A clinical research study to assess the immune response and safety of two typhoid vaccines in healthy adult subjects of 45 to 65 years of age.

Phase 3

Completed

• Registration Number: CTRI/2021/09/036577
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-22
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 238

Inclusion Criteria

1. Subjects of either gender of 45 to 65 years of age (both inclusive)

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. Written informed consent from the subjects

5. Subjects literate enough to fill the diary card

Exclusion Criteria

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

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

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

4. Febrile illness (body temperature >= 37.5oC) at the time of enrollment

5. History of any vaccination within the past month

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

7. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or

subjects on any immunosuppressive or immunostimulant therapy

8. Known case of thrombocytopenia or any coagulation disorder, or subjects on

anticoagulation therapy

9. Subjects administered blood, blood containing products or immunoglobulins within

the last 3 months or planned administration during the study

10. Pregnant and lactating women & female subjects not using acceptable contraceptive

measures (double barrier methods, oral or injectable hormonal contraceptives or

surgical sterilization)

11. Subject participated in another clinical study in the past 3 months

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified