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To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human rotavirus liquid vaccine | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs |
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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 | Hanoi | 084 | Vietnam | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21256876 | Background | Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011 Mar 3;29(11):2029-36. doi: 10.1016/j.vaccine.2011.01.018. Epub 2011 Jan 21. | |
| Background | Anh DD et al. Immunogenicity, Reactogenicity and Safety of the Oral Live Attenuated Human Rotavirus Vaccine RIX4414(Rotarixâ„¢) Oral Suspension (Liquid Formulation) in Vietnamese Infants. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008. |
| 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 |
|---|---|---|---|
| 105722 | Clinical Study Report | 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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| Nhatrang |
| 084 |
| Vietnam |
For additional information about this study please refer to the GSK Clinical Study Register |
| 105722 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105722 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105722 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105722 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105722 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |