Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis, Tetanus
Conditions
Keywords
Hexavalent vaccine, Booster
Brief summary
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
Detailed description
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
Interventions
BIOLOGICALInfanrix Hexa
Vaccine administered as a booster dose at 16-20 months of age
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Months to 20 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol * Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786. * A male or female between, and including, 16 and 20 months of age at the time of booster vaccination. * Written informed consent obtained from the parent or guardian of the subject * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of 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 vaccine dose. * Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose. * Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Before the booster administration (At Month 0) | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). |
| Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Before the booster vaccination (At Month 0) | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. |
| Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Before the booster vaccination (At Month 0) | A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8. |
| Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Before the booster vaccination (At Month 0) | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Before the booster vaccination (At Month 0) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. |
| Number of Subjects With a Vaccine Response to PT, FHA and PR | One month after the booster vaccination (At Month 1) | Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value). |
| Anti-D and Anti-T Antibody Concentrations | Before the booster vaccination (At Month 0) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Before the booster vaccination (At Month 0) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. |
| Anti-HBs Antibody Concentrations | Before the booster vaccination (At Month 0) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. |
| Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Before the booster vaccination (At Month 0) | Antibody titers were presented as geometric mean titers (GMTs). |
| Anti-PRP Antibody Concentrations | Before the booster vaccination (At Month 0) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after the booster vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 4-day (Days 0-3) follow-up period after the booster vaccination | Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Before (Month 0) and one month after (Month 1) the booster vaccination | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL . |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 1, during the entire study period | Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects Reporting Concomitant Medications | During the 4-day (Days 0-3) follow-up period after the booster vaccination | — |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-30) follow-up period after the booster vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Before (Month 0) and one month after (Month 1) the booster vaccination | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL. |
| Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Before (Month 0) and one month after (Month 1) the booster vaccination | A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8. |
| Number of Seroprotected Subjects Against PT, FHA and PRN | Before (Month 0) and one month after (Month 1) the booster vaccination | A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL . |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Before (Month 0) and one month after (Month 1) the booster vaccination | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL. |
| Anti-D and Anti-T Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. |
| Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. |
| Anti-HBs Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. |
| Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). |
| Anti-PRP Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. |
| Number of Subjects With a Vaccine Response to PT, FHA and PR | One month after the booster dose (At Month 1) | Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations \< cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations \> cut-off value). |
Countries
Finland
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Infanrix Hexa PF Group Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 127 |
| Infanrix Hexa PC Group Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 137 |
| Control Group Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | 139 |
| Total | 403 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Migrated from study area | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 6 | 5 |
Baseline characteristics
| Characteristic | Infanrix Hexa PF Group | Infanrix Hexa PC Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 17.9 Months STANDARD_DEVIATION 1.12 | 18 Months STANDARD_DEVIATION 1.03 | 17.8 Months STANDARD_DEVIATION 1.11 | 17.90 Months STANDARD_DEVIATION 1.09 |
| Race/Ethnicity, Customized Geographic ancestry Not specified | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Arabic/North African heritage | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Caucasian/European heritage | 125 Participants | 134 Participants | 135 Participants | 394 Participants |
| Sex: Female, Male Female | 56 Participants | 66 Participants | 59 Participants | 181 Participants |
| Sex: Female, Male Male | 71 Participants | 71 Participants | 80 Participants | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 137 | 0 / 139 |
| other Total, other adverse events | 116 / 127 | 126 / 137 | 129 / 139 |
| serious Total, serious adverse events | 1 / 127 | 2 / 137 | 1 / 139 |
Outcome results
Primary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.064 IU/mL |
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.216 IU/mL |
| Infanrix Hexa PC Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 0.069 IU/mL |
| Infanrix Hexa PC Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 0.248 IU/mL |
Primary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in 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 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 2.237 IU/mL |
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 9.799 IU/mL |
| Infanrix Hexa PC Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 2.242 IU/mL |
| Infanrix Hexa PC Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 9.136 IU/mL |
Primary
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa PF Group | Anti-HBs Antibody Concentrations | 84.3 mIU/mL |
| Infanrix Hexa PC Group | Anti-HBs Antibody Concentrations | 86.2 mIU/mL |
Primary
