Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam

Status Completed

Clinical Trial Summary

The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam. The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.

Clinical Trial Description

This study will be an open single arm, single centre, interventional study conducted in Ho Chi Minh City, Vietnam. A sample size of 1,000 infants will be recruited to the study between 8 to 9 weeks (which is around 2 months) of age. These infants will receive two doses of the rotavirus vaccine, Rotarix with an interval of 28-37 days (or 4-5 weeks). The parents will be requested to bring the infants 2-3 days following each Rotarix vaccination to receive the standard EPI vaccinations. The infants will then be under passive and active surveillance for rotavirus-associated diarrhoea until 18 months of age. Blood samplings during pre and post vaccination and at 6, 12 and 18 month old visits will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03587389
Study type	Interventional
Source	Oxford University Clinical Research Unit, Vietnam
Contact
Status	Completed
Phase	Phase 4
Start date	March 19, 2019
Completion date	August 8, 2022

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