Clinical Study to assess the immune response and safety of typhoid conjugate vaccine of Cadila Healthcare Limited and compare it to typhoid conjugate vaccine of Bharat Biotech International Limited in healthy human subjects

Phase 2/3

Completed

• Conditions: Active immunization for the prevention of typhoid fever caused by Salmonella Typhi bacteria; Encounter for immunization,

• Registration Number: CTRI/2016/05/006975
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This is a randomized, parallel group, multicentre, non-inferiority phase II/III clinical trial to evaluate the immunogenicity and safety of Typhoid Vi capsular polysaccharide tetanus toxoid conjugate vaccine of M/s. Cadila Healthcare Ltd. (Test vaccine) as compared to Typhoid Vi capsular polysaccharide tetanus toxoid conjugate vaccine of M/s. Bharat Biotech International Ltd. (Reference vaccine) in healthy subjects of 6 months to 45 years of age. There will be two age cohorts in this study; Adult cohort & Pediatric cohort. The enrollment in this study will be sequential in nature wherein the adult subjects (18 to 45 years) will be enrolled prior to the enrollment of pediatric subjects (6 months to 17 years). A minimum of 238 subjects will be enrolled in this study and will receive either study vaccine as per the central computer generated randomization plan. Two blood samples will be collected; once pre-vaccination (on day 0) & another post-vaccination (on day 42) to determine anti-Vi IgG antibody titre through ELISA method. The primary efficacy/immunogenicity endpoint of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for the proportion of subjects with seroconversion (≥ 4 fold rise) for anti-Vi IgG antibodies post-vaccination. In addition, geometric mean titre of anti-Vi IgG antibodies at the baseline and at the end of study will also be calculated for both the study groups. The safety of the study vaccines will be assessed by recording the adverse events occurring during the entire course of the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-06
• Study Completion: 2016-07-11
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Healthy subjects of either gender between 6 months to 45 years of age 2.
• Informed consent from adult subjects or from subject’s legally acceptable representative for non-adult subjects.
• Additionally, assent from non-adult subjects of more than 7 years of age 3.
• Adult subject or legally acceptable representative of non-adult subject literate enough to fill the diary card.

Exclusion Criteria

• History of hypersensitivity reaction to any component of the study vaccines 2.
• History of typhoid fever or vaccination against typhoid fever within the last three years 3.
• History of any vaccination within the past 7 days 6.
• Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder 7.
• Subjects with 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.
• Participation in another clinical trial in the past 3 months 12.
• 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
Sero-conversion rate i.e., Proportion of subjects with ≥ 4 fold rise in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline	42 days post-vaccination

Secondary Outcome Measures

Name	Time	Method
Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccination	42 days post-vaccination
Sero-conversion rate in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline in both age groups	42 days post-vaccination
Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccination in subjects in both age groups	42 days post-vaccination

Trial Locations

Locations (8)

Gandhi Medical College & Hospital, Secunderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

GCS Medical College, Hospital & Research Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

GMERS Medical College & General Hospital, Vadodara; 🇮🇳 Vadodara, GUJARAT, India

Hi-Tech Medical College & Hospital, Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

Indo-US Superspeciality Hospital, Hyderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Institute of Child Health, Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Panchsheel Hospital, Delhi; 🇮🇳 Delhi, DELHI, India

SMS Medical College & Hospital, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Gandhi Medical College & Hospital, Secunderabad

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr T Ramesh Babu

Principal investigator

09247119597

ramesh_ped@yahoo.com