Status:
COMPLETED
Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
The Chaim Sheba Medical Center
Schneider Children's Medical Center, Israel
Conditions:
Shigellosis
Eligibility:
All Genders
1-4 years
Phase:
PHASE3
Brief Summary
Shigellosis remains a serious and frequent disease throughout the world. Development of vaccines has been difficult because shigellae are habitants of and pathogens for humans only and there is no con...
Detailed Description
Shigellosis remains a serious and frequent disease throughout the world. Development of vaccines has been difficult because shigellae are habitants of and pathogens for humans only and there is no con...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Volunteers who are healthy 1-4 year old children whose parents/guardians have read the Information Sheet provided by the Principal Investigator and signed the consent form, and who will be available for follow up.
- EXCLUSION CRITERIA: Children with
- chronic diseases receiving medication;
- who have received systemic steroids during the month preceding Shigella vaccination;
- who had severe side effects following vaccinations; and
- those not available for follow up.
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
2799 Patients enrolled
Trial Details
Trial ID
NCT00368316
Start Date
January 1 2003
End Date
February 1 2009
Last Update
June 22 2012
Active Locations (2)
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1
Schneider Childrens Hospital
Petah Tikva, Israel
2
Chaim Sheba Medical Center
Tel Aviv, Israel