A clinical study to vaccinate healthy adults with a single human dose of a licensed Typhoid Conjugate Vaccine and collection of immune sera for development of testing standards for anti- typhoid antibody estimation.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2018/01/011500
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Provide voluntary written and signed informed consent from volunteer.
2. Healthy subjects aged 18 to 30 years of both gender.
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.
1. 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. Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for typhoid.
4. In receipt of systemic immunosuppressant or systemic corticosteroids.
5. Prior or anticipated receipt of immune globulin or other blood products, or other immune modulator therapy.
6. Life threatening or serious cardiac, respiratory, gastrointestinal, hepatic, renal, endocrine and systemic disorders.
7. Have been vaccinated against typhoid fever or had exposure to typhoid fever within the last three years.
8. Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
9. 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 1.To collect immune sera samples from each enrolled subject.Timepoint: 1.Day 28 post single dose of vaccine administration.
- Secondary Outcome Measures
Name Time Method oneTimepoint: None