A post-marketing surveillance study to evaluate the safety and immunological response of typhoid conjugate vaccine in healthy subjects

Phase 4

• Registration Number: CTRI/2021/11/037996
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy subjects of either gender �6 months to �45 years of age at the time of enrollment

2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator

3. No previous history of vaccination (oral or injectable) against typhoid fever

4. Informed consent from the adult subjects or from the parents of pediatric subjects. Additionally, assent from pediatric subjects aged 7 years or more

5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card

6. Adult subjects or, pediatric subjects and their parents intend to be available

for follow-up for entire duration of the study

Exclusion Criteria

1. History of hypersensitivity reaction to any component of the vaccine

2. History of laboratory confirmed or suspected typhoid fever in the past 3 years

3. Subject who have had household contact with/ and/or intimate exposure to an individual with laboratory confirmed S. typhi

4. Fever of any origin or infectious disorder of 3 days or more within the past month

5. Febrile illness (body temperature â�¥ 37.5�°C) at the time of enrollment

6. History of any vaccination within the past month

7. History of COVID-19 within the past 3 months

8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder

9. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy

10. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study

12. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)

13. Subject participated in another clinical study in the past 3 months or subject intend to participate in another clinical study within 3 months following

intended study vaccine administration

14. Subject with history of alcohol or drug abuse in the past one year

15. Any other reason for which the investigator feels that subject should not participate

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events reportedTimepoint: Throughout the study duration

Secondary Outcome Measures

Name	Time	Method
Geometric mean titre of anti-Vi IgG antibodiesTimepoint: Baseline (pre-vaccination) and 28 days after vaccination;Seroconversion rateTimepoint: 28 days after vaccination