Status:
COMPLETED
Efficacy of Bilhvax in Association With Praziquantel for Prevention of Clinical Recurrences of Schistosoma Haematobium
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Urinary Schistosomiasis
Schistosoma Haematobium
Eligibility:
All Genders
6-9 years
Phase:
PHASE3
Brief Summary
Objectives:To reduce the risk of S. haematobium pathology recurrences during the three years following vaccine administration and to control the safety of this therapeutic strategy in children exposed...
Detailed Description
Patient inclusion (detailed criteria): Children in CI or CP classes of public schools in St Louis Region (Senegal) A male or female between, and including, 6 and 9 years of age at the time of the fir...
Eligibility Criteria
Inclusion
- Children in CI or CP classes of public schools in St Louis Region (Senegal) A male or female between, and including, 6 and 9 years of age at the time of the first vaccination Free of obvious health problems excepted schistosomiasis as established by clinical examination (W8-W1) Found positive for S. haematobium infection during the selection period (W12 à W9) : microhaematuria ≥ 2+ et Urinary Filtration, UF ≥ 50 eggs of Sh/10ml urine Written inform consent obtained from the parent or guardian of the subject (W9) and child acceptance Pretreated with 2 doses of 40mg/kg PZQ (at W9 and W8) Absence of heavy lesions of the urinary tract under echotomography (W8 et W1)
Exclusion
- Absence of written inform consent or expressed refusal from the child Vaccination other than the study vaccine within 90 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immuno-modifying drugs, actual or since previous year.
- History of allergic disease or reactions likely exacerbated by any component of the vaccine Acute disease at time of enrolment Other conditions which in opinion of the PI may potentially represent a danger for the child to be enrolled.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00870649
Start Date
February 1 2009
End Date
December 1 2012
Last Update
December 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ESPOIR Pour La Santé
Saint-Louis, Senegal