Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b
Conditions
Keywords
Primary dose, Reactogenicity, Immunogenicity, Booster dose, Combined vaccine, Russian Infants, Infanrix®-IPV/Hib
Brief summary
The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule
Interventions
BIOLOGICALInfanrix-IPV/Hib
Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 19 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/Legally Acceptable Representatives \[LARs\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female child between 3 and 4 months of age at the time of the first vaccination. * Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born full-term.
Exclusion criteria
* Child in care * Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * Administration of long-acting immune-modifying drugs at any time during the study period * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of hepatitis B and other vaccines given as part of the national immunisation schedule and as part of routine vaccination practice, that are allowed at any time during the study period. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations. * 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 vaccine/product * Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases. * History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases. * 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. * Serious chronic illness. * History of any neurological disorders or seizures. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥38.0°C for rectal route. * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * 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 for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL). |
| Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50. |
| Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL). |
| Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL. |
| Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL. |
| Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs). |
| Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs). |
| Antibody Concentration for Anti-PRP, Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL. |
| Antibody Concentration for Anti-PRP, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL. |
| Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination | At Month 4 (i.e. one month after 3rd dose of primary vaccination) | The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL. |
| Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL. |
| Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) | The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade. |
| Number of Subjects With Any Solicited Local AEs Following Booster Vaccination | During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15) | The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade. |
| Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) | The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C. |
| Number of Subjects With Any Solicited General AEs Following Booster Vaccination | During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15) | The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C. |
| Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination | During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3) | An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade. |
| Number of Subjects With Unsolicited AEs Following Booster Vaccination | During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15) | An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (i.e. from Day 0 until Month 16) | The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade. |
| Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL. |
| Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50. |
| Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL. |
| Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | At Month 16 (i.e. one month after booster vaccination) | A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DTPa-IPV/Hib Group All subjects received three doses of primary vaccination of the study vaccine, DTPa-IPV/Hib, at 3, 4.5 and 6 months of age and a single dose of booster vaccination at 18 months of age. The vaccine was administered intramuscularly into the upper side of the thigh on the right/left side. | 235 |
| Total | 235 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Consent withdrawal | 3 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Migrated/moved from study area | 4 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | DTPa-IPV/Hib Group |
|---|---|
| Age, Continuous | 14.1 Weeks STANDARD_DEVIATION 1.2 |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 235 Participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 235 |
| other Total, other adverse events | 201 / 235 |
| serious Total, serious adverse events | 3 / 235 |
Outcome results
Primary
Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination
A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination | Anti-FHA antibody ≥ 2.046 IU/mL | 175 Participants |
| DTPa-IPV/Hib Group | Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination | Anti-PRN antibody ≥ 2.187 IU/mL | 175 Participants |
| DTPa-IPV/Hib Group | Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination | Anti-PT antibody ≥ 2.693 IU/mL | 174 Participants |
Primary
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination
A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination | Anti-D antibody ≥ 0.1 IU/mL | 176 Participants |
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination | Anti-T antibody ≥ 0.1 IU/mL | 176 Participants |
Primary
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination
A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination | Anti-Polio 1 antibody ≥ 8 ED50 | 151 Participants |
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination | Anti-Polio 2 antibody ≥ 8 ED50 | 151 Participants |
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination | Anti-Polio 3 antibody ≥ 8 ED50 | 150 Participants |
Primary
Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination
A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination | 179 Participants |
Secondary
Antibody Concentration for Anti-PRP, Post Booster Vaccination
The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| DTPa-IPV/Hib Group | Antibody Concentration for Anti-PRP, Post Booster Vaccination | 28.72 µg/mL |
Secondary
Antibody Concentration for Anti-PRP, Post Primary Vaccination
The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| DTPa-IPV/Hib Group | Antibody Concentration for Anti-PRP, Post Primary Vaccination | 2.97 µg/mL |
Secondary
Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination
The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination | anti-D antibody | 12.11 IU/mL |
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination | anti-T antibody | 8.18 IU/mL |
Secondary
Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination
The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination | Anti-D antibody | 3.24 IU/mL |
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination | Anti-T antibody | 3.14 IU/mL |
Secondary
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination
The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | anti-FHA antibody | 268.4 IU/mL |
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | anti-PRN antibody | 563.4 IU/mL |
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | anti-PT antibody | 107.9 IU/mL |
Secondary
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination
The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination | Anti-FHA antibody | 120.2 IU/mL |
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination | Anti-PRN antibody | 166.1 IU/mL |
| DTPa-IPV/Hib Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination | Anti-PT antibody | 65.0 IU/mL |
Secondary
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination
The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination | anti-Polio 1 antibody | 2185.4 Titers |
| DTPa-IPV/Hib Group | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination | anti-Polio 2 antibody | 2944.1 Titers |
| DTPa-IPV/Hib Group | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination | anti-Polio 3 antibody | 3684.6 Titers |
Secondary
Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination
The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).
