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The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-dose oral live attenuated G1P[8] human rotavirus vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines |
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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 | Colonia Caroya | Córdoba Province | X5223CDT | Argentina | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Gonzalez Ayala et al. Co-administration with rotavirus vaccine rix4414 (rotarix™) does not interfere with the immunogenicity of oral polio vaccine (OPV). Poster presented at WSPID Bangkok, Thailand, 15-18 Nov 2007. | ||
| Background | Lopez P et al. Immunogenicity of an Oral Polio Vaccine is Unaffected when Co-Administered with a Human Rotavirus Vaccine RIX4414 (Rotarix™) in Latin America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008. | ||
| 21378594 | Background | Tregnaghi MW, Abate HJ, Valencia A, Lopez P, Da Silveira TR, Rivera L, Rivera Medina DM, Saez-Llorens X, Gonzalez Ayala SE, De Leon T, Van Doorn LJ, Pilar Rubio MD, Suryakiran PV, Casellas JM, Ortega-Barria E, Smolenov IV, Han HH; Rota-024 Study Group. Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J. 2011 Jun;30(6):e103-8. doi: 10.1097/INF.0b013e3182138278. |
| 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 |
|---|---|---|---|
| 444563/024 | Individual Participant Data Set | 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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| Córdoba |
| Córdoba Province |
| 5016 |
| Argentina |
| GSK Investigational Site | Río Cuarto | Córdoba Province | 5800 | Argentina |
| GSK Investigational Site | Mendoza | Mendoza Province | 5500 | Argentina |
| GSK Investigational Site | Tunuyan | Mendoza Province | 5560 | Argentina |
| GSK Investigational Site | Villanueva | Mendoza Province | 5521 | Argentina |
| GSK Investigational Site | Córdoba | 5000 | Argentina |
| GSK Investigational Site | La Plata | 1900 | Argentina |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| GSK Investigational Site | Bogotá | 805 | Colombia |
| GSK Investigational Site | Cali | Colombia |
| GSK Investigational Site | Cali Colombia | Colombia |
| GSK Investigational Site | Santo Domingo, Distrito Nacional | Sant Dom- Distrito Nacional | Dominican Republic |
| GSK Investigational Site | Santo Domingo | Dominican Republic |
| GSK Investigational Site | Comayagüela | Honduras |
| GSK Investigational Site | David | Chiriquí Province | Panamá 937, David | Panama |
| GSK Investigational Site | Panama City | Panama |
| Background | Tregnaghi M et al. Oral Human Rotavirus Vaccine RIX4414(Rotarix™) Co-administered with Routine EPI Vaccinations Including Oral Polio Vaccine(OPV) Is Highly Efficacious in Latin-America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008. |
| 16394298 | Derived | Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/024 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/024 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/024 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/024 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/024 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/024 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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