| Primary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
| | | Title | Denominators | Categories |
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| Anti-D | | | | Anti-T | | |
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| Primary | Number of Seroprotected Subjects Against Hepatitis B (HBs) | A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Primary | Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Primary | Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens | A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Primary | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed and for whom pre-vaccination data was available for the considered assay. | Posted | | Count of Participants | | Participants | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-Polio Types 1, 2, 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | One month post Dose 3 (Month 3 or Month 5) | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | At Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | At Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Seroprotected Subjects Against Anti-HBs Antigens | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Count of Participants | | Participants | | At Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-Polio Types 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 0 | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group) | | | | ID | Title | Description |
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| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available. | Posted | | Count of Participants | | Participants | | During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)) | | | | ID | Title | Description |
|---|
| OG000 | Infanrix Hexa 6-10-14 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. | | OG001 | Infanrix Hexa 2-4-6 Group | Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexaâ„¢ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. |
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