Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b, Tetanus
Conditions
Keywords
combination vaccine, booster vaccination
Brief summary
The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).
Interventions
BIOLOGICALInfanrix+Hib™
Intramuscular, one dose
BIOLOGICALPoliorix™
Intramuscular, one dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination. * Subjects who completed the full three-dose primary vaccination course in study NCT01086423. * 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.
Exclusion criteria
* Child in care * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period. * Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423. * Serious chronic illness. * Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period. * Occurrence of any of the following adverse events after a previous administration of a DTP vaccine. * Encephalopathy * Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause. * Collapse or shock-like state within 48 hours of vaccination. * Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours. * Seizures with or without fever occurring within 3 days of vaccination. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | One month after the booster vaccination (At Month 1) | Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies. |
| Number of Seroprotected Subjects Against PRP | One month after the booster vaccination (At Month 1) | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. |
| Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Before the booster vaccination (At Day 0) | A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Before the booster vaccination (At Day 0) | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL). |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | One month after the booster vaccination (At Month 1) | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Before the booster vaccination (At Day 0) | A seroprotected subject was 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). |
| Anti-D and Anti-T Antibody Concentrations | Before the booster vaccination (At Day 0) | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL. |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) | Before the booster vaccination (At Day 0) | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). |
| Anti-PRP Antibody Concentrations | Before the booster vaccination (At Day 0) | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Before the booster vaccination (At Day 0) | A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. |
| Anti-polio Type 1, 2 and 3 Antibody Titers | Before the booster vaccination (At Day 0) | Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8. |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Before the booster vaccination (At Day 0) | A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml). |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Before the booster vaccination (At Day 0) | Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Before the booster vaccination (At Day 0) | A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL. |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Before the booster vaccination (At Day 0) | A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period | 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 1) | 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 | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
Countries
China
Participant flow
Recruitment details
6 subjects did not receive vaccination.
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+Hib/Poliorix 1 Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | 272 |
| Infanrix+Hib/Poliorix 2 Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | 273 |
| Control Group Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | 280 |
| Total | 825 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Migrated/moved from study area | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Infanrix+Hib/Poliorix 1 Group | Infanrix+Hib/Poliorix 2 Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 19.5 Months STANDARD_DEVIATION 0.93 | 19.4 Months STANDARD_DEVIATION 0.91 | 19.5 Months STANDARD_DEVIATION 0.97 | 19.47 Months STANDARD_DEVIATION 0.94 |
| Race/Ethnicity, Customized Asian-Chinese heritage | 272 Participants | 273 Participants | 280 Participants | 825 Participants |
| Sex: Female, Male Female | 131 Participants | 126 Participants | 120 Participants | 377 Participants |
| Sex: Female, Male Male | 141 Participants | 147 Participants | 160 Participants | 448 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 272 | 0 / 273 | 0 / 280 |
| other Total, other adverse events | 157 / 272 | 164 / 273 | 158 / 280 |
| serious Total, serious adverse events | 1 / 272 | 0 / 273 | 0 / 280 |
Outcome results
Primary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.174 IU/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.455 IU/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.189 IU/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.511 IU/mL |
| Control Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.154 IU/mL |
| Control Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.38 IU/mL |
Primary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.175 IU/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.45 IU/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.189 IU/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.509 IU/mL |
| Control Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.154 IU/mL |
| Control Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.38 IU/mL |
Primary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 1.341 IU/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 4.862 IU/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 1.504 IU/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 4.927 IU/mL |
| Control Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 1.227 IU/mL |
| Control Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 4.371 IU/mL |
Primary
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 56.5 Titers |
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 72 Titers |
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 72.6 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 64.1 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 96.3 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 79.4 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 75.9 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 60.3 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 41.9 Titers |
Primary
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 2 | 57.3 Titers |
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 1 | 72.3 Titers |
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 3 | 71.3 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 2 | 63.6 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 1 | 95.7 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 3 | 79.9 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 1 | 77.2 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 3 | 60.6 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-polio 2 | 42.6 Titers |
Primary
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 1931.2 Titers |
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 3512.2 Titers |
| Infanrix+Hib/Poliorix 1 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 5237.8 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 2237.9 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 3410.9 Titers |
| Infanrix+Hib/Poliorix 2 Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 5438.5 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 3386.8 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 5141.2 Titers |
| Control Group | Anti-polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 1886.1 Titers |
Primary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-PRP Antibody Concentrations | 2.308 µg/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PRP Antibody Concentrations | 2.743 µg/mL |
| Control Group | Anti-PRP Antibody Concentrations | 2.407 µg/mL |
Primary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-PRP Antibody Concentrations | 35.178 µg/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PRP Antibody Concentrations | 49.023 µg/mL |
| Control Group | Anti-PRP Antibody Concentrations | 27.682 µg/mL |
Primary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-PRP Antibody Concentrations | 2.275 µg/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PRP Antibody Concentrations | 2.674 µg/mL |
| Control Group | Anti-PRP Antibody Concentrations | 2.413 µg/mL |
Primary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 12.8 EL.U/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 10.3 EL.U/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 9.2 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 14.3 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 12.2 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 9.7 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 10.4 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 9 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 12.4 EL.U/mL |
