Status:
COMPLETED
Causes of Rotavirus Vaccine Failure in Zambian Children
Lead Sponsor:
Centre for Infectious Disease Research in Zambia
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Diarrhoea
Eligibility:
All Genders
6-15 years
Brief Summary
Zambia recently introduced routine infant immunization against rotavirus - the most important cause of severe gastroenteritis and diarrhoea mortality in children. Although vaccines like Rotarix are a ...
Detailed Description
The study will be conducted at Kamwala health facility in Lusaka where the Maternal Child Health (MCH) and antiretroviral therapy (ART) clinics as well as the Centre for Infectious Disease Research Za...
Eligibility Criteria
Inclusion
- Mother willing to participate voluntarily and able to provide signed informed consent (with witness in the case of illiterate participant)
- Infant eligible for rotavirus vaccine immunization as per national policy (male or female infant, 6-12 weeks old)
- Mother willing to undergo study procedures, including questionnaires, HIV counselling and testing, CD4 testing, and provide breast milk and blood sample at enrolment.
- Mother willing for child to undergo study procedures including full-course rotavirus vaccination, phlebotomy at enrolment and 1 month post-rotavirus vaccination, and presentation to clinic for collection of stool sample when infant has diarrhoea.
- Plans to remain resident in the area and willing to come for scheduled visits for the duration of the study.
Exclusion
- Contraindication to rotavirus vaccination.
- Previous administration of rotavirus vaccine to child.
- Recent immunosuppressive therapy in child (including high-dose systemic corticosteroids).
- History of ever receiving a blood transfusion or blood products, including immunoglobulins within the last 6 months, for mother and child.
- Mother plans for herself or child to move away from the study catchment area within the next two years.
- Any condition deemed by the study investigator to pose potential harm to the participants or jeopardize the validity of study results.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2016
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT01886833
Start Date
April 1 2012
End Date
April 30 2016
Last Update
August 23 2018
Active Locations (1)
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1
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia, 10101