Poliomyelitis, Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
Conditions
Keywords
Infanrix hexa, combined vaccine
Brief summary
The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study. The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.
Interventions
BIOLOGICALInfanrix™ penta
Subjects received a booster dose
BIOLOGICALInfanrix™ hexa
Subjects received a booster dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463). * A male or female between, and including 18 and 23 months of age at the time of the 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 other than the study vaccines 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 dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose. * Participation in another clinical study, between the primary study NCT00320463 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. * Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT00320463. * Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT00320463. * History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study NCT00320463. * 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. * Any of the following adverse events having occurred after previous administration of DTP vaccine: * Hypersensitivity reaction due to the vaccine. * Encephalopathy defined as an acute, severe central nervous system disorder of unknown etiology occurring within 7 days following previous vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. * Any of the following adverse events having occurred after previous administration of DTP vaccine: * Temperature of \>= 40.0 °C (axillary temperature), within 48 hours of vaccination. * Collapse or shock-like state within 48 hours of vaccination. * Persistent, inconsolable crying lasting \>= 3 hours, occurring within 48 hours of vaccination. * Convulsions with or without fever, occurring within 3 days of vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose | One month after the booster dose | Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL) |
| Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose | One month after the booster dose | Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL) |
| Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | One month after the booster dose | Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL) |
| Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | One month after the booster dose | Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50) |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | One month after the booster dose | Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-diphtheria and Anti-tetanus Antibodies Concentration | Before (Pre) and one month after (Post) the booster dose | Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Before (Pre) and one month after (Post) the booster dose | Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL |
| Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Before the booster dose administration (at baseline) | Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL |
| Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Before the booster dose | Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50 |
| Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | Before (Pre) and one month after (Post) the booster dose | Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes |
| Number of Subjects Reporting Solicited Symptoms | Within the 4-day (Day 0-3) post-vaccination period | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | Within the 31-day (Day 0-30) post-vaccination period | An AE is 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. |
| Number of Subjects Reporting Serious Adverse Events (SAE) | Up to one month after the booster dose administration | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above |
| Anti-poliovirus Antibodies Titer | Before (Pre) and one month after (Post) the booster dose | Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT) |
| Anti-HB Antibodies Concentration | Before (Pre) and one month after (Post) the booster dose | Concentration of anti-HB antibodies given as GMC in mIU/mL |
| Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | Before (Pre) and one month after (Post) the booster dose | Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes |
| Anti-PRP Antibodies Concentration | Before (Pre) and one month after (Post) the booster dose | Concentration of anti-PRP antibodies given as GMC in µg/mL |
| Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose | Before the booster dose administration (at baseline) | Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infanrix Hexa Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix hexa | 111 |
| Infanrix Hexa Preservative-containing Formulation Group Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa | 115 |
| Infanrix Penta Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix penta | 57 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Infanrix Hexa Preservative-free Formulation Group | Infanrix Hexa Preservative-containing Formulation Group | Infanrix Penta Preservative-free Formulation Group | Total |
|---|---|---|---|---|
| Age, Continuous | 21.2 months STANDARD_DEVIATION 1.61 | 21.3 months STANDARD_DEVIATION 1.57 | 21.2 months STANDARD_DEVIATION 1.62 | 21.2 months STANDARD_DEVIATION 1.59 |
| Race/Ethnicity, Customized White - Caucasian/European Heritage | 111 Participants | 115 Participants | 57 Participants | 283 Participants |
| Sex: Female, Male Female | 56 Participants | 46 Participants | 35 Participants | 137 Participants |
| Sex: Female, Male Male | 55 Participants | 69 Participants | 22 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 115 | 0 / 57 |
| other Total, other adverse events | 59 / 111 | 62 / 115 | 26 / 57 |
| serious Total, serious adverse events | 0 / 111 | 0 / 115 | 0 / 57 |
Outcome results
Primary
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose
Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)
Time frame: One month after the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-FHA | 476.6 EL.U/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-PT | 65.5 EL.U/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-PRN | 418.1 EL.U/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-FHA | 428.3 EL.U/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-PT | 84.2 EL.U/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-PRN | 384.1 EL.U/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-PT | 43.9 EL.U/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-PRN | 251.6 EL.U/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose | Anti-FHA | 221.1 EL.U/mL |
Primary
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)
Time frame: One month after the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-diphtheria | 76 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-tetanus | 76 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-diphtheria | 76 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-tetanus | 78 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-diphtheria | 40 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-tetanus | 42 subjects |
