| Primary | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Number | | subjects | | 18, 30, 42, 54 and 66 months after booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG002 | Infanrix Hexa/Meningitec Group | Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study. |
| | | Title | Denominators | Categories |
|---|
| Month 18 (N= 45; 96; 0) | | | | Month 30 (N= 48; 101; 45) | |
| |
| Primary | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Number | | subjects | | 18, 30, 42, 54 and 66 months after booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
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| Primary | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Number | | subjects | | 18, 30, 42, 54 and 66 months after booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
|
| Primary | rSBA-MenC Titers | Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 18, 30, 42, 54 and 66 months after booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
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| Primary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter). | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Number | | subjects | | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
|
| Primary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter). | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Number | | subjects | | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
|
| Primary | Anti-PRP Concentrations | Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter). | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL (microgram per milliliter) | | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
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| Primary | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Number | | subjects | | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
|
| Primary | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Number | | subjects | | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
|
| Primary | Anti-PSC Concentrations | Concentrations for anti-PSC antibody were expressed as GMCs. | Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050). | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL (microgram per milliliter) | | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
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| Primary | Number of Subjects With Serious Adverse Events | Serious adverse events 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. | Analysis was performed on the Total Cohort, which included all vaccinated subjects in the booster study (NC00323050) and who came back during the follow-up. | Posted | | Number | | subjects | | From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0) | | | | ID | Title | Description |
|---|
| OG000 | Menitorix/Pediarix Group | Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | | OG001 | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. |
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