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

A prospective, open-label, multicenter, phase IV clinical study to evaluate the long term persistence of immunological response after primary vaccination with Typhoid Vi Conjugate Vaccine and response to booster dose vaccination with Typhoid Vi Conjugate Vaccine of M/s Cadila Healthcare Limited in healthy subjects - None

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/019996

Enrollment

236

Registered

2019-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Typhoid Vi Conjugate Vaccine of M/s Cadila Healthcare Ltd: The subjects whose baseline anti-Vi IgG antibody titre is below the proposed seroprotective cut-off will be considered eligib

Eligibility

Inclusion criteria

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 Â± 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

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

Design outcomes

Primary

Measure	Time frame
-Long-term persistence of anti-Vi IgG antibodies -Seroconversion rate 28 days post-vaccinationTimepoint: Day 0 and Day 28	—

Secondary

Measure	Time frame
-Seroconversion rate 10 days post-vaccination -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	—

Countries

India

Contacts

Public ContactDr Pavankumar Daultani

Cadila Healthcare Ltd

r.mittal@zyduscadila.com079-26868926

Outcome results