Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
Conditions
Keywords
Primary vaccination, combination vaccine, South Korea
Brief summary
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
Interventions
BIOLOGICALInfanrix™-IPV+Hib
Intramuscular, 3 doses
BIOLOGICALInfanrix™ IPV
Intramuscular, 3 doses
BIOLOGICALHiberix™
Intramuscular, 3 doses
BIOLOGICALSynflorix™
Intramuscular, 3 doses
BIOLOGICALRotarix™
Oral, 2 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 69 Days
Healthy volunteers
Yes
Inclusion criteria
* A male or female between, and including, 42 and 69 days of age at the time of the first vaccination. * Born after a gestation period of 37 to 42 weeks inclusive. * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine. * 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. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Acute disease and/or fever at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | At Month 5 | A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL). |
| Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | At Month 5 | A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects. |
| Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. | At Month 5 | A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. | At Month 5 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations for Anti-D and Anti-T Antibodies. | At Month 0 and Month 5 | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL. |
| Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | At Month 0 | A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects. |
| Titres for Anti-polio Types 1, 2 and 3. | At Month 0 and Month 5 | Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8. |
| Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. | At Month 0 | A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL). |
| Number of Subjects With Any Serious Adverse Events (SAEs). | During the entire study period (from Month 0 to Month 7) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. | At Month 5 | Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects. |
| Number of Subjects With Any Solicited Local Symptoms. | During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™ | Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms. | During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™ | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever \[defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs). | During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™ | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. |
| Concentrations of Anti-PRP Antibodies. | At Month 0 and Month 5 | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL. |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | At Month 0 and Month 5 | A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL). |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | At Month 0 | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL. |
| Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | At Month 0 | A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL). |
Countries
South Korea
Participant flow
Pre-assignment details
Initially, a total of 454 subjects were enrolled in the study but 3 subjects had withdrawn from the study. Therefore, a total of 451 subjects were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Infanrix-IPV+Hib Group Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally. | 224 |
| Infanrix IPV Group Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally. | 227 |
| Total | 451 |
Baseline characteristics
| Characteristic | Infanrix IPV Group | Total | Infanrix-IPV+Hib Group |
|---|---|---|---|
| Age, Continuous | 8.8 weeks STANDARD_DEVIATION 1.09 | 8.8 weeks STANDARD_DEVIATION 1.09 | 8.8 weeks STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 226 Participants | 450 Participants | 224 Participants |
| Race/Ethnicity, Customized Not specified | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 115 Participants | 212 Participants | 97 Participants |
| Sex: Female, Male Male | 112 Participants | 239 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 224 | 0 / 227 |
| other Total, other adverse events | 218 / 224 | 220 / 227 |
| serious Total, serious adverse events | 25 / 224 | 21 / 227 |
Outcome results
Primary
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: At Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. | Anti-PT | 54.2 EL.U/mL |
| Infanrix-IPV+Hib Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. | Anti-FHA | 125 EL.U/mL |
| Infanrix-IPV+Hib Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. | Anti-PRN | 125.8 EL.U/mL |
| Infanrix IPV Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. | Anti-PT | 56 EL.U/mL |
| Infanrix IPV Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. | Anti-FHA | 134.2 EL.U/mL |
| Infanrix IPV Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. | Anti-PRN | 133.4 EL.U/mL |
Primary
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Time frame: At Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-D | 213 Participants |
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-T | 213 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-D | 217 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-T | 217 Participants |
Primary
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
Time frame: At Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 1 | 212 Participants |
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 2 | 204 Participants |
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 3 | 197 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 1 | 216 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 2 | 211 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 3 | 197 Participants |
Primary
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: At Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. | 213 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. | 217 Participants |
Secondary
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.
Time frame: At Month 0
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PT | 3.0 EL.U/mL |
| Infanrix-IPV+Hib Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-FHA | 10.5 EL.U/mL |
| Infanrix-IPV+Hib Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PRN | 2.9 EL.U/mL |
| Infanrix IPV Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PT | 3.1 EL.U/mL |
| Infanrix IPV Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-FHA | 11.7 EL.U/mL |
| Infanrix IPV Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PRN | 3.1 EL.U/mL |
Secondary
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time frame: At Month 0 and Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-D at Month 0 | 0.058 IU/mL |
| Infanrix-IPV+Hib Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-D at Month 5 | 8.096 IU/mL |
| Infanrix-IPV+Hib Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-T at Month 0 | 0.081 IU/mL |
| Infanrix-IPV+Hib Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-T at Month 5 | 10.259 IU/mL |
| Infanrix IPV Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-T at Month 5 | 12.421 IU/mL |
| Infanrix IPV Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-D at Month 0 | 0.060 IU/mL |
| Infanrix IPV Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-T at Month 0 | 0.091 IU/mL |
| Infanrix IPV Group | Concentrations for Anti-D and Anti-T Antibodies. | Anti-D at Month 5 | 8.692 IU/mL |
Secondary
Concentrations of Anti-PRP Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.
