Poliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Hepatitis B, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Conditions
Keywords
Infanrix hexa™, Primary vaccination, India, combination vaccine, infants
Brief summary
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
Interventions
BIOLOGICALInfanrix hexa™
Intramuscular, three doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 10 Weeks
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy ALL the following criteria at study entry: * A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination * Documented administration of a hepatitis B vaccine dose at birth * Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol * Written informed consent obtained from the parent(s)/LAR(s) of the subject * Healthy subjects as established by medical history and clinical examination before entering into the study * Born after a gestation period of at least 36 weeks
Exclusion criteria
The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study: * Child in care * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose * Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * Family history of congenital or hereditary immunodeficiency * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine * Major congenital defects or serious chronic illness * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period * Acute disease and/or fever at the time of enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | One month post Dose 3 (Month 3 or Month 5) | 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). |
| Number of Seroprotected Subjects Against Hepatitis B (HBs) | One month post Dose 3 (Month 3 or Month 5) | A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL). |
| Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | One month post Dose 3 (Month 3 or Month 5) | 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). |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens | One month post Dose 3 (Month 3 or Month 5) | A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). |
| Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | One month post Dose 3 (Month 3 or Month 5) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | One month post Dose 3 (Month 3 or Month 5) | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL. |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | At Month 0 | 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). |
| Number of Seroprotected Subjects Against Anti-HBs Antigens | At Month 0 | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. |
| Anti-Polio Types 1, 2 and 3 Antibody Titers | At Month 0 | Antibody titers were presented as geometric mean titers (GMTs). |
| Anti-D and Anti-T Antibody Concentrations | One month post Dose 3 (Month 3 or Month 5) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). |
| Number of Subjects With Solicited General Symptoms | 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) | 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. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | 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) | 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 (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)) | 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. |
| Number of Subjects With Any Solicited Local Symptoms | 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) | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade. |
| Anti-HBs Antibody Concentrations | One month post Dose 3 (Month 3 or Month 5) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). |
| Anti-Polio Types 1, 2, 3 Antibody Titers | One month post Dose 3 (Month 3 or Month 5) | Antibody titers were presented as geometric mean titers (GMTs). |
| Anti-PRP Antibody Concentrations | One month post Dose 3 (Month 3 or Month 5) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | One month post Dose 3 (Month 3 or Month 5) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. |
Countries
India
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| 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. | 112 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Migrated/moved from study area | 1 | 0 |
Baseline characteristics
| Characteristic | Infanrix Hexa 6-10-14 Group | Infanrix Hexa 2-4-6 Group | Total |
|---|---|---|---|
| Age, Continuous | 6.7 Weeks STANDARD_DEVIATION 1.04 | 6.8 Weeks STANDARD_DEVIATION 1.13 | 6.75 Weeks STANDARD_DEVIATION 1.08 |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage | 112 Participants | 112 Participants | 224 Participants |
| Sex: Female, Male Female | 52 Participants | 52 Participants | 104 Participants |
| Sex: Female, Male Male | 60 Participants | 60 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 112 |
| other Total, other adverse events | 45 / 112 | 36 / 112 |
| serious Total, serious adverse events | 2 / 112 | 3 / 112 |
Outcome results
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).
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 105 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 105 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 106 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 106 Participants |
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).
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Hepatitis B (HBs) | 101 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Hepatitis B (HBs) | 104 Participants |
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).
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | Anti-Polio 1 | 99 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | Anti-Polio 2 | 77 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | Anti-Polio 3 | 73 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | Anti-Polio 1 | 99 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | Anti-Polio 2 | 88 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens | Anti-Polio 3 | 79 Participants |
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).
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens | 104 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens | 105 Participants |
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.
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, S- | 61 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, S+ | 44 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, S- | 12 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, S+ | 86 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, S- | 86 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, S+ | 18 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, S- | 89 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, S- | 67 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, S+ | 88 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT, S+ | 36 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN, S+ | 14 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA, S- | 12 Participants |
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).
