| Primary | Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. | The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1. | Posted | | Number | | Subjects | | At Year 1 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| | | Title | Denominators | Categories |
|---|
| rSBA-MenC (Pre-Primary) | - ParticipantsOG000204
- ParticipantsOG00160
| |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition. | The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1. | Posted | | Number | | Subjects | | At Year 1 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | rSBA-MenC Antibody Titers | Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1. | Posted | | Geometric Mean | 95% Confidence Interval | Titre | | At Year 1 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. | The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2. | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Meningitec+Hiberix Group | Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region. This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition. | The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition. | The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2. | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Meningitec+Hiberix Group | Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region. This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. |
| |
| Primary | rSBA-MenC Antibody Titers | Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | rSBA-MenC Antibody Titers for Meningitec+Hiberix Group | Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Meningitec+Hiberix Group | Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region. This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition. | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Number | | Subjects | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 | The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition. | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Number | | Subjects | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | rSBA-MenC Antibody Titers | Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL) | The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1. | Posted | | Number | | Subjects | | At Year 1 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PRP Antibodies | Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 1 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group | The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2. | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Meningitec+Hiberix Group | Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region. This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. |
| |
| Primary | Concentration of Anti-PRP Antibodies | Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group | Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Meningitec+Hiberix Group | Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region. This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. |
| |
| Primary | Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL | The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Number | | Subjects | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PRP Antibodies | Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL) | The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1. | Posted | | Number | | Subjects | | At Year 1 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PSC Antibodies | Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 1 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group | The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2. | Posted | | Count of Participants | | Participants | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Meningitec+Hiberix Group | Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region. This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. |
| |
| Primary | Concentration of Anti-PSC Antibodies | Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group | Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Meningitec+Hiberix Group | Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region. This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme. |
| |
| Primary | Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL | The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Number | | Subjects | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PSC Antibodies | Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL) | The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. Persistence of anti-PT, anti-FHA and anti-PRN antibodies were evaluated for the UK subjects of Menitorix group and Meningitec group only | Posted | | Number | | Subjects | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL. | The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. Persistence of anti-PT, anti-FHA and anti-PRN antibodies were evaluated for the UK subjects of Menitorix group and Meningitec group only | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL | The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA). | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Number | | Subjects | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies | Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL. | The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Year 4 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. | The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700. | Posted | | Number | | Subjects | | Up to Month 12 (Booster vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With SAE(s) | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. | The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700. | Posted | | Number | | Subjects | | Up to Month 24 (Booster vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With SAE(s) | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. | The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700. | Posted | | Number | | Subjects | | Up to Month 48 (Booster vaccination) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
| |
| Primary | Number of Subjects With SAE(s) | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. | The Total Cohort Year 2 included all vaccinated subjects in the booster study NCT00258700, who came back for the Year 2 follow-up and also all subjects of Meningitec+Hiberix Group who were enrolled and vaccinated at Visit 2 in study NCT00454987 (i.e. 40-43 months of age). | Posted | | Number | | Subjects | | Within (31-Days) at Year 2 | | | | ID | Title | Description |
|---|
| OG000 | Menitorix Group | Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. | | OG001 | Meningitec Group | Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region. |
|