Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Aug 18, 2008

Keywords

ClinConnect Summary

This trial will determine the population effectiveness of Rotarix in Bangladeshi infants. The study will be conducted in both the government comparison area and the intervention area of the Matlab HDSS. To carry out the evaluation, we will introduce the Rotarix vaccine into half of the villages of the HDSS area. In villages randomized to receive Rotarix, the study will be explained to parents and if they consent to their child's participation and the child is eligible, the child will receive two doses of Rotarix during their first two EPI visits (scheduled for 6 and 10 weeks of age), if pos...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A male or female infant at least 6 weeks of age and not older than 20 weeks of age at the time of first dose of Rotarix.
• • An infant whose parent or guardian's primary residence, at the time of first EPI vaccinations, is a village selected to receive Rotarix.
• • Written informed consent obtained from the parent or guardian of the subject, prior to the subject's first study vaccination
• Exclusion Criteria:
• • Hypersensitivity to the active substance or any component in the vaccine
• • Hypersensitivity after previous administration of rotavirus vaccines.
• • Previous history of intussusception.
• • Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
• • Infants with known or suspected immunodeficiency.
• • Administration of Rotarix should be postponed in subjects suffering from an acute severe febrile illness only if that illness also results in postponement of other EPI vaccinations.