Clinical study to evaluate the immune response and safety of two Diphtheria and Tetanus vaccines in healthy adolescent and adult subjects

A prospective, randomized, two-arm, parallel, single-blind, active-controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Diphtheria and Tetanus vaccine (adsorbed) for adults and adolescents I.P. of M/s. Cadila Healthcare Limited compared to Diphtheria and Tetanus vaccine (adsorbed) for adults and adolescents I.P. of M/s. Biological E Limited in healthy subjects

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026086

Enrollment

458

Registered

2020-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Diphtheria and Tetanus vaccine (adsorbed) for adults and adolescents I.P. of M/s. Cadila Healthcare Ltd.: Subjects will receive single dose (0.5 ml) of the vaccine. The vaccine will be

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects of either gender between 10 to 60 years of age 2. Healthy subjects as per the clinical judgment of the investigator based on the medical history and physical examination 3. Written informed consent from the adult subjects or from parents of the pediatric subjects. Additionally, assent from the pediatric subjects of Ã¢â?°Â¥10 years of age 4. Past history of primary immunization against tetanus and diphtheria 5. Adult subject or parents of the pediatric subjects literate enough to fill the diary card

Exclusion criteria

Exclusion criteria: 1. History of known or suspected allergy to any of the vaccine components including thiomersal (a mercury derivative) and 2-Phenoxyethanol 2. Past history of hypersensitivity reaction or serious adverse event to any prior vaccination 3. Past history of diphtheria or tetanus 4. History of vaccination against diphtheria or tetanus within the past 5 years 5. History of any acute illness within the last 1 week 6. Subjects with febrile illness (temperature Ã¢â?°Â¥37.5Ã?Â°C) at the time of enrollment 7. History of any vaccination within the past 4 weeks 8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder 9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 10. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 12. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 13. Participation in another clinical trial within the past 3 months 14. Subjects with history of alcohol or drug abuse in the past one year 15. Any other reason for which the investigator feels that the subject should not participate

Design outcomes

Primary

Measure	Time frame
Proportion of subjects with booster response to tetanus toxoid and diphtheria toxoid at the end of the studyTimepoint: Day 28 (28 days after vaccination)	—

Secondary

Measure	Time frame
Geometric mean titre of anti-tetanus and anti-diphtheria antibodies at the baseline and at the end of the studyTimepoint: Day 0 and Day 28 (28 days after vaccination);Proportion of subjects with seroprotective levels of anti-tetanus and antidiphtheria antibodies at the end of the studyTimepoint: Day 28 (28 days after vaccination)	—

Countries

India

Contacts

Public ContactDr Pavankumar Daultani

Cadila Healthcare Limited

r.mittal@zyduscadila.com079-71800000

Outcome results