Primary
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose
Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)
Time frame: One month after the booster dose
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose | 88 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose | 92 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose | 48 subjects |
Primary
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)
Time frame: One month after the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 2 | 55 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 1 | 55 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 3 | 55 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 2 | 51 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 1 | 51 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 3 | 52 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 1 | 31 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 3 | 29 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose | Anti-poliovirus type 2 | 30 subjects |
Primary
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose
Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)
Time frame: One month after the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose | 74 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose | 78 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose | 27 subjects |
Secondary
Anti-diphtheria and Anti-tetanus Antibodies Concentration
Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL
Time frame: Before (Pre) and one month after (Post) the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-diphtheria Pre | 0.2 IU/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-diphtheria Post | 2.7 IU/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-tetanus Pre | 0.5 IU/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-tetanus Post | 4.9 IU/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-tetanus Post | 6.9 IU/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-diphtheria Pre | 0.2 IU/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-tetanus Pre | 0.5 IU/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-diphtheria Post | 3.4 IU/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-tetanus Post | 4.5 IU/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-diphtheria Post | 2.2 IU/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-tetanus Pre | 0.3 IU/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-diphtheria and Anti-tetanus Antibodies Concentration | Anti-diphtheria Pre | 0.1 IU/mL |
Secondary
Anti-HB Antibodies Concentration
Concentration of anti-HB antibodies given as GMC in mIU/mL
Time frame: Before (Pre) and one month after (Post) the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Anti-HB Antibodies Concentration | Pre | 163.5 mIU/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-HB Antibodies Concentration | Post | 4668.0 mIU/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-HB Antibodies Concentration | Pre | 161.2 mIU/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-HB Antibodies Concentration | Post | 4962.3 mIU/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-HB Antibodies Concentration | Pre | 196.9 mIU/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-HB Antibodies Concentration | Post | 3867.8 mIU/mL |
Secondary
Anti-poliovirus Antibodies Titer
Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)
Time frame: Before (Pre) and one month after (Post) the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 2 Pre | 144.4 titer |
| Infanrix Hexa Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 1 Pre | 106.5 titer |
| Infanrix Hexa Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 2 Post | 1412.0 titer |
| Infanrix Hexa Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 3 Post | 1485.9 titer |
| Infanrix Hexa Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 1 Post | 1237.1 titer |
| Infanrix Hexa Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 3 Pre | 98.7 titer |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 1 Post | 1939.8 titer |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 1 Pre | 120.4 titer |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 2 Pre | 102.5 titer |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 2 Post | 1900.6 titer |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 3 Pre | 68.9 titer |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 3 Post | 1828.7 titer |
| Infanrix Penta Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 1 Post | 979.5 titer |
| Infanrix Penta Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 3 Post | 605.6 titer |
| Infanrix Penta Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 3 Pre | 77.5 titer |
| Infanrix Penta Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 2 Pre | 95.3 titer |
| Infanrix Penta Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 1 Pre | 85.9 titer |
| Infanrix Penta Preservative-free Formulation Group | Anti-poliovirus Antibodies Titer | Anti-poliovirus type 2 Post | 916.3 titer |
Secondary
Anti-PRP Antibodies Concentration
Concentration of anti-PRP antibodies given as GMC in µg/mL
Time frame: Before (Pre) and one month after (Post) the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Anti-PRP Antibodies Concentration | Pre | 0.3 µg/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-PRP Antibodies Concentration | Post | 25.3 µg/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-PRP Antibodies Concentration | Pre | 0.4 µg/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-PRP Antibodies Concentration | Post | 34.7 µg/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-PRP Antibodies Concentration | Pre | 0.2 µg/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-PRP Antibodies Concentration | Post | 0.4 µg/mL |
Secondary
Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose
Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL
Time frame: Before the booster dose administration (at baseline)
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-FHA | 24.5 EL.U/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-PT | 6.6 EL.U/mL |
| Infanrix Hexa Preservative-free Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-PRN | 17.5 EL.U/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-FHA | 22.1 EL.U/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-PT | 6.2 EL.U/mL |
| Infanrix Hexa Preservative-containing Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-PRN | 13.7 EL.U/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-PT | 7.1 EL.U/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-PRN | 15.0 EL.U/mL |
