TypbarTCV-Typhoid vaccine Phase-IV clinical trial Compare to Sanofi Pasteurâ??s Typhim Vi® vaccine.
- Registration Number
- CTRI/2016/01/006476
- Lead Sponsor
- Bharat Biotech International Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 340
1. Healthy subjects aged between 2 to 15 years at the time of enrollment.
2. Subject has not previously been documented to have received a typhoid vaccine.
3. Subjects are not currently participating in any other clinical trial or are in receipt of any
other investigational product in the last 06 months
4. Subject parents or legally acceptable representative (LAR) is willing and able to provide,
audio-video recorded and signed, informed consent.
5. Subject parents or family and the subject intend to remain in the area during the study period
and be available for follow up.
1.Acute medical illness with or without fever within the last 72 hours or an axillary temperature >=37.5°C at the time of enrolment [temporary exclusion, till a febrile].
2.Known or suspected impairment of immunologic function.
3.In receipt of systemic immunosuppressant or systemic cortico-steroids. Individuals on a tapering dose schedule of oral steroids lasting <7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment. Prior or anticipated receipt of immune globulin or other blood products, or other immune modulator therapy except routine vaccines within 6 weeks of administration of the study vaccines.
4.Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
5.Any condition that, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate non-inferiority of the immune response of Typbar-TCV� as compared to Typhim Vi®, 28 days after vaccine administrationTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method The proportion of subjects attaining seroconversion of anti-Vi antibodies (more than fourfold rise in antibody titre compared to baseline), 90 days after vaccine <br/ ><br>administration in both treatment groupsTimepoint: 90 days