Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Typhoid Vi Capsular Polysaccharide Tetanus Toxoid Conjugate Vaccine of M/s
Cadila Healthcare Limited: Subjects will receive 0.5 ml single dose of Typhoid Vi Capsular Polysaccharide Teta
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of either gender between 6 months to 45 years of age 2. Informed consent from adult subjects or from subjectâ??s legally acceptable representative for non-adult subjects. Additionally, assent from non-adult subjects of more than 7 years of age 3. Adult subject or legally acceptable representative of non-adult subject literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reaction to any component of the study vaccines 2. History of typhoid fever or vaccination against typhoid fever within the last three years 3. Fever of any origin or infections of more than 3 days within the past month 4. Subjects with febrile illness (temperature >= 37.5 C) at the time of enrollment 5. History of any vaccination within the past 7 days 6. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder 7. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 8. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 10. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 11. Participation in another clinical trial in the past 3 months 12. Subjects with history of alcohol or drug abuse in the past one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sero-conversion rate i.e., Proportion of subjects with â?¥ 4 fold rise in anti-Vi IgG antibodies 42 days post-vaccination as compared to baselineTimepoint: 42 days post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccinationTimepoint: 42 days post-vaccination;Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccination in subjects in both age groupsTimepoint: 42 days post-vaccination;Sero-conversion rate in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline in both age groupsTimepoint: 42 days post-vaccination | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Cadila Healthcare Ltd.
Outcome results
None listed