126; 127; 129; 128) | 77 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-9V (N= 131; 131; 129; 132) | 124 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-18C (N= 126; 121; 123; 122) | 48 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-19F (N= 130; 130; 131; 132) | 91 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-1 (N= 131; 131; 131; 131) | 14 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-14 (N= 129; 128; 128; 131) | 112 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-23F (N= 125; 124; 125; 132) | 129 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-6B (N= 128; 127; 124; 131) | 115 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Opsonophagocytic Activity | Opsono-7F (N= 131; 130; 131; 130) | 126 Subjects |
Secondary
Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.
Time frame: At 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value | 11 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value | 19 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value | 15 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value | 14 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age
Population: Analysis was performed on the Total Enrolled cohort at 6 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age
Population: Analysis was performed on the Total Enrolled cohort at 3 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 subjects |
| Synflorix-Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 subjects |
| Synflorix-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 subjects |
| Synflorix-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 subjects |
| Prevenar-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 subjects |
| Prevenar-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age
Population: Analysis was performed on the Total Enrolled cohort at 4 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Synflorix-Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
| Synflorix-Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Synflorix-NeisVac-C Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
| Synflorix-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAE(s) | 0 Subjects |
| Prevenar-Menitorix Group | Number of Subjects With Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
Secondary
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Time frame: At 6 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | rSBA-MenC Titers | 7.2 Titer |
| Synflorix-NeisVac-C Group | rSBA-MenC Titers | 11.9 Titer |
| Synflorix-Menitorix Group | rSBA-MenC Titers | 10.1 Titer |
| Prevenar-Menitorix Group | rSBA-MenC Titers | 8.5 Titer |
Secondary
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Time frame: At 4 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | rSBA-MenC Titers | 45.3 Titers |
| Synflorix-NeisVac-C Group | rSBA-MenC Titers | 146.8 Titers |
| Synflorix-Menitorix Group | rSBA-MenC Titers | 112.4 Titers |
| Prevenar-Menitorix Group | rSBA-MenC Titers | 68.1 Titers |
Secondary
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Time frame: At 3 years of age
Population: Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Synflorix-Meningitec Group | rSBA-MenC Titers | 100.5 Titer |
| Synflorix-NeisVac-C Group | rSBA-MenC Titers | 235.3 Titer |
| Synflorix-Menitorix Group | rSBA-MenC Titers | 167.5 Titer |
| Prevenar-Menitorix Group | rSBA-MenC Titers | 84.0 Titer |