Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis, Tetanus
Conditions
Keywords
Infanrix-IPV+Hib
Brief summary
The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.
Interventions
BIOLOGICALInfanrix-IPV/Hib™
Intramuscular, three doses
BIOLOGICALInfanrix Hib™
Intramuscular, three doses
BIOLOGICALPoliorix™
Intramuscular, three doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit. * Born after a gestation period of 36 to 42 weeks, inclusive. * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s) or LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Child in care. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B 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/or Haemophilus influenzae type b (Hib) disease or vaccination. * History of seizures or progressive neurological disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | One month after the third vaccine dose (Month 3 or Month 4) | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen | One month after the third vaccine dose (Month 3 or Month 4) | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL). |
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | One month after the third vaccine dose (Month 3 or Month 4) | A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8. |
| Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | One month after the third vaccine dose (Month 3 or Month 4) | Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects \[antibody concentration lower than (\<) 5 EL.U/mL\], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination. |
| Anti-D and Anti-T Antibody Concentrations | Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Month 0 to Month 4/5) | 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 Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period after any dose | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Anti-PRP Antibody Concentrations | Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. |
| Anti-polio Types 1, 2 and 3 Antibody Titers | Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) | Antibody titers were presented as geometric mean titers (GMTs). |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. |
Countries
China
Participant flow
Recruitment details
Out of the 985 subjects originally enrolled in the study, 984 subjects were vaccinated with at least one dose of the study vaccine.
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Infanrix-IPV+Hib 1 Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. | 330 |
| Infanrix-IPV+Hib 2 Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. | 324 |
| Infanrix-Hib+Poliorix Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. | 330 |
| Total | 984 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse event, fatal | 1 | 1 | 0 |
| Overall Study | Adverse event, non-fatal | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Migrated/moved from study area | 2 | 0 | 4 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 3 |
Baseline characteristics
| Characteristic | Infanrix-IPV+Hib 1 Group | Infanrix-IPV+Hib 2 Group | Infanrix-Hib+Poliorix Group | Total |
|---|---|---|---|---|
| Age, Continuous | 9.9 Weeks STANDARD_DEVIATION 1.12 | 14.3 Weeks STANDARD_DEVIATION 1.14 | 9.9 Weeks STANDARD_DEVIATION 1.17 | 11.35 Weeks STANDARD_DEVIATION 2.36 |
| Race/Ethnicity, Customized Asian-Chinese heritage | 330 Participants | 324 Participants | 330 Participants | 984 Participants |
| Sex: Female, Male Female | 155 Participants | 147 Participants | 141 Participants | 443 Participants |
| Sex: Female, Male Male | 175 Participants | 177 Participants | 189 Participants | 541 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 330 | 0 / 324 | 0 / 330 |
| other Total, other adverse events | 279 / 330 | 277 / 324 | 272 / 330 |
| serious Total, serious adverse events | 6 / 330 | 3 / 324 | 4 / 330 |
Outcome results
Primary
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 146 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 147 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 156 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 156 Participants |
| Infanrix-Hib+Poliorix Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 147 Participants |
| Infanrix-Hib+Poliorix Group | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 147 Participants |
Comparison: To demonstrate that the immunogenicity of Infanrix™ -IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-D, one month after the third vaccine dose.95% CI: [-1.88, 3.76]
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-T, one month after the third vaccine dose.95% CI: [-2.56, 2.56]
Primary
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens
A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 2 | 147 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 1 | 147 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 3 | 147 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 2 | 157 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 1 | 157 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 3 | 157 Participants |
| Infanrix-Hib+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 1 | 150 Participants |
| Infanrix-Hib+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 3 | 150 Participants |
| Infanrix-Hib+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | Anti-polio 2 | 150 Participants |
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 1 antibodies, one month after the third vaccine dose.95% CI: [-2.51, 2.56]
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose.95% CI: [-2.51, 2.56]
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose.95% CI: [-2.51, 2.56]
Primary
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infanrix-IPV+Hib 1 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen | 142 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen | 155 Participants |
| Infanrix-Hib+Poliorix Group | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen | 133 Participants |
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRP antibodies, one month after the third vaccine dose.95% CI: [-14.44, -2.13]
Primary
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects \[antibody concentration lower than (\<) 5 EL.U/mL\], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 147 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 147 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 145 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 155 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 155 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 156 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PT | 147 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-PRN | 145 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Anti-FHA | 144 Participants |
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PT antigens, one month after the third vaccine dose.95% CI: [-3.74, 1.89]
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose.95% CI: [-6.75, -0.11]
Comparison: To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose.95% CI: [-4.6, 3.04]
Secondary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time frame: Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.052 IU/mL |
| Infanrix-IPV+Hib 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M3/M4 | 4.118 IU/mL |
| Infanrix-IPV+Hib 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.051 IU/mL |
| Infanrix-IPV+Hib 1 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M3/M4 | 0.719 IU/mL |
| Infanrix-IPV+Hib 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.052 IU/mL |
| Infanrix-IPV+Hib 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M3/M4 | 0.753 IU/mL |
| Infanrix-IPV+Hib 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M3/M4 | 4.124 IU/mL |
| Infanrix-IPV+Hib 2 Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.051 IU/mL |
| Infanrix-Hib+Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M3/M4 | 3.618 IU/mL |
| Infanrix-Hib+Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.051 IU/mL |
| Infanrix-Hib+Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M3/M4 | 0.613 IU/mL |
| Infanrix-Hib+Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.05 IU/mL |
Secondary
Anti-polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1, M0 | 9.4 Titers |
| Infanrix-IPV+Hib 1 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1, M3/M4 | 1143.7 Titers |
| Infanrix-IPV+Hib 1 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2, M0 | 6.3 Titers |
| Infanrix-IPV+Hib 1 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2, M3/M4 | 416.2 Titers |
| Infanrix-IPV+Hib 1 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3, M0 | 5.8 Titers |
| Infanrix-IPV+Hib 1 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3, M3/M4 | 1478.8 Titers |
| Infanrix-IPV+Hib 2 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3, M3/M4 | 1411.6 Titers |
| Infanrix-IPV+Hib 2 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1, M0 | 7.1 Titers |
