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The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRV group | Experimental | Subjects will receive GSK Biologicals' human rotavirus vaccine 444563. |
|
| Placebo Group | Placebo Comparator | Subjects will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' human rotavirus vaccine 444563 | Biological | Oral, two doses. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of grade 3 solicited adverse events. | Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of each solicited adverse event. | Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. | |
| Occurrence of unsolicited adverse events. | Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose. |
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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 | Liucheng County | Guangxi | 545200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23807360 | Background | Li RC, Li YP, Mo ZJ, Luo D, Huang T, Kong JL, Wang LH, Song NS, Liu A, Zhang H, Liao X, Karkada N, Han HH. Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies. Hum Vaccin Immunother. 2013 Aug;9(8):1638-42. doi: 10.4161/hv.25076. Epub 2013 Jun 4. |
| 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 |
|---|---|---|---|
| 113518 | Dataset Specification | 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 |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Placebo |
| Biological |
Oral, two doses. |
|
| Occurrence of serious adverse events. | Throughout the study period (Day 0 to Month 2). |
| Results for study 113518 can be found on the GSK Clinical Study Register | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113518 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113518 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113518 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113518 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113518 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |