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The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3 | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity and safety after vaccination. |
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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 | Jonesboro | Arkansas | 72401 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16759769 | Background | Black S, Friedland LR, Schuind A, Howe B; GlaxoSmithKline DTaP-IPV Vaccine Study Group. Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years. Vaccine. 2006 Aug 28;24(35-36):6163-71. doi: 10.1016/j.vaccine.2006.04.001. Epub 2006 Apr 21. | |
| 18980534 |
| 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 |
|---|---|---|---|
| 213503/047 | Clinical Study Report | 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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| Fountain Valley |
| California |
| 92708 |
| United States |
| GSK Investigational Site | Oakland | California | 94612 | United States |
| GSK Investigational Site | Torrance | California | 90502 | United States |
| GSK Investigational Site | Marietta | Georgia | 30062 | United States |
| GSK Investigational Site | Woodstock | Georgia | 30188 | United States |
| GSK Investigational Site | Chicago | Illinois | 60614 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70128 | United States |
| GSK Investigational Site | Ruston | Louisiana | 71270 | United States |
| GSK Investigational Site | Berlin | New Jersey | 08009 | United States |
| GSK Investigational Site | Whitehouse Station | New Jersey | 08889 | United States |
| GSK Investigational Site | Endwell | New York | 13760 | United States |
| GSK Investigational Site | Stony Brook | New York | 11794 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Mechanicsville | Virginia | 23111 | United States |
| Background |
| Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008 Nov;7(9):1309-20. doi: 10.1586/14760584.7.9.1309. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 213503/047 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 213503/047 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 213503/047 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 213503/047 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 213503/047 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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