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/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 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa PF Group | Anti-HBs Antibody Concentrations | 3291.7 mIU/mL |
| Infanrix Hexa PC Group | Anti-HBs Antibody Concentrations | 3528.1 mIU/mL |
Primary
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
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 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 1 | 726.3 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 2 | 712.8 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 3 | 780 Titers |
| Infanrix Hexa PC Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 1 | 942.4 Titers |
| Infanrix Hexa PC Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 2 | 812.9 Titers |
| Infanrix Hexa PC Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 3 | 1145.8 Titers |
Primary
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 1 | 12.9 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 2 | 9.1 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 3 | 9.5 Titers |
| Infanrix Hexa PC Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 1 | 15.2 Titers |
| Infanrix Hexa PC Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 2 | 8.7 Titers |
| Infanrix Hexa PC Group | Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers | Anti-polio 3 | 16 Titers |
Primary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa PF Group | Anti-PRP Antibody Concentrations | 0.249 µg/mL |
| Infanrix Hexa PC Group | Anti-PRP Antibody Concentrations | 0.314 µg/mL |
Primary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in 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 were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa PF Group | Anti-PRP Antibody Concentrations | 36.866 µg/mL |
| Infanrix Hexa PC Group | Anti-PRP Antibody Concentrations | 35.318 µg/mL |
Primary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 7.8 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 21.7 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 8.6 EL.U/mL |
| Infanrix Hexa PC Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 7 EL.U/mL |
| Infanrix Hexa PC Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 22.1 EL.U/mL |
| Infanrix Hexa PC Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 8.7 EL.U/mL |
Primary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: One month 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 were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 150.9 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 609.6 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 308.5 EL.U/mL |
| Infanrix Hexa PC Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 117.1 EL.U/mL |
| Infanrix Hexa PC Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 533.7 EL.U/mL |
| Infanrix Hexa PC Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 311.7 EL.U/mL |
Primary
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a 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 administration (At Month 0)
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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D | 22 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T | 93 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D | 35 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T | 103 Participants |
Primary
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D | 112 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T | 113 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D | 118 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T | 118 Participants |
Primary
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti-HBs ≥ 10 mIU/mL | 110 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti HBs ≥ 100 mIU/mL | 105 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti-HBs ≥ 10 mIU/mL | 117 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti HBs ≥ 100 mIU/mL | 113 Participants |
Primary
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti-HBs ≥ 10 mIU/mL | 106 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti HBs ≥ 100 mIU/mL | 55 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti-HBs ≥ 10 mIU/mL | 112 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti HBs ≥ 100 mIU/mL | 54 Participants |
Primary
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
A seroprotected subject was defined as a 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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT | 111 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA | 112 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN | 113 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT | 118 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA | 118 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN | 117 Participants |
Primary
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT | 80 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA | 106 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN | 81 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PT | 81 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-FHA | 107 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) | Anti-PRN | 86 Participants |
Primary
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 1 | 67 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 2 | 48 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 3 | 58 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 1 | 76 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 2 | 51 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 3 | 77 Participants |
Primary
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value 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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 1 | 110 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 2 | 110 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 3 | 111 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 1 | 117 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 2 | 117 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 3 | 117 Participants |
Primary
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 0.15 µg/mL | 112 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 1.0 µg/mL | 111 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 0.15 µg/mL | 119 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 1.0 µg/mL | 117 Participants |
Primary
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time frame: Before the booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 0.15μg/mL | 71 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 1.0μg/mL | 15 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 0.15μg/mL | 87 Participants |
| Infanrix Hexa PC Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 1.0μg/mL | 23 Participants |
Primary
Number of Subjects With a Vaccine Response to PT, FHA and PR
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value).
