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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000943-26 | EudraCT Number |
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The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexaâ„¢ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hibâ„¢ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infanrix hexa Group | Experimental | Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexaâ„¢ (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034. |
|
| Infanrix-IPV/Hib Group | Experimental | Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hibâ„¢ (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sampling | Procedure | A blood sample will be taken at 5 years of age, after vaccination in the primary study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). | A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL) | At Day 0 |
| Concentrations of Antibodies Against Anti-D and Anti-T | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). | At Day 0 |
| Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL). | Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination. | At Day 0 |
| Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL). | At Day 0 |
| Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs). | Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL). | At Day 0 |
| Concentrations of Antibodies Against Anti-HBs. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). | At Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Morvik | 5124 | Norway | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483640 | Background | Silfverdal SA, Assudani D, Kuriyakose S, Van Der Meeren O. Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age. Hum Vaccin Immunother. 2014;10(10):2795-8. doi: 10.4161/21645515.2014.970494. |
| 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 |
|---|---|---|---|
| 115375 | Annotated Case Report Form | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix Hexa Group | Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexaâ„¢ (administered intramuscularly) in study NCT00307034. |
| FG001 | Infanrix-IPV/Hib Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP). | A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL) | At Day 0 |
| Concentrations of Antibodies Against Anti-PRP. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL). | At Day 0 |
| Number of Subjects With Serious Adverse Events (SAEs). | Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (up to Day 46) |
| Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL | Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination. | At Day 0 |
| Oslo |
| 0130 |
| Norway |
| GSK Investigational Site | Örebro | SE-702 11 | Sweden |
| GSK Investigational Site | Umeå | SE-901 85 | Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115375 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115375 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115375 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115375 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115375 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115375 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hibâ„¢ (administered intramuscularly) in study NCT00307034.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix Hexa Group | Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexaâ„¢ (administered intramuscularly) in study NCT00307034. |
| BG001 | Infanrix-IPV/Hib Group | Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hibâ„¢ (administered intramuscularly) in study NCT00307034. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). | A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL) | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Count of Participants | Participants | At Day 0 |
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| Primary | Concentrations of Antibodies Against Anti-D and Anti-T | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Day 0 |
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| Primary | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL). | Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Count of Participants | Participants | At Day 0 |
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| Primary | Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL). | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Day 0 |
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| Primary | Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs). | Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL). | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Count of Participants | Participants | At Day 0 |
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| Primary | Concentrations of Antibodies Against Anti-HBs. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Day 0 |
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| Primary | Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP). | A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL) | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Count of Participants | Participants | At Day 0 |
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| Primary | Concentrations of Antibodies Against Anti-PRP. | Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL). | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | At Day 0 |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs). | Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Cohort, which included all subjects enrolled in the study. | Posted | Count of Participants | Participants | During the entire study period (up to Day 46) |
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| Primary | Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL | Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned. | Posted | Count of Participants | Participants | At Day 0 |
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SAEs: during the entire study period (Day 0 to Day 46)
As no vaccine was administered during the study, no safety data other than spontaneous SAEs were collected during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infanrix Hexa Group | Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexaâ„¢ (administered intramuscularly) in study NCT00307034. | 0 | 12 | 0 | 0 | ||
| EG001 | Infanrix-IPV/Hib Group | Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hibâ„¢ (administered intramuscularly) in study NCT00307034. | 0 | 46 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| D004165 | Diphtheria |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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