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This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diphtheria, tetanus, pertussis & Hib vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events |
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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 | Nanning | Guangxi | 530021 | China |
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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 |
|---|---|---|---|
| 106345 | Statistical Analysis Plan | 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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For additional information about this study please refer to the GSK Clinical Study Register |
| 106345 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106345 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106345 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106345 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 106345 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D006192 | Haemophilus Infections |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| C061963 | HibTITER protein, Haemophilus influenzae |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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