Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Phase 2
Completed
- Conditions
- Typhoid Fever
- Registration Number
- NCT01437267
- Lead Sponsor
- Novartis
- 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 endemic and an efficacious vaccine against this disease is very much needed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-Vi ELISA GMC At 6 months after last vaccination Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer At 6 months after last vaccination as compared to baseline Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer At 28 days after last vaccination as compared to baseline Anti-Vi ELISA Geometric Mean Concentration (GMC) At 28 days after last vaccination
- Secondary Outcome Measures
Name Time Method Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination During the 7-day follow-up period after vaccination Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)
Trial Locations
- Locations (1)
Research Institute for Tropical Medicine (RITM)
🇵🇭Alabang, Muntinlupa City, Philippines
Research Institute for Tropical Medicine (RITM)🇵🇭Alabang, Muntinlupa City, Philippines