Tetanus, Acellular Pertussis, Diphtheria
Conditions
Brief summary
DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Participants in this Phase IIIb study will either receive GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or co-administration of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis (DTPa) vaccine and Sanofi-Pasteurs' inactivated poliovirus vaccine. Vaccines for both groups will be administered at 2, 4 and 6 months of age. Two blood samples will be collected during the course of the study: prior to vaccination and one month after the third vaccine dose.
Interventions
BIOLOGICALDTPa-IPV
3 intramuscular injections
BIOLOGICALDTPa
3 intramuscular injections
BIOLOGICALIMOVAX Polio®
3 intramuscular injections
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol . * A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after a gestation period of 36 to 42 weeks inclusive.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine. * Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose. * 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). * Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease. * History of diphtheria, tetanus, pertussis and/or poliovirus diseases. * Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period. * Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | One month (Month 5) post-primary vaccination course | A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL). |
| Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 | One month (Month 5) post-primary vaccination course | A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8. |
| Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) | One month (Month 5) post-primary vaccination course | Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose. |
| Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens | One month (Month 5) post-primary vaccination course | Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations \< 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period, across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects Reporting Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period, across doses | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination. |
| Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Before (Pre) and one month after (Post) the primary vaccination course | A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL). |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | During the entire study period (from Month 0 up to Month 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 Reporting Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period | 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. |
| Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Before (Pre) and one month after (Post) the primary vaccination course | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL). |
| Titers for Poliovirus Type 1, 2 and 3 Antibodies | Before (Pre) and one month after (Post) the primary vaccination course | Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8. |
| Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Before (Pre) and one month after (Post) the primary vaccination course | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL). |
Countries
South Korea
Participant flow
Pre-assignment details
Of the 458 subjects enrolled in the study, 6 subjects (5 from Infanrix-IPV Group and 1 from Infanrix + IMOVAX Polio Group) were not administered the study vaccine due to consent withdrawal from parents/guardians and received an elimination code.
Participants by arm
| Arm | Count |
|---|---|
| Infanrix-IPV Group Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh. | 224 |
| Infanrix + IMOVAX Polio Group Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs. | 228 |
| Total | 452 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | Infanrix-IPV Group | Infanrix + IMOVAX Polio Group | Total |
|---|---|---|---|
| Age, Continuous | 8.8 Weeks STANDARD_DEVIATION 0.9 | 8.8 Weeks STANDARD_DEVIATION 0.91 | 8.8 Weeks STANDARD_DEVIATION 0.63 |
| Sex: Female, Male Female | 112 Participants | 110 Participants | 222 Participants |
| Sex: Female, Male Male | 112 Participants | 118 Participants | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 200 / 224 | 196 / 228 |
| serious Total, serious adverse events | 15 / 224 | 17 / 228 |
Outcome results
Primary
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).
Time frame: One month (Month 5) post-primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-D | 204 Subjects |
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-T | 204 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-D | 211 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-T | 211 Subjects |
Comparison: Non-inferiority in terms of vaccine response to diphteria95% CI: [-1.85, 1.79]
Comparison: Non-inferiority in terms of vaccine response to tetanus95% CI: [-1.85, 1.79]
Primary
Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.
Time frame: One month (Month 5) post-primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio 1 (N=204; 207) | 204 Subjects |
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio 2 (N=204; 205) | 204 Subjects |
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio 3 (N=204; 207) | 203 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio 1 (N=204; 207) | 207 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio 2 (N=204; 205) | 204 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 | Anti-polio 3 (N=204; 207) | 206 Subjects |
Comparison: Immune response non-inferiority - Anti-Polio 195% CI: [-1.85, 1.82]
Comparison: Immune response non-inferiority - Anti-Polio 295% CI: [-1.36, 2.71]
Comparison: Immune response non-inferiority - Anti-Polio 395% CI: [-2.28, 2.24]
Primary
Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)
Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.
Time frame: One month (Month 5) post-primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV Group | Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) | Anti-PT | 200 Subjects |
| Infanrix-IPV Group | Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) | Anti-FHA | 201 Subjects |
| Infanrix-IPV Group | Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) | Anti-PRN | 202 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) | Anti-PT | 206 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) | Anti-FHA | 209 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) | Anti-PRN | 210 Subjects |
Comparison: Immune response non-inferiority - Anti-PT95% CI: [-0.46, 4.13]
Comparison: Immune response non-inferiority - Anti-FHA95% CI: [-1.88, 2.95]
Comparison: Immune response non-inferiority - Anti-PRN95% CI: [-1.4, 2.64]
Primary
Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens
Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations \< 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).
Time frame: One month (Month 5) post-primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV Group | Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens | Anti-PT (N=200; 209) | 200 Subjects |
| Infanrix-IPV Group | Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens | Anti-FHA (N=202; 211) | 201 Subjects |
| Infanrix-IPV Group | Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens | Anti-PRN (N=202; 211) | 202 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens | Anti-PT (N=200; 209) | 206 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens | Anti-FHA (N=202; 211) | 209 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens | Anti-PRN (N=202; 211) | 210 Subjects |
Secondary
Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL).
Time frame: Before (Pre) and one month after (Post) the primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-D, PRE (N=202; 212) | 0.052 IU/mL |
| Infanrix-IPV Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-D, POST (N=204; 211) | 4.333 IU/mL |
| Infanrix-IPV Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-T, PRE (N=202; 212) | 0.059 IU/mL |
| Infanrix-IPV Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-T, POST (N=204; 211) | 10.306 IU/mL |
| Infanrix + IMOVAX Polio Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-T, POST (N=204; 211) | 7.139 IU/mL |
| Infanrix + IMOVAX Polio Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-D, PRE (N=202; 212) | 0.053 IU/mL |
| Infanrix + IMOVAX Polio Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-T, PRE (N=202; 212) | 0.06 IU/mL |
| Infanrix + IMOVAX Polio Group | Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) | Anti-D, POST (N=204; 211) | 2.63 IU/mL |
Secondary
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Time frame: Before (Pre) and one month after (Post) the primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PT, PRE (N=200; 210) | 3 EL.U/mL |
| Infanrix-IPV Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PT, POST (N=204; 211) | 63.3 EL.U/mL |
| Infanrix-IPV Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-FHA, PRE (N=202; 212) | 7.4 EL.U/mL |
| Infanrix-IPV Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-FHA, POST (N=204; 211) | 294.3 EL.U/mL |
| Infanrix-IPV Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PRN, PRE (N=202; 212) | 2.7 EL.U/mL |
| Infanrix-IPV Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PRN, POST (N=204; 211) | 205 EL.U/mL |
| Infanrix + IMOVAX Polio Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PRN, PRE (N=202; 212) | 2.7 EL.U/mL |
| Infanrix + IMOVAX Polio Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PT, PRE (N=200; 210) | 3.2 EL.U/mL |
| Infanrix + IMOVAX Polio Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-FHA, POST (N=204; 211) | 259.6 EL.U/mL |
| Infanrix + IMOVAX Polio Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PT, POST (N=204; 211) | 55.6 EL.U/mL |
| Infanrix + IMOVAX Polio Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-PRN, POST (N=204; 211) | 155.6 EL.U/mL |
| Infanrix + IMOVAX Polio Group | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) | Anti-FHA, PRE (N=202; 212) | 8.5 EL.U/mL |
Secondary
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL).
Time frame: Before (Pre) and one month after (Post) the primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-D, PRE (N=202; 212) | 0 Subjects |
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-D, POST (N=204; 211) | 194 Subjects |
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-T, PRE (N=202; 212) | 1 Subjects |
| Infanrix-IPV Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-T, POST (N=204; 211) | 204 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-T, POST (N=204; 211) | 208 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-D, PRE (N=202; 212) | 0 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-T, PRE (N=202; 212) | 1 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) | Anti-D, POST (N=204; 211) | 187 Subjects |
Secondary
Number of Subjects Reporting 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 up to Month 5)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix-IPV Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 15 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 17 Subjects |
Secondary
Number of Subjects Reporting Any 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
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix-IPV Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 135 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 138 Subjects |
Secondary
Number of Subjects Reporting Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period, across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Drowsiness | 95 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Drowsiness | 4 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Drowsiness | 54 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever (axillary) | 63 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever (axillary) | 4 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever (axillary) | 45 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Irritability | 140 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade Irritability | 14 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Irritability | 85 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Loss of appetite | 84 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Loss of appetite | 1 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Loss of appetite | 50 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Loss of appetite | 0 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Any Drowsiness | 99 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Any Irritability | 139 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Drowsiness | 2 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Any Loss of appetite | 78 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Related Drowsiness | 53 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Grade Irritability | 10 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever (axillary) | 38 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Related Loss of appetite | 46 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever (axillary) | 1 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Related Irritability | 91 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever (axillary) | 22 Subjects |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period, across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix-IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain | 92 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain | 5 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness | 115 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness | 22 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling | 74 Subjects |
| Infanrix-IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling | 17 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling | 79 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain | 96 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness | 26 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain | 8 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling | 20 Subjects |
| Infanrix + IMOVAX Polio Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness | 116 Subjects |
Secondary
Titers for Poliovirus Type 1, 2 and 3 Antibodies
Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8.
Time frame: Before (Pre) and one month after (Post) the primary vaccination course
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix-IPV Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 1, PRE (N=199; 212) | 6.3 Titers |
| Infanrix-IPV Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 1, POST (N=204; 207) | 755.7 Titers |
| Infanrix-IPV Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 2, PRE (N=202; 211) | 5.8 Titers |
| Infanrix-IPV Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 2, POST (N=204; 205) | 704.7 Titers |
| Infanrix-IPV Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 3, PRE (N=202; 212) | 5 Titers |
| Infanrix-IPV Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 3, POST (N=204; 207) | 1209.5 Titers |
| Infanrix + IMOVAX Polio Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 3, PRE (N=202; 212) | 4.9 Titers |
| Infanrix + IMOVAX Polio Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 1, PRE (N=199; 212) | 6.1 Titers |
| Infanrix + IMOVAX Polio Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 2, POST (N=204; 205) | 267.6 Titers |
| Infanrix + IMOVAX Polio Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 1, POST (N=204; 207) | 263 Titers |
| Infanrix + IMOVAX Polio Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 3, POST (N=204; 207) | 438.3 Titers |
| Infanrix + IMOVAX Polio Group | Titers for Poliovirus Type 1, 2 and 3 Antibodies | Anti-polio 2, PRE (N=202; 211) | 6.5 Titers |