Time frame: At Month 0 and Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Concentrations of Anti-PRP Antibodies. | Anti-PRP at Month 0 | 0.165 µg/mL |
| Infanrix-IPV+Hib Group | Concentrations of Anti-PRP Antibodies. | Anti-PRP at Month 5 | 8.456 µg/mL |
| Infanrix IPV Group | Concentrations of Anti-PRP Antibodies. | Anti-PRP at Month 0 | 0.219 µg/mL |
| Infanrix IPV Group | Concentrations of Anti-PRP Antibodies. | Anti-PRP at Month 5 | 18.700 µg/mL |
Secondary
Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).
Time frame: At Month 0 and Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PT at Month 5 | 213 Participants |
| Infanrix-IPV+Hib Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-FHA at Month 5 | 213 Participants |
| Infanrix-IPV+Hib Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PRN at Month 5 | 213 Participants |
| Infanrix-IPV+Hib Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PT at Month 0 | 27 Participants |
| Infanrix-IPV+Hib Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-FHA at Month 0 | 170 Participants |
| Infanrix-IPV+Hib Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PRN at Month 0 | 25 Participants |
| Infanrix IPV Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-FHA at Month 0 | 178 Participants |
| Infanrix IPV Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PT at Month 5 | 217 Participants |
| Infanrix IPV Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PT at Month 0 | 34 Participants |
| Infanrix IPV Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-FHA at Month 5 | 217 Participants |
| Infanrix IPV Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PRN at Month 0 | 30 Participants |
| Infanrix IPV Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). | Anti-PRN at Month 5 | 217 Participants |
Secondary
Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
Time frame: At Month 0
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 1 | 104 Participants |
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 2 | 119 Participants |
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 3 | 41 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 1 | 89 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-Polio 2 | 108 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. | Anti-polio 3 | 31 Participants |
Secondary
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Time frame: At Month 0
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-D | 29 Participants |
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-T | 64 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-D | 30 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. | Anti-T | 76 Participants |
Secondary
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: At Month 0
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. | 91 Participants |
| Infanrix IPV Group | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. | 109 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Month 0 to Month 7)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 25 Participants |
| Infanrix IPV Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 21 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever \[defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)\]. Any = incidence of a particular symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects With Any Solicited General Symptoms. | Any Drowsiness | 153 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects With Any Solicited General Symptoms. | Any Irritability/Fussiness | 181 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects With Any Solicited General Symptoms. | Any Loss of appetite | 120 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects With Any Solicited General Symptoms. | Temperature ≥ 37.5°C | 83 Participants |
| Infanrix IPV Group | Number of Subjects With Any Solicited General Symptoms. | Temperature ≥ 37.5°C | 81 Participants |
| Infanrix IPV Group | Number of Subjects With Any Solicited General Symptoms. | Any Drowsiness | 147 Participants |
| Infanrix IPV Group | Number of Subjects With Any Solicited General Symptoms. | Any Loss of appetite | 103 Participants |
| Infanrix IPV Group | Number of Subjects With Any Solicited General Symptoms. | Any Irritability/Fussiness | 182 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects With Any Solicited Local Symptoms. | Any Pain | 143 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects With Any Solicited Local Symptoms. | Any Redness | 177 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects With Any Solicited Local Symptoms. | Any Swelling | 130 Participants |
| Infanrix IPV Group | Number of Subjects With Any Solicited Local Symptoms. | Any Pain | 146 Participants |
| Infanrix IPV Group | Number of Subjects With Any Solicited Local Symptoms. | Any Redness | 167 Participants |
| Infanrix IPV Group | Number of Subjects With Any Solicited Local Symptoms. | Any Swelling | 121 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination.
Time frame: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 130 Participants |
| Infanrix IPV Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 123 Participants |
Secondary
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.
Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.
Time frame: At Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 211 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 207 Participants |
| Infanrix-IPV+Hib Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 213 Participants |
| Infanrix IPV Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 215 Participants |
| Infanrix IPV Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 207 Participants |
| Infanrix IPV Group | Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 216 Participants |
Secondary
Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: At Month 0 and Month 5
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 at Month 0 | 9.5 titers |
| Infanrix-IPV+Hib Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 at Month 5 | 328.8 titers |
| Infanrix-IPV+Hib Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 at Month 0 | 10.8 titers |
| Infanrix-IPV+Hib Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 at Month 5 | 340.6 titers |
| Infanrix-IPV+Hib Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 at Month 0 | 5.5 titers |
| Infanrix-IPV+Hib Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 at Month 5 | 377.7 titers |
| Infanrix IPV Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 at Month 0 | 4.9 titers |
| Infanrix IPV Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 at Month 0 | 9.4 titers |
| Infanrix IPV Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 at Month 5 | 400.2 titers |
| Infanrix IPV Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 1 at Month 5 | 372.7 titers |
| Infanrix IPV Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 3 at Month 5 | 465.3 titers |
| Infanrix IPV Group | Titres for Anti-polio Types 1, 2 and 3. | Anti-polio 2 at Month 0 | 8.8 titers |