Time frame: At Month 4 (i.e. one month after 3rd dose of primary vaccination)
Population: The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination | Anti-Polio 1 antibody | 613.9 Titers |
| DTPa-IPV/Hib Group | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination | Anti-Polio 2 antibody | 591.6 Titers |
| DTPa-IPV/Hib Group | Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination | Anti-Polio 3 antibody | 827.4 Titers |
Secondary
Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination
A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | anti-PT antibody | 188 Participants |
| DTPa-IPV/Hib Group | Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | anti-FHA antibody | 188 Participants |
| DTPa-IPV/Hib Group | Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination | anti-PRN antibody | 187 Participants |
Secondary
Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination
A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL.
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination | anti-D antibody | 188 Participants |
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination | anti-T antibody | 188 Participants |
Secondary
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination
A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination | anti-Polio 1 antibody | 176 Participants |
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination | anti-Polio 2 antibody | 169 Participants |
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination | anti-Polio 3 antibody | 167 Participants |
Secondary
Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination
A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL.
Time frame: At Month 16 (i.e. one month after booster vaccination)
Population: The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTPa-IPV/Hib Group | Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination | 188 Participants |
Secondary
Number of Subjects With Any Solicited General AEs Following Booster Vaccination
The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.
Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)
Population: Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Booster Vaccination | Any Drowsiness | 54 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Booster Vaccination | Any Irritability / Fussiness | 88 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Booster Vaccination | Any Loss Of Appetite | 40 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Booster Vaccination | Any Temperature/(Axillary) (°C) | 26 Participants |
Secondary
Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination
The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.
Time frame: During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
Population: TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Drowsiness, Dose 1 | 82 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Irritability / Fussiness, Dose 1 | 100 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Loss Of Appetite, Dose 1 | 33 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Temperature/(Axillary) (°C), Dose 1 | 14 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Drowsiness, Dose 2 | 69 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Irritability / Fussiness, Dose 2 | 104 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Loss Of Appetite, Dose 2 | 34 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Temperature/(Axillary) (°C), Dose 2 | 32 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Drowsiness, Dose 3 | 65 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Irritability / Fussiness, Dose 3 | 106 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Loss Of Appetite, Dose 3 | 43 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination | Any Temperature/(Axillary) (°C), Dose 3 | 28 Participants |
Secondary
Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination
The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
Population: Total vaccinated cohort (TVC) for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Pain, Dose 1 | 58 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Redness, Dose 1 | 83 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Swelling, Dose 1 | 45 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Pain, Dose 2 | 47 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Redness, Dose 2 | 89 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Swelling, Dose 2 | 58 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Pain, Dose 3 | 50 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Redness, Dose 3 | 96 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination | Any Swelling, Dose 3 | 63 Participants |
Secondary
Number of Subjects With Any Solicited Local AEs Following Booster Vaccination
The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)
Population: Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local AEs Following Booster Vaccination | Any Pain | 71 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local AEs Following Booster Vaccination | Any Redness | 101 Participants |
| DTPa-IPV/Hib Group | Number of Subjects With Any Solicited Local AEs Following Booster Vaccination | Any Swelling | 73 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade.
Time frame: During the entire study period (i.e. from Day 0 until Month 16)
Population: TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented, and TVC for analysis of safety of the booster epoch: all subjects with the booster vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTPa-IPV/Hib Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Number of Subjects With Unsolicited AEs Following Booster Vaccination
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.
Time frame: During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)
Population: Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTPa-IPV/Hib Group | Number of Subjects With Unsolicited AEs Following Booster Vaccination | 13 Participants |
Secondary
Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.
Time frame: During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)
Population: TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DTPa-IPV/Hib Group | Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination | 48 Participants |