| Primary | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Count of Participants | | Participants | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Demonstration of the non-inferiority of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine compared to Tritanrixâ„¢-HepB/Hiberixâ„¢ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course. | | | | | Difference in anti-PRP SPR rate | -1.18 | | | 2-Sided | 95 | -6.39 | 2.84 | | | | | Non-Inferiority or Equivalence | Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (<) 10%. |
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| Secondary | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | A seroprotected subject is defined as a vaccinated subject with anti-hepatitis B antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Seroprotection was assesed via enzyme-linked immunosorbent assay (ELISA). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off | Seroprotection cut-off values assessed were greater than or equal to (≥) 0.016 international units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination. Concentrations were assessed via neutralization assay on Vero cells. | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen | A seropositive subject was defined as a vaccinated subject with anti-BPT antibody concentration greater than or equal to (≥) 15 ELISA units (EL.U) per milliliter (EL.U/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen | Vaccine response was defined as: for initially seronegative subjects, antibody concentration greater than or equal to (≥) 15 EL.U/mL; and for initially seropositive subjects, antibody concentration ≥ 1 fold the pre-vaccination antibody concentration. | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Number | | Subjects | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). | The analyses were performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable for whom immunogenicity data were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Month 3 | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. | The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Subjects | | During the 4-day (Day 0-3) follow-up period post-vaccination | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade. Grade 3 Irritability= crying that could not be comforted/prevented normal activity. Grade 3 Drowsiness/Loss of appetite= Drowsiness/Loss of appetite that prevented normal activity. Grade 3 fever = fever above (>) 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. | The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Subjects | | During the 4-day (Day 0-3) follow-up period post-vaccination | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 |
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| Secondary | Number of Subjects With Any 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 analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Subjects | | During the 31-day (Day 0-30) follow-up period post-vaccination | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group |
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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 analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Posted | | Number | | Subjects | | During the entire study period (Day 0-Month 3) | | | | ID | Title | Description |
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| OG000 | Tritanrix-HepB/Hiberix Kft. Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG001 | Tritanrix-HepB/Hiberix LD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | | OG002 | Tritanrix-HepB/Hiberix HD Group | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrixâ„¢-HepB/Hiberixâ„¢ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
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