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To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFANRIX | Biological | |||
| BOOSTRIX | Biological | |||
| HAVRIX | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc) | ||
| Occurrence of local injection site reactions (1M after vacc). |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc), | ||
| Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30), | ||
| SAEs (full study). |
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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 | Carlton | Victoria | 3053 | Australia |
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| 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 |
|---|---|---|---|
| 263855/035 | 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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| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C505143 | Boostrix |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/035 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/035 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/035 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/035 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 263855/035 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |