Clinical study to evaluate and compare the immunogenicity and safety of Tetanus vaccine of Cadila Healthcare Ltd. vs Tetanus vaccine of Serum Institute of India Ltd. in healthy subjects and subjects with clean minor wounds

Phase 2/3

Completed

• Conditions: Booster immunization for the prevention of Tetanus in healthy subjects & subjects with clean minor wounds; Encounter for immunization,

• Registration Number: CTRI/2015/05/005740
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This is a randomized, single blind, parallel, active controlled, non-inferiority, multicentre clinical trial to evaluate and compare the immunogenicity and safety of Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Ltd. with Tetanus vaccine (adsorbed) of M/s Serum Institute of India Ltd. in healthy subjects and subjects with clean minor wounds. Blood samples will be collected pre-vaccination (day 0) & post-vaccination (day 28) to determine anti-tetanus antibody titre. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for proportion of subjects with sero-protective levels of anti-tetanus antibodies post-vaccination. The sero-protective cut-off titre for serum anti-tetanus antibodies is 0.1 IU/ml. The booster response to vaccination will be considered as per following criteria: Post-vaccination titre of ≥ 0.4 IU/ml for individuals with pre-vaccination antibody concentrations of < 0.1 IU/ml or; Four fold or greater antibody rise post-vaccination for participants with pre-vaccination antibody concentrations ≥ 0.1 IU/ml but < 2 IU/ml or; Two fold or greater antibody response post-vaccination for participants with pre-vaccination antibody levels ≥ 2 IU/ml.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" / The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study.

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-03-09
• Study Start: 2015-07-05
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Healthy subject or subject with clean minor wound(s) of either gender between 10-40 years 2.
• History of previous immunization with tetanus toxoid containing vaccine 3.
• Written informed consent from adult subjects; or assent from adolescent subject in addition to written informed consent from subject’s legally acceptable representative 4.
• Adult subject or legally acceptable representative of adolescent subject literature enough to fill the diary card.

Exclusion Criteria

• Past history of hypersensitivity reaction, neurological disorder or any serious adverse event to any component of tetanus toxoid containing vaccine including thiomersal (a mercury derivative) and 2-Phenoxyethanol 2.
• Past history of tetanus 3.
• Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years 4.
• Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 5.
• Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 6.
• Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder 7.
• History of any acute illness within the last 1 week 8.
• Subjects with febrile illness (temperature ≥ 38oC) at the time of enrollment 9.
• Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 10.
• Any other parenteral vaccine administration within the last 30 days 11.
• Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 12.
• Participation in another clinical trial in the past 3 months 13.
• 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
Proportion of subjects with sero-protective levels of anti-tetanus antibodies 28 days post-vaccination	28 days following vaccination

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with booster response to tetanus toxoid 28 days post-vaccination	28 days following vaccination
Geometric mean titre of anti-tetanus antibodies at baseline and 28 days post-vaccination	28 days following vaccination

Trial Locations

Locations (6)

Cheluvamba Hospital, Mysore; 🇮🇳 Mysore, KARNATAKA, India

GMERS Medical College & Civil Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

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

Hi-Tech Medical College and Hospital, Bhubaneshwar; 🇮🇳 Khordha, ORISSA, India

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

K R Hospital, Mysore; 🇮🇳 Mysore, KARNATAKA, India

Cheluvamba Hospital, Mysore

🇮🇳Mysore, KARNATAKA, India

Dr Pradeep N

Principal investigator

09611898080

drpradeepn80@yahoo.com