Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT02645032
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male and female individual 2-45 years of age
2. Participants/Parents who have voluntarily given informed consent and/or assent.
3. Participants/Parents willing to commit complying with the study procedures of the investigator and available for the entire duration of study
Exclusion Criteria:
1. Participants concomitantly enrolled or scheduled to be enrolled in another trial
2. Acute illness, in particular infectious diseases or fever (axillary temperature \> 38°C), with in three days prior to enrollment and vaccination.
3. Known history of allergy to vaccines or other medications
4. Known history of allergy to egg, chiken protein, neomycin and formaldehyde.
5. History of uncontrolled coagulopathy or blood disorders
6. Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (\> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives
8. Pregnancy \& Lactation (female adults)
9. Female with child-bearing potential during the study period. i.e., sexually active and not practicing effective acceptable contraceptive method
10. Individuals who have previously received any vaccines against typhoid fever
11. Individuals already immunized with any licensed vaccine within 4 weeks prior to enrolment/vaccination (day 0) and expected to receive other licensed vaccines within 60 days following the first dose (day 0), except for tetanus toxoid vaccine
12. Individuals who have a previously ascertained or suspected disease caused by S. typhi.
13. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
14. History of alcohol or substance abuse
15. Subject planning to move from the study area before the end of study period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
45 Years
Study:
NCT02645032
Study Brief:
Protocol Section:
NCT02645032