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The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRV vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of RV GE |
| Measure | Description | Time Frame |
|---|---|---|
| Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17380232 | Background | Araujo EC, Clemens SA, Oliveira CS, Justino MC, Rubio P, Gabbay YB, da Silva VB, Mascarenhas JD, Noronha VL, Clemens R, Gusmao RH, Sanchez N, Monteiro TA, Linhares AC. Safety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy infants. J Pediatr (Rio J). 2007 May-Jun;83(3):217-24. doi: 10.2223/JPED.1600. Epub 2007 Mar 20. | |
| 24047799 |
| 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 |
|---|---|---|---|
| 444563/006 | Clinical Study Report | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Background |
| Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8. |
| 24240068 | Background | Cheuvart B, Neuzil KM, Steele AD, Cunliffe N, Madhi SA, Karkada N, Han HH, Vinals C. Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine. Hum Vaccin Immunother. 2014;10(2):505-11. doi: 10.4161/hv.27097. Epub 2013 Nov 13. |
| 15502699 | Background | De Vos B, Vesikari T, Linhares AC, Salinas B, Perez-Schael I, Ruiz-Palacios GM, Guerrero Mde L, Phua KB, Delem A, Hardt K. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 2004 Oct;23(10 Suppl):S179-82. doi: 10.1097/01.inf.0000142370.16514.4a. |
| 19289978 | Background | De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177. |
| 16098636 | Background | Linhares AC, Ruiz-Palacios GM, Guerrero ML, Salinas B, Perez-Schael I, Clemens SA, Innis B, Yarzabal JP, Vespa G, Cervantes Y, Hardt K, De Vos B. A short report on highlights of world-wide development of RIX4414: a Latin American experience. Vaccine. 2006 May 1;24(18):3784-5. doi: 10.1016/j.vaccine.2005.07.027. Epub 2005 Jul 26. |
| 16804845 | Background | Linhares AC, Verstraeten T, Wolleswinkel-van den Bosch J, Clemens R, Breuer T. Rotavirus serotype G9 is associated with more-severe disease in Latin America. Clin Infect Dis. 2006 Aug 1;43(3):312-4. doi: 10.1086/505493. Epub 2006 Jun 23. |
| 17624838 | Background | Perez-Schael I, Salinas B, Tomat M, Linhares AC, Guerrero ML, Ruiz-Palacios GM, Bouckenooghe A, Yarzabal JP. Efficacy of the human rotavirus vaccine RIX4414 in malnourished children. J Infect Dis. 2007 Aug 15;196(4):537-40. doi: 10.1086/519687. Epub 2007 Jun 29. |
| 17606534 | Background | Ruiz-Palacios GM, Guerrero ML, Bautista-Marquez A, Ortega-Gallegos H, Tuz-Dzib F, Reyes-Gonzalez L, Rosales-Pedraza G, Martinez-Lopez J, Castanon-Acosta E, Cervantes Y, Costa-Clemens S, DeVos B. Dose response and efficacy of a live, attenuated human rotavirus vaccine in Mexican infants. Pediatrics. 2007 Aug;120(2):e253-61. doi: 10.1542/peds.2006-2630. Epub 2007 Jul 2. |
| 16148848 | Background | Salinas B, Perez Schael I, Linhares AC, Ruiz Palacios GM, Guerrero ML, Yarzabal JP, Cervantes Y, Costa Clemens S, Damaso S, Hardt K, De Vos B. Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: A randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J. 2005 Sep;24(9):807-16. doi: 10.1097/01.inf.0000178294.13954.a1. |
| Background | Soriano-GabarrĂ³ M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1) Supplement: S28-S32. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/006 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/006 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/006 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/006 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 444563/006 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |