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The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRV vaccine | Biological | Two or three oral doses |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion after HRV vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety |
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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 | Brits | 0250 | South Africa | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarixâ„¢ (RIX4414) in South African infants. Abstract presented at the 9th dsRNA Virus Meeting. Cape Town, South Africa, 21-26 Oct 2006. | ||
| Background | Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarixâ„¢ (RIX4414) in South African infants. Abstract presented at ASCOOD. Bangkok, Thailand, 8-10 March 2006. | ||
| Background | Steele AD et al. Difference in immune responses between 2 different regimens of RIX4414 ( 106.5 CCID50 viral concentration) in South Africa. Abstract presented at the 4th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Warsaw, Poland, 01-04 Sept 2005. |
| 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 |
|---|---|---|---|
| 444563/013 | 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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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Ga-Rankuwa |
| 0208 |
| South Africa |
| GSK Investigational Site | Pretoria | 2 | South Africa |
| GSK Investigational Site | Pretoria North | 2 | South Africa |
| GSK Investigational Site | Rooihuiskraal | 0145 | South Africa |
| GSK Investigational Site | Sunnyside, Pretoria | 2 | South Africa |
For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/013 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/013 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/013 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/013 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/013 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |