Status:
WITHDRAWN
Shigella Sonnei OSPC-rDT Conjugate Vaccine
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Shigellosis
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide component consists of an average of ...
Detailed Description
The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a saccharide-protein conjugate composed of a fragment of S. sonnei LPS. The saccharide component consists of an average of ...
Eligibility Criteria
Inclusion
- INCLUSION \& EXCLUSION CRITERIA:
- Healthy adults, 18 to 49 years of age of either sex who do not have any of the following conditions will be eligible to participate:
- A chronic or progressive disease requiring chronic medication,
- History of splenectomy or abnormal immune system,
- History of neurological symptoms or signs, or mental illness,
- Anaphylactic shock following administration of any vaccine or any other severe allergic reaction,
- Women who are pregnant or intend to become pregnant during the vaccine study,
- Had S. sonnei shigellosis in the past year or received a S. sonnei vaccine previously,
- Have received systemic steroids during the month preceding Shigella vaccination,
- Had cancer, HIV/AIDS, Hepatitis B or C, Guillain Barre Syndrome, chronic skin disease or have abnormal liver functions or blood counts.
Exclusion
Key Trial Info
Start Date :
July 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01399424
Start Date
July 16 2011
End Date
April 25 2012
Last Update
July 2 2017
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