Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infanrix/Hib Single Injection Group | Experimental | Subjects received 1 dose of Infanrixâ„¢ extemporaneously mixed with Hiberixâ„¢. |
|
| Infanrix + Hiberix Separate Injection Group | Active Comparator | Subjects received two separate injections, one of Infanrixâ„¢ and one of Hiberixâ„¢. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrixâ„¢ | Biological | Intramuscular injection, one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations | Geometric mean concentrations are given in microgram per milliliter (μg/mL). | One month after booster vaccination |
| Anti-diphtheria Toxoid Antibody Concentrations | Geometric mean concentrations are given in international Unit per milliliter (IU/mL). | One month after booster vaccination |
| Anti-tetanus Toxoid Antibody Concentrations | Geometric mean concentrations are given in IU/mL. | One month after booster vaccination |
| 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). | One month after booster vaccination |
| 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. | One month after booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-PRP Antibody Concentrations | Geometric mean concentrations are given in μg/mL. | Before booster vaccination |
| Anti-diphtheria Toxoid Antibody Concentrations | Geometric mean concentrations are given in IU/mL. |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Liucheng County | Guangxi | 545200 | China | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111535 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix/Hib Single Injection Group | Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix. |
| FG001 | Infanrix + Hiberix Separate Injection Group | Subjects received two separate injections, one of Infanrix and one of Hiberix. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix/Hib Single Injection Group | Subjects received 1 dose of Infanrix extemporaneously mixed with Hiberix. |
| BG001 | Infanrix + Hiberix Separate Injection Group | Subjects received two separate injections, one of Infanrix and one of Hiberix. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations | Geometric mean concentrations are given in microgram per milliliter (μg/mL). | Analysis was performed on the According To Protocol (ATP) cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | One month after booster vaccination |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infanrix/Hib Single Injection Group | Subjects received 1 dose of Infanrixâ„¢ extemporaneously mixed with Hiberixâ„¢. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at injection site | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C514867 | Hiberix |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hiberixâ„¢ | Biological | Intramuscular injection, one dose |
|
| Before booster vaccination |
| Anti-tetanus Toxoid Antibody Concentrations | Geometric mean concentrations are given in IU/mL. | Before booster vaccination |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Geometric mean concentrations are given in EL.U/mL. | Before booster vaccination |
| 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. | Before booster vaccination |
| 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. | During the 4-day follow-up period after booster vaccination |
| 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. | During the 31-day follow-up period after booster vaccination |
| 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. | During the 31-day follow-up period after booster vaccination |
| Mengshan |
| China |
| GSK Investigational Site | Wuzhou | China |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111535 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111535 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111535 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111535 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111535 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111535 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Anti-diphtheria Toxoid Antibody Concentrations | Geometric mean concentrations are given in international Unit per milliliter (IU/mL). | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | One month after booster vaccination |
|
|
|
| Primary | Anti-tetanus Toxoid Antibody Concentrations | Geometric mean concentrations are given in IU/mL. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | One month after booster vaccination |
|
|
|
| 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). | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after booster vaccination |
|
|
|
| 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. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Number | subjects | One month after booster vaccination |
|
|
|
| Secondary | Anti-PRP Antibody Concentrations | Geometric mean concentrations are given in μg/mL. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Before booster vaccination |
|
|
|
| Secondary | Anti-diphtheria Toxoid Antibody Concentrations | Geometric mean concentrations are given in IU/mL. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before booster vaccination |
|
|
|
| Secondary | Anti-tetanus Toxoid Antibody Concentrations | Geometric mean concentrations are given in IU/mL. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before booster vaccination |
|
|
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Geometric mean concentrations are given in EL.U/mL. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before booster vaccination |
|
|
|
| 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. | Analysis was performed on the ATP cohort for immunogenicity. | Posted | Number | subjects | Before booster vaccination |
|
|
|
| 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. | Analysis was performed on subjects from the Total Vaccinated Cohort with a documented dose. | Posted | Number | subjects | During the 4-day follow-up period after booster vaccination |
|
|
|
| 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. | Posted | Number | subjects | During the 31-day follow-up period after booster vaccination |
|
|
|
| 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. | Posted | Number | subjects | During the 31-day follow-up period after booster vaccination |
|
|
|
| 1 |
| 133 |
| 244 |
| EG001 | Infanrix + Hiberix Separate Injection Group | Subjects received two separate injections, one of Infanrixâ„¢ and one of Hiberixâ„¢. | 3 | 127 | 223 |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Redness at injection site | General disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| Anti-PRN |
|
| Seroprotection against tetanus (n=237, 214) |
|
| Seropositivity for anti-PT (n=239, 216) |
|
| Seropositivity for anti-FHA (n=239, 216) |
|
| Seropositivity for anti-PRN (n=239, 216) |
|
| Anti-PRN |
|
| Seroprotection against tetanus (n= 237, 214) |
|
| Seropositivity for anti-PT (n= 239, 216) |
|
| Seropositivity for anti-FHA (n= 239, 216) |
|
| Seropositivity for anti-PRN (n= 239, 216) |
|
| Swelling |
|
| Drowsiness |
|
| Fever |
|
| Irritability |
|
| Loss of appetite |
|