A Phase 4 interventional study of Rotarix vaccine in Rotavirus and Diarrhea, sponsored by Oxford University Clinical Research Unit, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 8 Weeks to 9 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by Oxford University Clinical Research Unit, Vietnam · Phase 4, Interventional, and Prevention
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.
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.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's enrollment of 818 is above the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Oxford University Clinical Research Unit, Vietnam is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
The Rotarix vaccine package consist of 1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1. The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. Rotarix is for oral use only and should under no circumstancies be injected. All participating infants will receive two doses of Rotarix vaccine following the standard Rotarix immunization protocol.
Biological: Rotarix vaccine
In this study, the 1st dose of Rotarix vaccine will be administered when infants are at ages between weeks 8-9 and the 2nd dose is 28-37 days after the 1st dose, which means that there is an interval of 28-37 days or 4-5 weeks between doses. A reminding call will be set at about 4 weeks after the 1st dose to remind parents to bring their children back to Hung Vuong Hospital for the 2nd dose of Rotarix to ensure the completion of the 2nd dose of Rotarix vaccine.
The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.
The primary endpoint is to measure the proportion of rotavirus vaccine failure events during the time period from recruitment to 18 months of age after the first dose of vaccination.
Time frame: from the recruitment to 18 months of age after the first dose of vaccination
Quantification of the antibody response following immunization
The temporal kinetics of rotavirus-specific antibody responses following immunization will be measured using virus-binding enzyme-linked immunosorbent assay (ELISA), which will be used to investigate the effect of host genetics, maternally transferred antibodies, and geospatial and epidemiological factors on the humoral response following vaccination.
Time frame: data collected during 7 site visits (Visit 1: Rotarix Dose 1, Visit 2: 2-3 after Visit 1, Visit 3: 28-37 days after Visit 1, Visit 4: 2-3 days after Visit 3, Visit 5: 6 months old, Visit 6: 12 months old, Visit 7: 18 months old)
Assessment of infecting rotavirus genotypes in vaccine failure cases
The rotavirus genotypes in vaccine failure cases will be assessed to investigate whether vaccine failure cases are a result of varying rotavirus genotypes.
Time frame: from the recruitment to 18 months of age after the first dose of vaccination
Plan to share: Undecided
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Oxford University Clinical Research Unit, Vietnam