| Infanrix-IPV+Hib 2 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2, M3/M4 | 458.6 Titers |
| Infanrix-IPV+Hib 2 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3, M0 | 4.9 Titers |
| Infanrix-IPV+Hib 2 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1, M3/M4 | 1328.9 Titers |
| Infanrix-IPV+Hib 2 Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2, M0 | 5 Titers |
| Infanrix-Hib+Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1, M3/M4 | 533.6 Titers |
| Infanrix-Hib+Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2, M0 | 6.9 Titers |
| Infanrix-Hib+Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3, M3/M4 | 820.7 Titers |
| Infanrix-Hib+Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2, M3/M4 | 186.4 Titers |
| Infanrix-Hib+Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1, M0 | 9.2 Titers |
| Infanrix-Hib+Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3, M0 | 5.7 Titers |
Secondary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time frame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.127 µg/mL |
| Infanrix-IPV+Hib 1 Group | Anti-PRP Antibody Concentrations | Anti-PRP, M3/M4 | 5.601 µg/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.135 µg/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PRP Antibody Concentrations | Anti-PRP, M3/M4 | 9.396 µg/mL |
| Infanrix-Hib+Poliorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.15 µg/mL |
| Infanrix-Hib+Poliorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M3/M4 | 2.826 µg/mL |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 2.9 EL.U/mL |
| Infanrix-IPV+Hib 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M3/M4 | 108.7 EL.U/mL |
| Infanrix-IPV+Hib 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 2.9 EL.U/mL |
| Infanrix-IPV+Hib 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M3/M4 | 87.7 EL.U/mL |
| Infanrix-IPV+Hib 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 2.6 EL.U/mL |
| Infanrix-IPV+Hib 1 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M3/M4 | 44.8 EL.U/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M3/M4 | 43.7 EL.U/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 2.7 EL.U/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M3/M4 | 87.6 EL.U/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 2.6 EL.U/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M3/M4 | 114.7 EL.U/mL |
| Infanrix-IPV+Hib 2 Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 2.6 EL.U/mL |
| Infanrix-Hib+Poliorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M3/M4 | 97.1 EL.U/mL |
| Infanrix-Hib+Poliorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 2.9 EL.U/mL |
| Infanrix-Hib+Poliorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M3/M4 | 43.2 EL.U/mL |
| Infanrix-Hib+Poliorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M3/M4 | 76.3 EL.U/mL |
| Infanrix-Hib+Poliorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 2.8 EL.U/mL |
| Infanrix-Hib+Poliorix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 2.5 EL.U/mL |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2 | 53 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1 | 123 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 1 | 77 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 1 | 137 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1 | 95 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2 | 96 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 2 | 69 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 2 | 131 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3 | 43 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3 | 77 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 3 | 65 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 3 | 93 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across doses | 124 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across doses | 171 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Across doses | 131 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Across doses | 217 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2 | 100 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 2 | 72 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 2 | 144 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across doses | 166 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3 | 32 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3 | 70 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Across doses | 217 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 3 | 57 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1 | 80 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Across doses | 136 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1 | 120 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 3 | 82 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 1 | 86 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 1 | 152 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2 | 47 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across doses | 102 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 3 | 36 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 2 | 103 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Across doses | 99 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 1 | 76 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Dose 2 | 59 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Across doses | 183 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 1 | 69 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 2 | 102 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 3 | 75 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 2 | 53 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness, Dose 3 | 28 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Across doses | 163 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 1 | 116 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability, Dose 3 | 61 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever/Axillary, Dose 1 | 103 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite, Across doses | 114 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Across doses | 14 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 1 | 8 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 1 | 16 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 3 | 5 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 2 | 43 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Across doses | 28 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 3 | 10 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 2 | 14 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Across doses | 90 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 1 | 65 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 2 | 6 Participants |
| Infanrix-IPV+Hib 1 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 3 | 39 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 3 | 41 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 3 | 11 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 3 | 8 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 1 | 19 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Across doses | 91 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 1 | 9 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Across doses | 17 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 2 | 50 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Across doses | 34 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 2 | 19 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 1 | 64 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 2 | 58 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Across doses | 26 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Across doses | 19 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 1 | 83 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 1 | 15 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 1 | 9 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Across doses | 102 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 2 | 13 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain, Dose 3 | 39 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness, Dose 3 | 8 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling, Dose 3 | 6 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Month 0 to Month 4/5)
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 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) post-vaccination period after any dose
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 1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 98 Participants |
| Infanrix-IPV+Hib 2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 114 Participants |
| Infanrix-Hib+Poliorix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 110 Participants |