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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, S+ | 104 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, Total | 108 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, Total | 107 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, S- | 31 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, S+ | 78 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, S+ | 81 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, S- | 4 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, Total | 112 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, S- | 29 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, Total | 115 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, S- | 30 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, S+ | 81 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, Total | 111 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, S- | 4 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, Total | 110 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, S- | 30 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, S+ | 85 Participants |
| Infanrix Hexa PC Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, S+ | 106 Participants |
Secondary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.084 IU/mL |
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 3.952 IU/mL |
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.261 IU/mL |
| Infanrix Hexa PF Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 10.833 IU/mL |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 139.8 mIU/mL |
| Infanrix Hexa PF Group | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 6132.7 mIU/mL |
Secondary
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Anti-polio 1, M0 | 21.6 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Anti-polio 1, M1 | 1288.8 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Anti-polio 2, M0 | 11.8 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Anti-polio 2, M1 | 1231 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Anti-polio 3, M0 | 21.3 Titers |
| Infanrix Hexa PF Group | Anti-poliovirus Type 1, 2 and 3 Antibody Titers | Anti-polio 3, M1 | 1794.8 Titers |
Secondary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.487 µg/mL |
| Infanrix Hexa PF Group | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 77.087 µg/mL |
Secondary
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT, M0 | 8.9 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT, M1 | 153.7 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 33.7 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-FHA, M1 | 791.9 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 15.3 EL.U/mL |
| Infanrix Hexa PF Group | Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PRN, M1 | 564.1 EL.U/mL |
Secondary
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D, M0 | 40 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-D, M1 | 119 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T, M0 | 95 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids | Anti-T, M1 | 119 Participants |
Secondary
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti-HBs ≥ 10 mIU/mL, M0 | 106 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti-HBs ≥ 10 mIU/mL, M1 | 118 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti HBs ≥ 100 mIU/mL, M0 | 67 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | Anti HBs ≥ 100 mIU/mL, M1 | 114 Participants |
Secondary
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 1, M0 | 84 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 1, M1 | 112 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 2, M0 | 56 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 2, M1 | 112 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 3, M0 | 82 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 | Anti-polio 3, M1 | 113 Participants |
Secondary
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 0.15 μg/mL, M0 | 92 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 0.15 μg/mL, M1 | 119 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 1.0 μg/mL, M0 | 32 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) | Anti-PRP ≥ 1.0 μg/mL, M1 | 118 Participants |
Secondary
Number of Seroprotected Subjects Against PT, FHA and PRN
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against PT, FHA and PRN | Anti-PT, M0 | 93 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against PT, FHA and PRN | Anti-PT, M1 | 119 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against PT, FHA and PRN | Anti-FHA, M0 | 109 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against PT, FHA and PRN | Anti-FHA, M1 | 119 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against PT, FHA and PRN | Anti-PRN, M0 | 99 Participants |
| Infanrix Hexa PF Group | Number of Seroprotected Subjects Against PT, FHA and PRN | Anti-PRN, M1 | 119 Participants |
Secondary
Number of Subjects Reporting Concomitant Medications
Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Subjects Reporting Concomitant Medications | Any concomitant medication | 105 Participants |
| Infanrix Hexa PF Group | Number of Subjects Reporting Concomitant Medications | Any antipyretic | 34 Participants |
| Infanrix Hexa PC Group | Number of Subjects Reporting Concomitant Medications | Any concomitant medication | 111 Participants |
| Infanrix Hexa PC Group | Number of Subjects Reporting Concomitant Medications | Any antipyretic | 35 Participants |
| Control Group | Number of Subjects Reporting Concomitant Medications | Any concomitant medication | 116 Participants |
| Control Group | Number of Subjects Reporting Concomitant Medications | Any antipyretic | 33 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 50 Participants |
| Infanrix Hexa PF Group | Number of Subjects With Any Solicited General Symptoms | Any Fever (Rectal) | 22 Participants |
| Infanrix Hexa PF Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 68 Participants |
| Infanrix Hexa PF Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of Appetite | 37 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of Appetite | 46 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 48 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 86 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Any Solicited General Symptoms | Any Fever (Rectal) | 34 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of Appetite | 45 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Fever (Rectal) | 31 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 78 Participants |
| Control Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 58 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) follow-up period after the booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 66 Participants |
| Infanrix Hexa PF Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 74 Participants |
| Infanrix Hexa PF Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 44 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 76 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 79 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 53 Participants |
| Control Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 82 Participants |
| Control Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 60 Participants |
| Control Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 94 Participants |
Secondary
Number of Subjects With a Vaccine Response to PT, FHA and PR
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations \< cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations \> cut-off value).
Time frame: One month after the booster dose (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 were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, S- | 17 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, S+ | 93 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PT, Total | 110 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, S- | 0 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, S+ | 105 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-FHA, Total | 105 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, S- | 12 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, S+ | 98 Participants |
| Infanrix Hexa PF Group | Number of Subjects With a Vaccine Response to PT, FHA and PR | Anti-PRN, Total | 110 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 1, during the entire study period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa PF Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Day 0-30) follow-up period after the booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa PF Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 51 Participants |
| Infanrix Hexa PC Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 54 Participants |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 61 Participants |