Primary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 12.7 EL.U/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 10.3 EL.U/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 9.2 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 14.3 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 12.2 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 9.7 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 10.3 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 9 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 12.3 EL.U/mL |
Primary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-FHA | 124.6 EL.U/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-PT | 138.5 EL.U/mL |
| Infanrix+Hib/Poliorix 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-PRN | 57.3 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-FHA | 124 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-PT | 146.2 EL.U/mL |
| Infanrix+Hib/Poliorix 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-PRN | 59.9 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-PT | 126.8 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-PRN | 57.2 EL.U/mL |
| Control Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions | Anti-FHA | 120.8 EL.U/mL |
Primary
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA | 262 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT | 260 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN | 260 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA | 267 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT | 263 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN | 265 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT | 260 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN | 267 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA | 262 Participants |
Primary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 266 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 266 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 266 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 268 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 268 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 268 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 273 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 273 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 273 Participants |
Primary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 256 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 254 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 254 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 262 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 258 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 260 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 253 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 260 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 255 Participants |
Primary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-D | 265 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-T | 266 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-D | 268 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-T | 268 Participants |
| Control Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-D | 270 Participants |
| Control Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-T | 272 Participants |
Primary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-D | 235 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-T | 264 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-D | 245 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-T | 266 Participants |
| Control Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-D | 228 Participants |
| Control Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids | Anti-T | 268 Participants |
Primary
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was 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).
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D | 241 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T | 269 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D | 250 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T | 271 Participants |
| Control Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D | 234 Participants |
| Control Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T | 275 Participants |
Primary
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 2 | 248 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 1 | 259 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 3 | 254 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 3 | 259 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 1 | 267 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 2 | 261 Participants |
| Control Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 2 | 250 Participants |
| Control Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 3 | 257 Participants |
| Control Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 1 | 270 Participants |
Primary
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 2 | 265 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 1 | 265 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 3 | 265 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 2 | 268 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 1 | 268 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 3 | 268 Participants |
| Control Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 1 | 273 Participants |
| Control Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 3 | 273 Participants |
| Control Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-Polio 2 | 273 Participants |
Primary
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) | 226 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) | 234 Participants |
| Control Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP) | 241 Participants |
Primary
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | 221 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | 229 Participants |
| Control Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | 234 Participants |
Primary
Number of Seroprotected Subjects Against PRP
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects Against PRP | 264 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects Against PRP | 268 Participants |
| Control Group | Number of Seroprotected Subjects Against PRP | 271 Participants |
Primary
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Time frame: Before the booster vaccination (At Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 3 | 249 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 2 | 243 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 1 | 253 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 3 | 254 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 1 | 262 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 2 | 256 Participants |
| Control Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 2 | 244 Participants |
| Control Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 1 | 263 Participants |
| Control Group | Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3 | Anti-Polio 3 | 250 Participants |
Primary
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations \< cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Time frame: One month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 266 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 239 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 266 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 268 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 268 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 230 Participants |
| Control Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 272 Participants |
| Control Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 244 Participants |
| Control Group | Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 272 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 38 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 78 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 67 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 102 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 105 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 50 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 73 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 81 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 91 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 72 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 69 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 38 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 16 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 73 Participants |
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 19 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 15 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 10 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 74 Participants |
| Control Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 76 Participants |
| Control Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 14 Participants |
| Control Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 19 Participants |
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 (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 16 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 13 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 21 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 1)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix+Hib/Poliorix 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Infanrix+Hib/Poliorix 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |