Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus, Acellular Pertussis, Hepatitis B
Conditions
Keywords
Infants, Safety, Healthy, Infanrix Hexa, Immunogenicity
Brief summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.
Interventions
BIOLOGICALInfanrix hexa
3 doses administered intramuscularly in the right thigh.
BIOLOGICALPediarix
3 doses administered intramuscularly in the right thigh
BIOLOGICALActHIB
4 doses administered intramuscularly in the upper left thigh
BIOLOGICALPentacel
4 doses administered intramuscularly in the right thigh
BIOLOGICALEngerix-B
2 or 3 doses administered intramuscularly in the upper left thigh
BIOLOGICALInfanrix
1 dose administered intramuscularly in the right thigh
BIOLOGICALHiberix
1 dose administered intramuscularly in the left thigh
BIOLOGICALPrevnar13
3 doses administered intramuscularly in the lower left thigh
BIOLOGICALRotarix
2 doses administered orally
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks \[259 to 293 days\]). * Written informed consent obtained from parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
Exclusion criteria
* Child in care * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study: * Inactivated influenza and hepatitis A vaccines are allowed throughout the study. * Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases. * Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including yeast). * Hypersensitivity to latex. * Major congenital defects or serious chronic illness. * History of any neurological disorders including seizures. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. * History of Severe Combined Immunodeficiency Disease (SCID). * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred route for recording temperature in this study will be rectal for Epoch 001 and axillary for Epoch 002. * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | At Month 5, one month after the third dose of the primary vaccination. | Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Tetanus (T). | At Month 5, one month after the third dose of the primary vaccination. | A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL. |
| Number of Seroprotected Subjects Against Diphtheria (D). | At Month 5, one month after the third dose of the primary vaccination. | A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL. |
| Antibody Concentrations for Anti-T. | At Month 5, one month after the third dose of the primary vaccination | Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL. |
| Antibody Concentrations for Anti-D. | At Month 5, one month after the third dose of the primary vaccination | Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL. |
| Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | At Month 5, one month after the third dose of the primary vaccination | A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution. |
| Antibody Titres for Anti-polio Types 1, 2 and 3. | At Month 5, one month after the third dose of the primary vaccination | Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution. |
| Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP). | At Month 5, one month after the third dose of the primary vaccination | A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL. |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | At Month 5, one month after the third dose of the primary vaccination | The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL. |
| Antibody Concentrations for Anti-PRP. | At Month 5, one month after the third dose of the primary vaccination | Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL. |
| Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs). | At Month 5, one month after the third dose of the primary vaccination | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL). |
| Antibody Concentrations for Anti-HBs. | At Month 5, one month after the third dose of the primary vaccination | Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL. |
| Number of Subjects With Solicited Local Symptoms. | During the 4-day (Days 0-3) post-vaccination period following Dose 1 | The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA. |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | At Month 5, one month after the third dose of the primary vaccination. | A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. |
| Number of Subjects With Specific Adverse Events (AEs). | From Month 0 up to 6 months post primary-vaccination (Month 10) | Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies) |
| Number of Subjects With Unsolicited AEs. | During the 31-day (Days 0-30) post-primary vaccination period. | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. |
| Number of Subjects With Serious Adverse Events (SAEs). | From Month 0 up to 6 months post-primary vaccination (Month 10) | SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Seroprotected Subjects Against Anti-T. | At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)] | A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL. |
| Number of Seroprotected Subjects Against Anti-D. | At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)] | A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL. |
| Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)] | Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. |
| Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)] | Booster response to PT, FHA and PRN antigens was defined as: * For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off. * For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration. * For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration. The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. |
| Number of Seroprotected Subjects Against Anti-PRP. | At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)] | A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL. |
| Number of Seroprotected Subjects Against Anti-HBs. | At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. |
| Number of Subjects With Specific AEs. | During the 31-day (Days 0-30) post-booster vaccination. | Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies) |
| Number of Subjects With SAEs. | During the 31-day (Days 0-30) post-booster vaccination. | SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Subjects With Solicited General Symptoms. | During the 4-day (Days 0-3) post-vaccination period following Dose 1. | The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination. |
Countries
United States
Participant flow
Recruitment details
This study was conducted in 43 centers in the United States of America (USA).
Participants by arm
| Arm | Count |
|---|---|
| Infanrix Hexa Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and Hiberix at 15-18 months of age by intramuscular injection in the anterolateral thigh. | 195 |
| Pediarix Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Infanrix and ActHIB at 15-18 months of age by intramuscular injection in the anterolateral thigh. | 194 |
| Pentacel Group Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel and Engerix co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix was administered orally. Subjects received a booster dose of Pentacel at 15-18 months of age by intramuscular injection in the anterolateral thigh. | 196 |
| Total | 585 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 14 | 18 | 15 |
| Overall Study | Other | 7 | 9 | 6 |
| Overall Study | Protocol Violation | 7 | 2 | 8 |
| Overall Study | Sponsor study termination | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 7 | 8 |
Baseline characteristics
| Characteristic | Infanrix Hexa Group | Pediarix Group | Pentacel Group | Total |
|---|---|---|---|---|
| Age, Continuous | 8.5 Weeks STANDARD_DEVIATION 1 | 8.6 Weeks STANDARD_DEVIATION 1.1 | 8.6 Weeks STANDARD_DEVIATION 1.1 | 8.6 Weeks STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized African Heritage / African American | 16 Participants | 9 Participants | 20 Participants | 45 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 15 Participants | 15 Participants | 17 Participants | 47 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 9 Participants | 9 Participants | 8 Participants | 26 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Unspecified | 29 Participants | 27 Participants | 32 Participants | 88 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 118 Participants | 128 Participants | 115 Participants | 361 Participants |
| Sex: Female, Male Female | 101 Participants | 80 Participants | 95 Participants | 276 Participants |
| Sex: Female, Male Male | 94 Participants | 114 Participants | 101 Participants | 309 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 195 | 0 / 194 | 0 / 196 |
| other Total, other adverse events | 188 / 195 | 190 / 194 | 187 / 196 |
| serious Total, serious adverse events | 8 / 195 | 1 / 194 | 8 / 196 |
Outcome results
Primary
Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-FHA | 106.3 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-PT | 43.2 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-PRN | 57.4 IU/mL |
| Pediarix Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-FHA | 122.7 IU/mL |
| Pediarix Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-PT | 48.3 IU/mL |
| Pediarix Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-PRN | 46.9 IU/mL |
| Pentacel Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-PT | 24.2 IU/mL |
| Pentacel Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-PRN | 33.0 IU/mL |
| Pentacel Group | Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN). | Anti-FHA | 59.9 IU/mL |
Comparison: To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.95% CI: [0.92, 1.31]
Comparison: To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.95% CI: [0.97, 1.35]
Comparison: To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.95% CI: [0.63, 0.99]
Secondary
Antibody Concentrations for Anti-D.
Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-D. | Anti-D at Visit 5 | 0.701 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-D. | Anti-D at Visit 6 | 8.334 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-D. | Anti-D at Visit 5 | 0.622 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-D. | Anti-D at Visit 6 | 7.886 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-D. | Anti-D at Visit 5 | 0.764 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-D. | Anti-D at Visit 6 | 8.537 IU/mL |
Secondary
Antibody Concentrations for Anti-D.
Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-D. | 1.777 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-D. | 1.648 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-D. | 1.249 IU/mL |
Secondary
Antibody Concentrations for Anti-HBs.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-HBs. | 328.7 mIU/mL |
| Pediarix Group | Antibody Concentrations for Anti-HBs. | 235.8 mIU/mL |
| Pentacel Group | Antibody Concentrations for Anti-HBs. | 149.4 mIU/mL |
Secondary
Antibody Concentrations for Anti-HBs.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-HBs. | 2258.8 mIU/mL |
| Pediarix Group | Antibody Concentrations for Anti-HBs. | 1886.0 mIU/mL |
| Pentacel Group | Antibody Concentrations for Anti-HBs. | 1053.4 mIU/mL |
Secondary
Antibody Concentrations for Anti-PRP.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-PRP. | Anti-PRP at Visit 5 | 0.301 µg/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-PRP. | Anti-PRP at Visit 6 | 39.365 µg/mL |
| Pediarix Group | Antibody Concentrations for Anti-PRP. | Anti-PRP at Visit 5 | 0.987 µg/mL |
| Pediarix Group | Antibody Concentrations for Anti-PRP. | Anti-PRP at Visit 6 | 51.140 µg/mL |
| Pentacel Group | Antibody Concentrations for Anti-PRP. | Anti-PRP at Visit 5 | 0.614 µg/mL |
| Pentacel Group | Antibody Concentrations for Anti-PRP. | Anti-PRP at Visit 6 | 27.318 µg/mL |
Secondary
Antibody Concentrations for Anti-PRP.
Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-PRP. | 1.348 µg/mL |
| Pediarix Group | Antibody Concentrations for Anti-PRP. | 9.258 µg/mL |
| Pentacel Group | Antibody Concentrations for Anti-PRP. | 5.717 µg/mL |
Secondary
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT Visit 5 | 5.3 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT Visit 6 | 71.4 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN Visit 5 | 6.8 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA Visit 6 | 186.9 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN Visit 6 | 208.0 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA Visit 5 | 17.1 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN Visit 5 | 5.5 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA Visit 6 | 250.4 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT Visit 5 | 6.5 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA Visit 5 | 21.8 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT Visit 6 | 87.6 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN Visit 6 | 215.6 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN Visit 6 | 130.5 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT Visit 6 | 55.5 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA Visit 6 | 101.0 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT Visit 5 | 3.1 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN Visit 5 | 6.0 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA Visit 5 | 8.1 IU/mL |
Secondary
Antibody Concentrations for Anti-T.
Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-T. | 2.458 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-T. | 2.633 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-T. | 2.012 IU/mL |
Secondary
Antibody Concentrations for Anti-T.
Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Group | Antibody Concentrations for Anti-T. | Anti-T at Visit 5 | 0.327 IU/mL |
| Infanrix Hexa Group | Antibody Concentrations for Anti-T. | Anti-T at Visit 6 | 9.212 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-T. | Anti-T at Visit 5 | 0.402 IU/mL |
| Pediarix Group | Antibody Concentrations for Anti-T. | Anti-T at Visit 6 | 8.870 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-T. | Anti-T at Visit 5 | 0.340 IU/mL |
| Pentacel Group | Antibody Concentrations for Anti-T. | Anti-T at Visit 6 | 6.880 IU/mL |
Secondary
Antibody Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 722.2 titres |
| Infanrix Hexa Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 483.5 titres |
| Infanrix Hexa Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 546.9 titres |
| Pediarix Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 927.0 titres |
| Pediarix Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 604.1 titres |
| Pediarix Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 567.7 titres |
| Pentacel Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 283.0 titres |
| Pentacel Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 319.5 titres |
| Pentacel Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 294.6 titres |
Secondary
Antibody Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix Hexa Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 94.9 titres |
| Infanrix Hexa Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 99.5 titres |
| Infanrix Hexa Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 122.1 titres |
| Pediarix Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 111.9 titres |
| Pediarix Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 107.4 titres |
| Pediarix Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 160.4 titres |
| Pentacel Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 42.2 titres |
| Pentacel Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 28.4 titres |
| Pentacel Group | Antibody Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 51.2 titres |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Visit 5 | 107 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Visit 5 | 130 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Visit 5 | 110 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Visit 6 | 138 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Visit 6 | 138 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Visit 6 | 136 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Visit 6 | 136 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Visit 5 | 114 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Visit 6 | 136 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Visit 6 | 136 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Visit 5 | 130 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Visit 5 | 104 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Visit 5 | 113 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Visit 5 | 91 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN at Visit 6 | 124 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Visit 6 | 126 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT at Visit 5 | 63 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA at Visit 6 | 126 Participants |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 146 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 146 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 146 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 149 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 148 Participants |
| Pediarix Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 148 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 148 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 148 Participants |
| Pentacel Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 149 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-D.
A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-D. | Anti-D at Visit 5 | 128 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-D. | Anti-D at Visit 6 | 138 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-D. | Anti-D at Visit 5 | 123 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-D. | Anti-D at Visit 6 | 136 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-D. | Anti-D at Visit 5 | 115 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-D. | Anti-D at Visit 6 | 126 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-HBs.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-HBs. | 131 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-HBs. | 128 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-HBs. | 105 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 119 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 124 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 123 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 122 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 121 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 126 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 100 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 80 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 109 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 133 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 137 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 129 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 131 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 134 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 132 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 1 | 135 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 3 | 124 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3. | Anti-polio 2 | 134 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-PRP.
A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-PRP. | Anti-PRP at Visit 5 | 91 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-PRP. | Anti-PRP at Visit 6 | 138 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-PRP. | Anti-PRP at Visit 5 | 122 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-PRP. | Anti-PRP at Visit 6 | 139 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-PRP. | Anti-PRP at Visit 5 | 94 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-PRP. | Anti-PRP at Visit 6 | 129 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-T.
A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-T. | Anti-T at Visit 5 | 118 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-T. | Anti-T at Visit 6 | 138 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-T. | Anti-T at Visit 5 | 123 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Anti-T. | Anti-T at Visit 6 | 136 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-T. | Anti-T at Visit 5 | 107 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Anti-T. | Anti-T at Visit 6 | 125 Participants |
Secondary
Number of Seroprotected Subjects Against Diphtheria (D).
A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Diphtheria (D). | 142 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Diphtheria (D). | 144 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Diphtheria (D). | 149 Participants |
Secondary
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL).
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs). | 134 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs). | 138 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs). | 133 Participants |
Secondary
Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).
A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP). | 146 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP). | 151 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP). | 154 Participants |
Secondary
Number of Seroprotected Subjects Against Tetanus (T).
A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Tetanus (T). | 146 Participants |
| Pediarix Group | Number of Seroprotected Subjects Against Tetanus (T). | 149 Participants |
| Pentacel Group | Number of Seroprotected Subjects Against Tetanus (T). | 148 Participants |
Secondary
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.
Booster response to PT, FHA and PRN antigens was defined as: * For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off. * For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration. * For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration. The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 130 Participants |
| Infanrix Hexa Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 126 Participants |
| Infanrix Hexa Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 128 Participants |
| Pediarix Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 127 Participants |
| Pediarix Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 121 Participants |
| Pediarix Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 128 Participants |
| Pentacel Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 111 Participants |
| Pentacel Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 112 Participants |
| Pentacel Group | Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 114 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Population: The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | Anti-PRP at Visit 5 | 23 Participants |
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | Anti-PRP at Visit 6 | 136 Participants |
| Pediarix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | Anti-PRP at Visit 5 | 71 Participants |
| Pediarix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | Anti-PRP at Visit 6 | 138 Participants |
| Pentacel Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | Anti-PRP at Visit 5 | 47 Participants |
| Pentacel Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | Anti-PRP at Visit 6 | 128 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Population: The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | 85 Participants |
| Pediarix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | 145 Participants |
| Pentacel Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL. | 130 Participants |
Secondary
Number of Subjects With SAEs.
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: During the 31-day (Days 0-30) post-booster vaccination.
Population: The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects With SAEs. | 1 Participants |
| Pediarix Group | Number of Subjects With SAEs. | 0 Participants |
| Pentacel Group | Number of Subjects With SAEs. | 1 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs).
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: From Month 0 up to 6 months post-primary vaccination (Month 10)
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Serious Adverse Events (SAEs). | 7 Participants |
| Pediarix Group | Number of Subjects With Serious Adverse Events (SAEs). | 1 Participants |
| Pentacel Group | Number of Subjects With Serious Adverse Events (SAEs). | 7 Participants |
Secondary
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-booster vaccination.
Population: The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 55 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 44 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 85 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 8 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 47 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 4 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 86 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 18 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 59 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 26 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 67 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 20 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 65 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 94 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 35 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 4 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 92 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 4 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 47 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 9 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 44 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 10 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 10 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 41 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 23 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 65 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 9 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 76 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 17 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 61 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 46 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 4 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 68 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 4 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 2 Participants |
Secondary
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 164 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 67 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 11 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 144 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 11 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 147 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 96 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 18 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 161 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 18 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 95 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 28 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 91 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 72 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 6 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 61 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 74 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 172 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 111 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 88 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 34 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 19 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 32 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 169 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 180 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 18 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 35 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 182 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 108 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 78 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 128 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 14 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 120 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 30 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 175 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 30 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 10 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 117 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 39 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 6 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 116 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 168 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 81 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 6 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 22 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 69 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 166 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 21 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 177 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 72 Participants |
Secondary
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3.
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 126 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 23 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 81 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 85 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 46 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 6 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 121 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 6 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 45 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 11 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 44 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 40 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 4 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 35 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 39 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 108 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 58 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 37 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 13 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 5 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 13 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 105 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 129 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 5 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 15 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 135 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 56 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 45 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 58 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 58 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 120 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 7 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 53 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 15 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 52 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 88 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 25 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 9 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 35 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 86 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 9 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 122 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 37 Participants |
Secondary
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2.
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 128 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 31 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 8 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 94 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 7 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 97 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 53 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 6 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 125 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 6 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 56 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 17 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 52 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 47 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 37 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 32 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 132 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 55 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 43 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 13 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 15 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 126 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 143 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 14 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 147 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 51 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 36 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 70 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 61 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 133 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 56 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 15 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 55 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 109 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 39 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 4 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 33 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 108 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 136 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 35 Participants |
Secondary
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1.
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 115 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 36 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 112 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 114 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 42 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 9 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 113 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 9 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 53 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 8 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 48 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 22 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 15 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 31 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 143 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 76 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 56 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 17 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 8 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 13 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 136 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 163 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 17 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 165 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 73 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 34 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 79 Participants |
| Pediarix Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Irritability / Fussiness | 68 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Irritability / Fussiness | 15 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Irritability / Fussiness | 147 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Irritability / Fussiness | 15 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Fever | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Irritability / Fussiness | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Loss of appetite | 80 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Loss of appetite | 26 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Loss of appetite | 4 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Fever | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Loss of appetite | 77 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Drowsiness | 149 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | ≥ G 2 Drowsiness | 53 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Loss of appetite | 4 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G 3 Drowsiness | 12 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Fever | 27 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Rel Drowsiness | 141 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | G3 Rel Drowsiness | 12 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Loss of appetite | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | MA Drowsiness | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Irritability / Fussiness | 153 Participants |
| Pentacel Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 29 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 73 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pediarix/Pentacel | 20 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 94 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pediarix/Pentacel | 127 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Red, Infanrix/Pediarix/Pentacel | 27 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pediarix/Pentacel | 7 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pediarix/Pentacel | 58 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pediarix/Pentacel | 4 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pediarix/Pentacel | 8 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Engerix | 78 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Engerix | 25 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pediarix/Pentacel | 93 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Engerix | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 148 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 70 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pediarix/Pentacel | 27 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pediarix/Pentacel | 26 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pediarix/Pentacel | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 30 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Engerix | 108 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Engerix | 38 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Engerix | 10 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 98 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Red, Infanrix/Pediarix/Pentacel | 32 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pediarix/Pentacel | 151 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pediarix/Pentacel | 9 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 96 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pediarix/Pentacel | 5 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 127 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 62 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 14 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pediarix/Pentacel | 147 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pediarix/Pentacel | 80 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pediarix/Pentacel | 22 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Engerix | 77 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Engerix | 20 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Engerix | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 87 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Red, Infanrix/Pediarix/Pentacel | 37 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Engerix | 64 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Engerix | 18 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Engerix | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 72 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pediarix/Pentacel | 26 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pediarix/Pentacel | 12 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: \> 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pediarix/Pentacel | 67 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pediarix/Pentacel | 18 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 63 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Red, Infanrix/Pediarix/Pentacel | 7 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pediarix/Pentacel | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 43 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pediarix/Pentacel | 7 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pediarix/Pentacel | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pediarix/Pentacel | 10 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 93 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 66 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Engerix | 42 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 41 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 44 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Red, Infanrix/Pediarix/Pentacel | 12 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pediarix/Pentacel | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Engerix | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Engerix | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pediarix/Pentacel | 90 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pediarix/Pentacel | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Engerix | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pediarix/Pentacel | 39 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Engerix | 69 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pediarix/Pentacel | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Engerix | 51 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Engerix | 9 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Engerix | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 56 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Red, Infanrix/Pediarix/Pentacel | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 35 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 75 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 25 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Engerix | 37 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 5 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pediarix/Pentacel | 4 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pediarix/Pentacel | 76 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Engerix | 7 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pediarix/Pentacel | 20 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pediarix/Pentacel | 7 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Engerix | 0 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 41 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Pain,Infanrix/Pediarix/Pentacel | 25 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain,Infanrix/Pediarix/Pentacel | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Swe, Infanrix/Pediarix/Pentacel | 10 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, Infanrix/Pediarix/Pentacel | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 59 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Red,Infanrix/Pediarix/Pentacel | 15 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain,Infanrix/Pediarix/Pentacel | 84 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, Infanrix/Pediarix/Pentacel | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 9 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, ActHIB/Engerix | 40 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, ActHIB/Engerix | 66 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, ActHIB/Engerix | 11 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Pain,Infanrix/Pediarix/Pentacel | 44 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 61 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 104 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, Infanrix/Pediarix/Pentacel | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, ActHIB/Engerix | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, ActHIB/Engerix | 17 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain,Infanrix/Pediarix/Pentacel | 108 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 40 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain,Infanrix/Pediarix/Pentacel | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Red,Infanrix/Pediarix/Pentacel | 12 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Swe, Infanrix/Pediarix/Pentacel | 12 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, Infanrix/Pediarix/Pentacel | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 47 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, ActHIB/Engerix | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 6 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain,Infanrix/Pediarix/Pentacel | 93 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Pain,Infanrix/Pediarix/Pentacel | 31 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain,Infanrix/Pediarix/Pentacel | 6 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, ActHIB/Engerix | 5 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, ActHIB/Engerix | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pediarix/Pentacel | 64 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Red,Infanrix/Pediarix/Pentacel | 15 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, Infanrix/Pediarix/Pentacel | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, ActHIB/Engerix | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pediarix/Pentacel | 42 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥G2 Swe, Infanrix/Pediarix/Pentacel | 7 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, Infanrix/Pediarix/Pentacel | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, ActHIB/Engerix | 0 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, Infanrix hexa/Pediarix/Pentacel | 8 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix hexa/Pediarix/Pentacel | 94 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, Infanrix hexa/Pediarix/Pentacel | 40 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix hexa/Pediarix/Pentacel | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, Infanrix hexa/Pediarix/Pentacel | 47 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, Infanrix hexa/Pediarix/Pentacel | 15 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, Infanrix hexa/Pediarix/Pentacel | 3 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, ActHIB/Engerix | NA Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, Infanrix hexa/Pediarix/Pentacel | 31 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, Infanrix hexa/Pediarix/Pentacel | 10 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, Infanrix hexa/Pediarix/Pentacel | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, Infanrix hexa/Pediarix/Pentacel | 14 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 123 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, Infanrix hexa/Pediarix/Pentacel | 56 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, ActHIB/Engerix | 41 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 66 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, ActHIB/Engerix | 8 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, Infanrix hexa/Pediarix/Pentacel | 35 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 22 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, Infanrix hexa/Pediarix/Pentacel | 15 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, Infanrix hexa/Pediarix/Pentacel | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, ActHIB/Engerix | 19 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, ActHIB/Engerix | 14 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix hexa/Pediarix/Pentacel | 113 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, Infanrix hexa/Pediarix/Pentacel | 4 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, ActHIB/Engerix | 1 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, Infanrix hexa/Pediarix/Pentacel | 65 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, ActHIB/Engerix | 63 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, Infanrix hexa/Pediarix/Pentacel | 17 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, ActHIB/Engerix | 6 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, ActHIB/Engerix | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, ActHIB/Engerix | 55 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, ActHIB/Engerix | 12 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, ActHIB/Engerix | 1 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, Infanrix hexa/Pediarix/Pentacel | 11 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Redness, Infanrix hexa/Pediarix/Pentacel | 57 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Redness, Infanrix hexa/Pediarix/Pentacel | 20 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, Infanrix hexa/Pediarix/Pentacel | 45 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Redness, Infanrix hexa/Pediarix/Pentacel | 3 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swelling, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Redness, Infanrix hexa/Pediarix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Engerix | 100 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Engerix | 45 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling, ActHIB/Engerix | 39 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Engerix | 10 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, Infanrix hexa/Pediarix/Pentacel | 24 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Engerix | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix hexa/Pediarix/Pentacel | 115 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swelling, ActHIB/Engerix | 14 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, Infanrix hexa/Pediarix/Pentacel | 51 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, Infanrix hexa/Pediarix/Pentacel | 12 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swelling, ActHIB/Engerix | 3 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-booster vaccination.
Population: The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pentacel | 42 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Hiberix | 42 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Hiberix | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Hiberix | 61 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Hiberix | 7 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Hiberix | 7 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Hiberix | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Hiberix | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pentacel | 13 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Hiberix | 29 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Hiberix | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Hiberix | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Hiberix | 11 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pentacel | 49 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pentacel | 5 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pentacel | 62 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Red, Infanrix/Pentacel | 17 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Hiberix | 0 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pentacel | 1 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pentacel | 8 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pentacel | 12 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pentacel | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pentacel | 2 Participants |
| Infanrix Hexa Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pentacel | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Hiberix | 29 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Hiberix | 6 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pentacel | 19 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Hiberix | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Hiberix | 64 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Hiberix | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pentacel | 44 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pentacel | 3 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pentacel | 17 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pentacel | 7 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pentacel | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Hiberix | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Hiberix | 49 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Hiberix | 4 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Hiberix | 2 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Hiberix | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Hiberix | 0 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pentacel | 60 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Red, Infanrix/Pentacel | 14 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pentacel | 74 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pentacel | 4 Participants |
| Pediarix Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Hiberix | 15 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Red, Infanrix/Pentacel | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Pain, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Pain, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Pain, Infanrix/Pentacel | 59 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Pain, Infanrix/Pentacel | 16 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Pain, Infanrix/Pentacel | 2 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Pain, Infanrix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Red, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Red, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Red, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Red, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Red, Infanrix/Pentacel | 47 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Red, Infanrix/Pentacel | 13 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Red, Infanrix/Pentacel | 0 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G 2 Swe, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G 3 Swe, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, ActHIB/Hiberix | NA Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | Any Swe, Infanrix/Pentacel | 35 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | ≥ G2 Swe, Infanrix/Pentacel | 14 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | G3 Swe, Infanrix/Pentacel | 4 Participants |
| Pentacel Group | Number of Subjects With Solicited Local Symptoms. | MA Swe, Infanrix/Pentacel | 0 Participants |
Secondary
Number of Subjects With Specific Adverse Events (AEs).
Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Time frame: From Month 0 up to 6 months post primary-vaccination (Month 10)
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Specific Adverse Events (AEs). | 7 Participants |
| Pediarix Group | Number of Subjects With Specific Adverse Events (AEs). | 11 Participants |
| Pentacel Group | Number of Subjects With Specific Adverse Events (AEs). | 10 Participants |
Secondary
Number of Subjects With Specific AEs.
Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Time frame: During the 31-day (Days 0-30) post-booster vaccination.
Population: The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Specific AEs. | 4 Participants |
| Pediarix Group | Number of Subjects With Specific AEs. | 1 Participants |
| Pentacel Group | Number of Subjects With Specific AEs. | 1 Participants |
Secondary
Number of Subjects With Unsolicited AEs.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination.
Population: The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Unsolicited AEs. | 37 Participants |
| Pediarix Group | Number of Subjects With Unsolicited AEs. | 35 Participants |
| Pentacel Group | Number of Subjects With Unsolicited AEs. | 41 Participants |
Secondary
Number of Subjects With Unsolicited AEs.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Time frame: During the 31-day (Days 0-30) post-primary vaccination period.
Population: The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix Hexa Group | Number of Subjects With Unsolicited AEs. | 113 Participants |
| Pediarix Group | Number of Subjects With Unsolicited AEs. | 108 Participants |
| Pentacel Group | Number of Subjects With Unsolicited AEs. | 96 Participants |