Acellular Pertussis, Diphtheria, Tetanus
Conditions
Keywords
Infanrix/Hib, Chinese children
Brief summary
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Subjects should have completed the full three-dose primary vaccination course in study 104567. * A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding booster vaccination, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. * 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 measles or combined measles, mumps and rubella (MMR) vaccination. * 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. * Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases since the end of the primary study. * History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * 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 progressive neurological disorders or seizures. * Acute disease and/or fever at time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period. * Occurrence of any of the following adverse events (AEs) after previous administration of a diphtheria-tetanus-pertussis (DTP) vaccine: * Hypersensitivity reaction due to any component of the vaccine. * Encephalopathy. * Fever ≥ 40.0 °C (axillary temperature) within 48 hours of vaccination. * Collapse or shock-like state within 48 hours of vaccination. * Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours. * Seizures with or without fever occurring within 3 days of vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations | One month after booster vaccination | Geometric mean concentrations are given in microgram per milliliter (μg/mL). |
| Anti-diphtheria Toxoid Antibody Concentrations | One month after booster vaccination | Geometric mean concentrations are given in international Unit per milliliter (IU/mL). |
| Anti-tetanus Toxoid Antibody Concentrations | One month after booster vaccination | Geometric mean concentrations are given in IU/mL. |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | One month after booster vaccination | Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL). |
| The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | One month after booster vaccination | Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Local and General Symptoms | During the 4-day follow-up period after booster vaccination | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite. |
| Anti-PRP Antibody Concentrations | Before booster vaccination | Geometric mean concentrations are given in μg/mL. |
| Number of Subjects Reporting Serious Adverse Events (SAE) | During the 31-day follow-up period after booster vaccination | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | During the 31-day follow-up period after booster vaccination | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Anti-diphtheria Toxoid Antibody Concentrations | Before booster vaccination | Geometric mean concentrations are given in IU/mL. |
| Anti-tetanus Toxoid Antibody Concentrations | Before booster vaccination | Geometric mean concentrations are given in IU/mL. |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Before booster vaccination | Geometric mean concentrations are given in EL.U/mL. |
| The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Before booster vaccination | Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infanrix/Hib Single Injection Group Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix. | 244 |
| Infanrix + Hiberix Separate Injection Group Subjects received two separate injections, one of Infanrix and one of Hiberix. | 223 |
| Total | 467 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 5 |
Baseline characteristics
| Characteristic | Infanrix + Hiberix Separate Injection Group | Total | Infanrix/Hib Single Injection Group |
|---|---|---|---|
| Age, Continuous | 19.2 months STANDARD_DEVIATION 0.75 | 19.2 months STANDARD_DEVIATION 0.77 | 19.2 months STANDARD_DEVIATION 0.79 |
| Sex: Female, Male Female | 111 Participants | 224 Participants | 113 Participants |
| Sex: Female, Male Male | 112 Participants | 243 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 133 / 244 | 127 / 223 |
| serious Total, serious adverse events | 1 / — | 3 / — |
Outcome results
Primary
Anti-diphtheria Toxoid Antibody Concentrations
Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
Time frame: One month after booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-diphtheria Toxoid Antibody Concentrations | 0.945 IU/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-diphtheria Toxoid Antibody Concentrations | 0.926 IU/mL |
Primary
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Time frame: One month after booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PT | 52.2 EL.U/mL |
| Infanrix/Hib Single Injection Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-FHA | 93.3 EL.U/mL |
| Infanrix/Hib Single Injection Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PRN | 235.9 EL.U/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PT | 55.8 EL.U/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-FHA | 92.8 EL.U/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PRN | 241.6 EL.U/mL |
Primary
Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations
Geometric mean concentrations are given in microgram per milliliter (μg/mL).
Time frame: One month after booster vaccination
Population: Analysis was performed on the According To Protocol (ATP) cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations | 34.428 μg/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations | 132.075 μg/mL |
Primary
Anti-tetanus Toxoid Antibody Concentrations
Geometric mean concentrations are given in IU/mL.
Time frame: One month after booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-tetanus Toxoid Antibody Concentrations | 7.455 IU/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-tetanus Toxoid Antibody Concentrations | 10.104 IU/mL |
Primary
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
Time frame: One month after booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against PRP (n=238, 216) | 238 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against diphtheria (n=237, 214) | 237 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against tetanus (n=237, 214) | 237 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PT (n=239, 216) | 226 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-FHA (n=239, 216) | 238 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PRN (n=239, 216) | 239 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-FHA (n=239, 216) | 216 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against PRP (n=238, 216) | 216 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PT (n=239, 216) | 213 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against diphtheria (n=237, 214) | 214 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PRN (n=239, 216) | 215 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against tetanus (n=237, 214) | 214 subjects |
Secondary
Anti-diphtheria Toxoid Antibody Concentrations
Geometric mean concentrations are given in IU/mL.
Time frame: Before booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-diphtheria Toxoid Antibody Concentrations | 0.055 IU/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-diphtheria Toxoid Antibody Concentrations | 0.054 IU/mL |
Secondary
Anti-PRP Antibody Concentrations
Geometric mean concentrations are given in μg/mL.
Time frame: Before booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-PRP Antibody Concentrations | 1.240 μg/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-PRP Antibody Concentrations | 2.461 μg/mL |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Geometric mean concentrations are given in EL.U/mL.
Time frame: Before booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 10.1 EL.U/mL |
| Infanrix/Hib Single Injection Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 10.2 EL.U/mL |
| Infanrix/Hib Single Injection Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 10.0 EL.U/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 10.0 EL.U/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 10.3 EL.U/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 10.3 EL.U/mL |
Secondary
Anti-tetanus Toxoid Antibody Concentrations
Geometric mean concentrations are given in IU/mL.
Time frame: Before booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Anti-tetanus Toxoid Antibody Concentrations | 0.219 IU/mL |
| Infanrix + Hiberix Separate Injection Group | Anti-tetanus Toxoid Antibody Concentrations | 0.311 IU/mL |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the 31-day follow-up period after booster vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 1 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 3 subjects |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
Time frame: During the 4-day follow-up period after booster vaccination
Population: Analysis was performed on subjects from the Total Vaccinated Cohort with a documented dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 9 subjects |
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 73 subjects |
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 16 subjects |
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability | 43 subjects |
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness | 26 subjects |
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite | 40 subjects |
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 26 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite | 39 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 26 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 8 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 1 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness | 20 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 93 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability | 46 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 31-day follow-up period after booster vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix/Hib Single Injection Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 66 subjects |
| Infanrix + Hiberix Separate Injection Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 56 subjects |
Secondary
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
Time frame: Before booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against PRP (n= 237, 216) | 236 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against diphtheria (n= 237, 214) | 21 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against tetanus (n= 237, 214) | 209 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PT (n= 239, 216) | 0 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-FHA (n= 239, 216) | 2 subjects |
| Infanrix/Hib Single Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PRN (n= 239, 216) | 3 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-FHA (n= 239, 216) | 3 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against PRP (n= 237, 216) | 216 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PT (n= 239, 216) | 1 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against diphtheria (n= 237, 214) | 16 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seropositivity for anti-PRN (n= 239, 216) | 4 subjects |
| Infanrix + Hiberix Separate Injection Group | The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Seroprotection against tetanus (n= 237, 214) | 198 subjects |