Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diarrhea
- Rotavirus
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 89 years
- Gender
- Both males and females
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, Rota...
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.
Tracking Information
- NCT #
- NCT03587389
- Collaborators
- Hung Vuong Hospital
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Children's Hospital Number 1, Ho Chi Minh City, Vietnam
- Wellcome Trust Sanger Institute, UK
- Investigators
- Principal Investigator: Stephen Baker, Professor Oxford University Clinical Research Unit
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