This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study.
This Protocol Posting has been updated following an amendment of the Protocol.
Study Type
OBSERVATIONAL
Enrollment
1,270
Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.
Stools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples.
GSK Investigational Site
Singapore, Singapore
To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age.
Time frame: At least one year
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis (RV SGE) among children born after 1 November 2005 and aged at least 16 weeks.
Time frame: At least one year
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing hospitalisation for acute RV GE among children born after 1 November 2005 and aged at least 16 weeks.
Time frame: At least one year
To determine the distributions of acute RV GE associated hospital admissions according to subject's age, gender and by month of year.
Time frame: At least one year
To estimate the prevalence of RV genotypes in acute RV GE associated hospital admission.
Time frame: At least one year
To review the trend of acute RV GE and acute GE admissions over the entire study period.
Time frame: At least one year
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