Infections, Rotavirus Clinical Trial
Official title:
A Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-14 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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|---|---|---|---|
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Phase 2 | |
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Phase 3 | |
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Phase 3 | |
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Phase 3 | |
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N/A | |
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| Completed |
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||
| Completed |
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Phase 3 | |
| Completed |
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Phase 2 | |
| Completed |
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| Completed |
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Phase 2 | |
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N/A |