Status:
COMPLETED
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Lead Sponsor:
Novartis
Conditions:
Typhoid Fever
Eligibility:
All Genders
6-45 years
Phase:
PHASE2
Brief Summary
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and ...
Eligibility Criteria
Inclusion
- Main eligibility criteria:
- Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), 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 all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial.
- Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial.
- Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01229176
Start Date
March 1 2011
End Date
June 1 2012
Last Update
May 1 2014
Active Locations (2)
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1
K.E.M. Hospital Research Centre
Pune, Maharashtra, India, 411011
2
The Aga Khan University Hospital
Karachi, Pakistan, 74800