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

A prospective, randomized, two arm, single blind, parallel, active controlled, multicentre, non-inferiority, phase II/III clinical study to evaluate the immunogenicity and safety of Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Limited compared to Tetanus vaccine (adsorbed) of M/s Serum Institute of India Limited in healthy subjects and subjects with clean minor wounds

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/05/005740

Enrollment

282

Registered

2015-05-05

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

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Ltd: Subject will receive 0.5 ml single dose of Tetanus vaccine (adsorbed) administered as deep intramuscular injection in the deltoi

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 subjectâ??s legally acceptable representative 4. Adult subject or legally acceptable representative of adolescent subject literature enough to fill the diary card

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects with sero-protective levels of anti-tetanus antibodies 28 days post-vaccinationTimepoint: 28 days following vaccination	—

Secondary

Measure	Time frame
Geometric mean titre of anti-tetanus antibodies at baseline and 28 days post-vaccinationTimepoint: 28 days following vaccination;Proportion of subjects with booster response to tetanus toxoid 28 days post-vaccinationTimepoint: 28 days following vaccination	—

Countries

India

Contacts

Public ContactDr Pavankumar Daultani

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com079-26868926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026