| Primary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) | Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection. | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | One month after the third vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8 | rSBA-MenC titer greater than or equal to 1:8 is indicative of protection. | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | One month after the third vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values | Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL. | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | Before vaccination (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter | Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL). | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | One month after the third vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128. | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | Before vaccination (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | rSBA-MenC titer cut-off values assessed include 1:32 and 1:128. | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | One month after the third vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL. | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | Before vaccination (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL. | Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | One month after the third dose | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | Before vaccination (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. | Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Number | | subjects | | One month after the third dose | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL). | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Geometric Mean | 95% Confidence Interval | micrograms per milliliter (µg/mL) | | Before vaccination (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL). | Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Geometric Mean | 95% Confidence Interval | micrograms per milliliter (µg/mL) | | One month after the third dose | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL). | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Before vaccination (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL). | Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | One month after the third dose | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | rSBA-MenC titers are given as geometric mean titers (GMTs). | Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Before vaccination (at Day 0) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | rSBA-MenC titers are given as geometric mean titers (GMTs). | Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | One month after the third dose | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling and are presented across doses. | Analysis was performed on the Primary Total Vaccinated Cohort. | Posted | | Number | | subjects | | During the 4-day follow-up period after any primary vaccination dose | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects Reporting Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses. | Analysis was performed on the Primary Total Vaccinated Cohort. | Posted | | Number | | subjects | | During the 4-day follow-up period after any primary vaccination dose | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Analysis was performed on the Primary Total Vaccinated Cohort. | Posted | | Number | | subjects | | Within 31 days after each primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, is 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 Primary Total Vaccinated Cohort. | Posted | | Number | | subjects | | Throughout the entire primary vaccination phase | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) | Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL). | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Number | | subjects | | Prior to (Month 14) and one month after the booster vaccination (Month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) | Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL). | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Number | | subjects | | Prior to (Month 14) and one month after the booster vaccination (Month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128. | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Number | | subjects | | Prior to (Month 14) and one month after the booster vaccination (Month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL. | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Number | | subjects | | Prior to (Month 14) and one month after the booster vaccination (Month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values | Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component. | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Number | | subjects | | Prior to (Month 14) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
|
| Secondary | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL). | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Geometric Mean | 95% Confidence Interval | micrograms per milliliter (µg/mL) | | Prior to (Month 14) and one month after the booster vaccination (Month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component. | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Prior to (Month 14) the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | rSBA-MenC titers are given as geometric mean titers (GMTs). | Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Prior to (Month 14) and one month after the booster vaccination (Month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects Reporting Solicited Symptoms (Local and General) | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite. | Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available. | Posted | | Number | | subjects | | During the 4-day follow-up period following booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available. | Posted | | Number | | subjects | | Within 31 days after the booster vaccination (month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
| |
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, is 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. Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14). Period 2 is defined as the administration of the booster dose until the end of the study (Month 15). | Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available. | Posted | | Number | | subjects | | 31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15) | | | | ID | Title | Description |
|---|
| OG000 | Preterm Group | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. | | OG001 | Full-term Group | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorixâ„¢, Infanrixâ„¢ penta and Prevenarâ„¢ and a booster dose of Menitorixâ„¢, Infanrixâ„¢ IPV and Prevenarâ„¢ at 16-18 months of age. |
|