Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Tetanus, Whole Cell Pertussis
Conditions
Keywords
Hepatitis B, Tetanus, Diphtheria, Pertussis, Haemophilus influenzae type b Vaccines
Brief summary
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALZilbrix-Hib
Intramuscular injection, 1 dose
BIOLOGICALTritanrix™-HepB/ Hiberix™
Intramuscular injection, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after a gestation period of 36 to 42 weeks inclusive. * Administration of one dose of hepatitis B vaccine at birth
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period with the exception of OPV. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV). * Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life. * Hepatitis B vaccine received after the first week of life. * Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth). * History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | At Month 3 | A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | At Month 3 | 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). |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | At Month 3 | 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). |
| Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off | At Month 3 | 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. |
| Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | At Month 3 | Seropositivity was defined as antibody concentrations greater than or equal to (≥) 1 microgram/milliliter (µg/mL). |
| Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen | At Month 3 | 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). |
| Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen | At Month 3 | 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. |
| Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen | At Month 3 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). |
| Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | At Month 3 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). |
| Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs) | At Month 3 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0-3) follow-up period post-vaccination | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0-3) follow-up period post-vaccination | 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. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-30) follow-up period post-vaccination | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (Day 0-Month 3) | 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. |
| Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens | At Month 3 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL). |
Countries
India
Participant flow
Pre-assignment details
Out of 300 subjects enrolled in the study, one did not receive any vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Tritanrix-HepB/Hiberix Kft. Group Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | 100 |
| Tritanrix-HepB/Hiberix LD Group Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | 100 |
| Tritanrix-HepB/Hiberix HD Group Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. | 99 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 | 6 |
| Overall Study | Migrated/moved from study area | 3 | 2 | 0 |
| Overall Study | Other | 2 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Tritanrix-HepB/Hiberix Kft. Group | Tritanrix-HepB/Hiberix LD Group | Tritanrix-HepB/Hiberix HD Group | Total |
|---|---|---|---|---|
| Age, Continuous | 6.3 weeks STANDARD_DEVIATION 0.59 | 6.4 weeks STANDARD_DEVIATION 0.64 | 6.3 weeks STANDARD_DEVIATION 0.51 | 6.3 weeks STANDARD_DEVIATION 0.58 |
| Sex: Female, Male Female | 39 Participants | 48 Participants | 37 Participants | 124 Participants |
| Sex: Female, Male Male | 61 Participants | 52 Participants | 62 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 99 |
| other Total, other adverse events | 87 / 100 | 84 / 100 | 81 / 99 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 99 |
Outcome results
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 93 Participants |
| Tritanrix-HepB/Hiberix LD Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 84 Participants |
| Tritanrix-HepB/Hiberix HD Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 89 Participants |
Comparison: Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.95% CI: [-6.39, 2.84]
Comparison: Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.95% CI: [-4.16, 3.99]
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen | 63.4 EL.U/mL |
| Tritanrix-HepB/Hiberix LD Group | Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen | 100.3 EL.U/mL |
| Tritanrix-HepB/Hiberix HD Group | Concentration of Antibodies Against Bordetella Pertussis (BPT) Antigen | 83.7 EL.U/mL |
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 2.894 IU/mL |
| Tritanrix-HepB/Hiberix Kft. Group | Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 4.740 IU/mL |
| Tritanrix-HepB/Hiberix LD Group | Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 1.654 IU/mL |
| Tritanrix-HepB/Hiberix LD Group | Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 2.772 IU/mL |
| Tritanrix-HepB/Hiberix HD Group | Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 1.756 IU/mL |
| Tritanrix-HepB/Hiberix HD Group | Concentration of Antibodies Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 2.825 IU/mL |
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs) | 781.1 mIU/mL |
| Tritanrix-HepB/Hiberix LD Group | Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs) | 695.3 mIU/mL |
| Tritanrix-HepB/Hiberix HD Group | Concentration of Antibodies Against Hepatitis B Surface Antigen (HBs) | 598.2 mIU/mL |
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 26.709 μg/mL |
| Tritanrix-HepB/Hiberix LD Group | Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 19.583 μg/mL |
| Tritanrix-HepB/Hiberix HD Group | Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 40.748 μg/mL |
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen | 92 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen | 85 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Seropositive Subjects Against Bordetella Pertussis (BPT) Antigen | 88 Subjects |
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).
Time frame: At Month 3
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 88 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 80 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Seropositive Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigens | 89 Subjects |
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.
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off | 93 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off | 85 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Seroprotected Subjects Against Diphteria (D) With Antibody Concentrations Above the Cut-off | 89 Subjects |
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | Anti-D | 93 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | Anti-T | 93 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | Anti-D | 85 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | Anti-T | 85 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | Anti-D | 88 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigen | Anti-T | 89 Subjects |
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).
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | 92 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | 85 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | 89 Subjects |
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.
Time frame: During the 4-day (Day 0-3) follow-up period post-vaccination
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 76 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 28 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 55 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 5 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 63 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 16 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 74 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 29 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 54 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 4 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 60 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 20 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 69 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 23 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 53 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 6 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 60 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 16 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 87 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 46 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 73 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 13 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 80 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 32 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 16 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 69 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 61 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 50 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 28 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 53 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 74 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 58 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 15 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 76 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 10 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 6 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 11 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 59 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 50 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 23 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 16 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 45 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 30 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 64 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 5 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 84 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 24 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 39 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 14 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 42 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 4 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 48 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 26 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 15 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 68 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 53 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 10 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 68 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 41 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 30 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 6 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 68 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 17 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 40 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 42 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 10 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 4 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 51 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 11 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 17 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 65 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 81 Subjects |
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.
Time frame: During the 4-day (Day 0-3) follow-up period post-vaccination
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 52 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 2 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 35 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 61 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 49 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 62 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 8 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 49 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 34 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 2 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 31 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 42 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 7 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 46 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 45 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 39 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 57 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 9 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 52 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 36 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 3 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 33 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 45 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 6 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 44 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 42 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 41 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 42 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 7 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 41 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 23 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 2 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 23 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 64 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 10 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 61 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 77 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 73 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 75 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 17 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 72 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 55 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 4 Subjects |
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 52 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 8 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 40 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 49 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 55 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 5 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 46 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 30 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 73 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 3 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 29 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 45 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 35 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 3 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 3 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 35 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 31 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 68 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 2 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 31 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 43 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 45 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 69 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 6 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 37 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 45 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 3 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 31 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 5 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 51 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 27 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 42 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 14 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 47 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 3 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 7 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 38 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 28 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 27 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 3 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 24 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 41 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 58 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 3 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 37 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 66 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 47 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 61 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 1 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 4 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 29 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 28 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 58 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 46 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 41 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 36 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 2 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 3 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 42 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 33 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 38 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 36 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 8 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 19 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 24 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 27 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 57 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 20 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 18 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 33 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 31 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 24 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 26 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 2 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 25 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 24 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 40 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 29 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 26 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 25 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 54 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 29 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 46 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 15 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 33 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 2 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 3 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 4 Subjects |
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.
Time frame: During the 31-day (Day 0-30) follow-up period post-vaccination
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 6 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 4 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 2 Subjects |
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.
Time frame: During the entire study period (Day 0-Month 3)
Population: The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |
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.
Time frame: At Month 3
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tritanrix-HepB/Hiberix Kft. Group | Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen | 91 Subjects |
| Tritanrix-HepB/Hiberix LD Group | Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen | 84 Subjects |
| Tritanrix-HepB/Hiberix HD Group | Number of Subjects With Vaccine Response to Bordetella Pertussis (BPT) Antigen | 88 Subjects |