Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT00134732
Brief Summary:
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. This study will provide data for Korean regulatory authorities about the immunogenicity and safety of this vaccine in Korean children aged 2 months at the time of the first dose.
Detailed Description:
The study consists of two groups of children recruited in different centers in Korea. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 2 months of age according to a two dose schedule (0, 2 months). The study will consist of three visits. At the first visit, one blood sample will be taken before vaccination and the first dose will be administered. At the second visit (2 months after first dose), the second vaccine will be administered. At the third visit (2 months after second dose), a blood sample will be taken. A 15-day (Day 0 - 14) follow-up period will be observed for general symptoms solicited in the study (fever, fussiness/irritability, diarrhea, vomiting, loss of appetite and cough/runny nose). A 43-day (Day 0 - 42) follow-up will be observed for other unsolicited symptoms. Serious adverse events will be followed-up throughout the study. A stool sample should be collected from the child at any point during the study if he/she develops any GE.
Study:
NCT00134732
Study Brief:
Protocol Section:
NCT00134732