A clinical study to assess the long-term immune response after primary vaccination and immune response after re-vaccination with typhoid conjugate vaccine

Phase 4

• Registration Number: CTRI/2019/07/019996
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects who had participated and completed the previously conducted phase II/III clinical study (Project No. 15-03) and had received the study vaccine before 3 years ± 3 months

2. Informed consent from adult subjects or from parents of the pediatric subjects. Additionally, assent from pediatric subjects of >=7 years of age

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

Exclusion Criteria

1. History of typhoid fever or vaccination against typhoid fever after previous study

2. Subjects administered blood, blood containing products or immunoglobulins during the past 3 months

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

4. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy

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

6. Participation in another clinical trial in the past 3 months

7. Subjects with history of alcohol or drug abuse in the past one year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Long-term persistence of anti-Vi IgG antibodies <br/ ><br>-Seroconversion rate 28 days post-vaccinationTimepoint: Day 0 and Day 28

Secondary Outcome Measures

Name	Time	Method
-Seroconversion rate 10 days post-vaccination <br/ ><br>-Geometric mean titre of anti-Vi IgG antibodies 10 days and 28 days post-vaccination as compared to the baselineTimepoint: Day 10 and Day 28