Health Condition 1: null- Typhoid fever
Conditions
Interventions
Intervention1: Vi-Tetanus toxoid conjugated Typhoid vaccine: Two doses of Vi-TT conjugate vaccine Peda Typhâ?¢ will be administered intramuscularly at 6 weeks interval. Each dose of the vaccine conta
Sponsors
BioMed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy children and teenagers from 6 months to 12 years of both sexes residing in ward number 107/108 of Calcutta Municipal Corporation in Kolkata . 2.Parent/ guardian of subjects who have given voluntary written informed consent and should agree to comply with all trial related instructions 3. Are not participating in or planning to participate in any trial or research during the entire study period.
Exclusion criteria
Exclusion criteria: 1. Age out of range 2. Fever (38.5°C) at the time of or in the last 72 hours before vaccination. 3. History of any undiagnosed fever/infection of more than 3 days duration within 1 month prior to vaccination 4. Any established or clinically suspected immunosuppressive or immunocompromised disorder/state (congenital or acquired- drug induced, neoplastic, tuberculosis etc) 5. History of typhoid vaccination in the last 5 years 6. Any other clinical condition considered by the investigator to be unsuitable for study participation 7. Known allergy to any of the components of Pedatyph 8. Any critreria, which in the opinion of the investigator suggests that the subject is likely to be non-complaint with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Bactec positive typhoid fever and Paratyphoid fever in the vaccinated and non-vaccinated groups Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes (from baseline to 6 weeks after first, second dose and after one year of vaccination) in the Vi IgG antibody levels and seroconversion rates (â?¥ 4 fold rise of baseline titre) in a subgroup of vaccinated subjects and to assess booster effect of second vaccination. Timepoint: 1 year;Incidence of treatment emergent adverse events- local and systemic adverse effects Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Medclin Research Pvt Ltd,
Outcome results
None listed