Status:
COMPLETED
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Lead Sponsor:
Novartis
Conditions:
Typhoid Fever
Eligibility:
All Genders
6-59 years
Phase:
PHASE2
Brief Summary
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly end...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).
- Written informed consent will be obtained by the parents/ guardians before enrollment into the trial.
- Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01437267
Start Date
October 1 2011
End Date
August 1 2012
Last Update
April 10 2014
Active Locations (1)
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1
Research Institute for Tropical Medicine (RITM)
Alabang, Muntinlupa City, Philippines, 1781