| Infanrix Penta Preservative-free Formulation Group | Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose | Anti-FHA | 23.8 EL.U/mL |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above
Time frame: Up to one month after the booster dose administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 0 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 0 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 0 subjects |
Secondary
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite
Time frame: Within the 4-day (Day 0-3) post-vaccination period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Swelling | 39 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Loss of appetite | 22 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Fever | 18 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness | 21 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Redness | 54 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Pain | 35 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Irritability | 21 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness | 18 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Solicited Symptoms | Pain | 36 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Solicited Symptoms | Redness | 54 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Solicited Symptoms | Swelling | 45 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Solicited Symptoms | Fever | 15 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Solicited Symptoms | Irritability | 21 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Solicited Symptoms | Loss of appetite | 14 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Fever | 6 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Redness | 22 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Loss of appetite | 5 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Irritability | 4 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness | 8 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Swelling | 19 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Solicited Symptoms | Pain | 14 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is 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.
Time frame: Within the 31-day (Day 0-30) post-vaccination period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 8 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 9 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 2 subjects |
Secondary
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose
Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL
Time frame: Before the booster dose administration (at baseline)
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-diphtheria | 45 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-tetanus | 69 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-diphtheria | 47 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-tetanus | 62 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-diphtheria | 23 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-tetanus | 39 subjects |
Secondary
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose
Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes
Time frame: Before (Pre) and one month after (Post) the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 100 mIU/mL Pre | 57 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 10 mIU/mL Pre | 87 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 100 mIU/mL Post | 85 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 100 mIU/mL Pre | 57 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 10 mIU/mL Pre | 86 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 100 mIU/mL Post | 87 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 10 mIU/mL Pre | 44 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 100 mIU/mL Post | 39 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 100 mIU/mL Pre | 35 subjects |
Secondary
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose
Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50
Time frame: Before the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 2 | 46 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 1 | 46 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 3 | 47 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 2 | 48 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 1 | 47 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 3 | 48 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 1 | 24 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 3 | 23 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose | Anti-poliovirus type 2 | 26 subjects |
Secondary
Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose
Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes
Time frame: Before (Pre) and one month after (Post) the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 1.0 µg/mL Pre | 12 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 0.15 µg/mL Pre | 55 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 1.0 µg/mL Post | 69 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 1.0 µg/mL Pre | 14 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 0.15 µg/mL Pre | 55 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 1.0 µg/mL Post | 74 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 0.15 µg/mL Pre | 23 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 1.0 µg/mL Post | 9 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose | ≥ 1.0 µg/mL Pre | 7 subjects |
Secondary
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose
Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL
Time frame: Before (Pre) and one month after (Post) the booster dose
Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PT Pre | 45 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PT Post | 79 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-FHA Pre | 77 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-FHA Post | 86 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PRN Pre | 75 subjects |
| Infanrix Hexa Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PRN Post | 88 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PRN Post | 77 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PT Pre | 43 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-FHA Post | 69 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PRN Pre | 67 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PT Post | 66 subjects |
| Infanrix Hexa Preservative-containing Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-FHA Pre | 68 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PT Post | 25 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-FHA Pre | 39 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PRN Post | 40 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-FHA Post | 37 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PT Pre | 26 subjects |
| Infanrix Penta Preservative-free Formulation Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose | Anti-PRN Pre | 35 subjects |