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| ID | Type | Description | Link |
|---|---|---|---|
| 105752 | Other Identifier | GSK |
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This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.
"There will be two groups in this study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infanrix hexa Group | Active Comparator | Subjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTPa-HBV-IPV/Hib | Biological | GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL. | At Month 0 |
| Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL. | At Month 3 |
| Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL. | At Month 5 |
| Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL. | At Month 7 |
| Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | At Month 0 |
| Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. |
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Inclusion criteria For the primary vaccination phase
Exclusion criteria For the primary vaccination phase
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18410769 | Background | Knuf M, Schmitt HJ, Wolter J, Schuerman L, Jacquet JM, Kieninger D, Siegrist CA, Zepp F. Neonatal vaccination with an acellular pertussis vaccine accelerates the acquisition of pertussis antibodies in infants. J Pediatr. 2008 May;152(5):655-60, 660.e1. doi: 10.1016/j.jpeds.2007.09.034. Epub 2007 Nov 19. | |
| 20303444 | Background |
| 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 |
|---|---|---|---|
| 210602-002 | 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.
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| At Month 3 |
| Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | At Month 5 |
| Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | At Month 7 |
| Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL. | At Month 1 Post-Booster |
| Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. | At Month 1 Post-Booster |
| Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration. | At Month 7 |
| Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies | Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration. | At Month 1 Post-Booster |
| Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Month 7 |
| Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At pre-booster vaccination (Month 0 BST) |
| Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies | A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. | At Month 1 post-booster vaccination |
| Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL. | At Month 7 |
| Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL. | At pre-booster vaccination (Month 0 BST) |
| Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL. | At Month 1 post-booster vaccination |
| Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL. | At Month 7 |
| Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL. | At pre-booster vaccination (Month 0 BST) |
| Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL. | At Month 1 post-booster vaccination |
| Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL. | At Month 7 |
| Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL. | At pre-booster vaccination (Month 0 BST) |
| Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL. | At Month 1 post-booster vaccination |
| Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP) | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL. | At Month 7 |
| Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP) | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL. | At pre-booster vaccination (Month 0 BST) |
| Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP) | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL. | At Month 1 post-booster vaccination |
| Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP) | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL. | At Month 7 |
| Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP) | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL. | At pre-booster vaccination (Month 0 BST) |
| Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP) | Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL. | At Month 1 post-booster vaccination |
| Number of subjects with solicited general symptoms | The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = > 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. | During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination |
| Number of subjects with unsolicited adverse events (AES) | An AE was defined as 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. | Occurring within Day 0-30 following primary and booster vaccination |
| Knuf M, Schmitt HJ, Jacquet JM, Collard A, Kieninger D, Meyer CU, Siegrist CA, Zepp F. Booster vaccination after neonatal priming with acellular pertussis vaccine. J Pediatr. 2010 Apr;156(4):675-8. doi: 10.1016/j.jpeds.2009.12.019. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 210602-002 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 210602-002 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 210602-002 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 210602-002 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 210602-002 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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