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 2.334 IU/mL |
| Infanrix Hexa 6-10-14 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 3.307 IU/mL |
| Infanrix Hexa 2-4-6 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 3.726 IU/mL |
| Infanrix Hexa 2-4-6 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 4.904 IU/mL |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-HBs Antibody Concentrations | 1695.7 mIU/mL |
| Infanrix Hexa 2-4-6 Group | Anti-HBs Antibody Concentrations | 3314.5 mIU/mL |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time frame: At Month 0
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-HBs Antibody Concentrations | 5.9 mIU/mL |
| Infanrix Hexa 2-4-6 Group | Anti-HBs Antibody Concentrations | 5.6 mIU/mL |
Secondary
Anti-Polio Types 1, 2, 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-Polio Types 1, 2, 3 Antibody Titers | Anti-Polio 1 | 884.3 Titers |
| Infanrix Hexa 6-10-14 Group | Anti-Polio Types 1, 2, 3 Antibody Titers | Anti-Polio 2 | 840.2 Titers |
| Infanrix Hexa 6-10-14 Group | Anti-Polio Types 1, 2, 3 Antibody Titers | Anti-Polio 3 | 923.7 Titers |
| Infanrix Hexa 2-4-6 Group | Anti-Polio Types 1, 2, 3 Antibody Titers | Anti-Polio 1 | 1799.2 Titers |
| Infanrix Hexa 2-4-6 Group | Anti-Polio Types 1, 2, 3 Antibody Titers | Anti-Polio 2 | 2138.7 Titers |
| Infanrix Hexa 2-4-6 Group | Anti-Polio Types 1, 2, 3 Antibody Titers | Anti-Polio 3 | 2245.5 Titers |
Secondary
Anti-Polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 0
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-Polio Types 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 53.5 Titers |
| Infanrix Hexa 6-10-14 Group | Anti-Polio Types 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 32.5 Titers |
| Infanrix Hexa 6-10-14 Group | Anti-Polio Types 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 8 Titers |
| Infanrix Hexa 2-4-6 Group | Anti-Polio Types 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 31.9 Titers |
| Infanrix Hexa 2-4-6 Group | Anti-Polio Types 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 36.2 Titers |
| Infanrix Hexa 2-4-6 Group | Anti-Polio Types 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 11.9 Titers |
Secondary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-PRP Antibody Concentrations | 2.697 µg/mL |
| Infanrix Hexa 2-4-6 Group | Anti-PRP Antibody Concentrations | 5.404 µg/mL |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 107.3 EL.U/mL |
| Infanrix Hexa 6-10-14 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 293.7 EL.U/mL |
| Infanrix Hexa 6-10-14 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 224.4 EL.U/mL |
| Infanrix Hexa 2-4-6 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 108.2 EL.U/mL |
| Infanrix Hexa 2-4-6 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 369.3 EL.U/mL |
| Infanrix Hexa 2-4-6 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 243.6 EL.U/mL |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: At Month 0
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 5 EL.U/mL |
| Infanrix Hexa 6-10-14 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 18.7 EL.U/mL |
| Infanrix Hexa 6-10-14 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 3.4 EL.U/mL |
| Infanrix Hexa 2-4-6 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 4.6 EL.U/mL |
| Infanrix Hexa 2-4-6 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 20.1 EL.U/mL |
| Infanrix Hexa 2-4-6 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 3.2 EL.U/mL |
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.
Time frame: One month post Dose 3 (Month 3 or Month 5)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 105 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 105 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 105 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 106 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 106 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 106 Participants |
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.
Time frame: At Month 0
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 44 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 89 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 19 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 37 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 90 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 15 Participants |
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.
Time frame: At Month 0
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Anti-HBs Antigens | 14 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Anti-HBs Antigens | 13 Participants |
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).
Time frame: At Month 0
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-Polio 1 | 71 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-Polio 2 | 38 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-Polio 3 | 23 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-Polio 1 | 70 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-Polio 2 | 42 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-Polio 3 | 30 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 1 | 23 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 1 | 3 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 1 | 7 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 2 | 13 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 2 | 0 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 3 | 10 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 3 | 3 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 3 | 2 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Across doses | 28 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Across doses | 6 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Across doses | 8 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 1 | 11 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 3 | 6 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 1 | 1 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Across doses | 15 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 1 | 4 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 3 | 0 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 2 | 3 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Across doses | 9 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 3 | 3 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 2 | 2 Participants |
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 (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Dose 1 | 0 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Dose 3 | 0 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Dose 2 | 0 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Dose 3 | 3 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Dose 1 | 1 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Dose 3 | 1 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Dose 2 | 2 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Dose 3 | 3 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Dose 1 | 8 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Across doses | 0 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Dose 2 | 0 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Across doses | 13 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 10 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Across doses | 2 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 5 Participants |
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 17 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Dose 2 | 7 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Dose 1 | 2 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Dose 1 | 5 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Dose 1 | 3 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Dose 1 | 7 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Dose 2 | 0 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Dose 2 | 5 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Dose 2 | 1 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Across doses | 17 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Dose 3 | 0 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Dose 3 | 3 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Dose 3 | 1 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Temperature/(Axillary), Dose 3 | 6 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness, Across doses | 2 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Irritability/fussiness, Across doses | 10 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite, Across doses | 5 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa 6-10-14 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 40 Participants |
| Infanrix Hexa 2-4-6 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 25 Participants |