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.

A prospective, randomized, two-arm, parallel, active-controlled, multicentre, non-inferiority, phase III clinical trial to evaluate the immunogenicity and safety of ZyVac TCV of M/s Cadila Healthcare Limited compared to Typbar TCV of M/s Bharat Biotech International Limited in healthy adults aged 45 to 65 years - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036577

Enrollment

238

Registered

2021-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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 I.P. of M/s. Cadila Healthcare Limited (ZyVac TCV): subject will receive a single dose of 0.5 ml of the vaccine. The vaccine will be administered as IM inje

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Seroconversion rate at the end of the studyTimepoint: Day 28 (28 days after vaccination)	—

Secondary

Measure	Time frame
Geometric mean titre of anti-Vi IgG antibodies at the baseline and at the end of the studyTimepoint: Day 0 (Baseline) and Day 28 (28 days after vaccination)	—

Countries

India

Contacts

Public ContactDr Pavankumar Daultani

Cadila Healthcare Limited

r.mittal@zyduscadila.com079-71800000

Outcome results