A STUDY TO EVALUATE THE IMMUNOGENICITY AND SAFETY OF BBIL?s TYPHOID Vi CAPSULAR POLYSACCHARIDE-TETANUS TOXOID PROTEIN CONJUGATE VACCINE VS REFERENCE VACCINE IN HEALTHY SUBJECTS.
- Registration Number
- CTRI/2011/08/001957
- Lead Sponsor
- Bharat Biotech International Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 981
1.Provide voluntary written and signed informed consent from volunteer or if minor from parent/legal guardian.
2.Healthy subjects in two cohorts aged 6 to 24 months, and 2 - 45 years.
3.Are not participating in or plan to participate in another research during the next three months & be available throughout study period.
4.Family does not plan to move during the study period, and housed not further that 50 Km away from the study site.
Fever of any origin or infections more than 3 days within one month prior
to screening or on the day of screening
2)Any confirmed or suspected immunosuppressive condition.
3)Any treatment with immunosuppressive or immunostimulant therapy
4)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for typhoid.
5) Life threatening or serious cardiac (NYHA grade 3&4), respiratory, gastrointestinal, hepatic, renal, endocrine and systemic disorders.
6)Have been vaccinated against typhoid fever or had exposure to typhoid fever within the last three years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The comparative assessment of the immunogenicity of the test vaccine (conjugate typhoid vaccine) versus the comparator (polysaccharide typhoid vaccine) by estimation of: <br/ ><br>1.4 fold Seroconversion rates in each treatment arm at 6 weeks post vaccination. <br/ ><br>2.4 fold Seroconversion rate in Cohort-1(2 years) from base line to 6 weeks post vaccination. <br/ ><br>3.Extent of rise of anti Vi IgG antibody from baseline values to 6 weeks post vaccination <br/ ><br>Timepoint: The comparative assessment of the immunogenicity of the test vaccine (conjugate typhoid vaccine) versus the comparator (polysaccharide typhoid vaccine) by estimation of: <br/ ><br>1.4 fold Seroconversion rates in each treatment arm at 6 weeks post vaccination. <br/ ><br>2.4 fold Seroconversion rate in Cohort-1(2 years) from base line to 6 weeks post vaccination. <br/ ><br>3.Extent of rise of anti Vi IgG antibody from baseline values to 6 weeks post vaccination <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Comparative assessment of safety and tolerability of the vaccine in all subjects up to 3 months post vaccination. <br/ ><br>2.Based on the Geometric Mean Titers of the primary objectives 1& 2 the superiority of test over reference vaccine will be determined <br/ ><br>Timepoint: 3 months