None listed
Conditions
Interventions
Intervention1: TT of Bio Vaccine: Tetanus Toxoid Vaccine of Bio Vaccine
Control Intervention1: TT of Serum: Tetanus Toxoid Vaccine of Serum
Sponsors
BIO VACCINES
Eligibility
Inclusion criteria
Inclusion criteria: A prospective, age descending, 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 BioVaccines (India) Pvt. Ltd. compared to Tetanus vaccine (adsorbed) of M/s Serum Institute of India Limited in healthy subjects aged 10-60 years of age. Protocol Number: BV/CR/0012018/CT Version Number: 03 Dated 05-02-2018
Exclusion criteria
Exclusion criteria: 1. The parents or legal guardians of subjects 10-17 years of age are unwilling or unable to give written informed consent to participate in the study. 2. Subject unwilling to give his/her assent (if applicable) to participate in the trial. 3. Subjects with incomplete or no history of a primary series of vaccination with tetanus containing vaccine. Primary series is defined as vaccination with 4 doses of DTP vaccine in the first two years of age. 4. Subjects who have received the last dose of tetanus or diphtheria toxoid-containing vaccines more than 5 years back. 5. Subjects who have presented a previous disease potentially related to any of the agents targeted by the Tetanus vaccine 6. Subjects with known hypersensitivity to any component of the study vaccine or a life threatening reaction after previous administration of the vaccine or a vaccine containing the same substances. 7. Subject is suffering from acute severe febrile illness. 8. Evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy 9. Subjects with pre-existing autoimmune illnesses like rheumatoid arthritis, lupus, multiple sclerosis etc. 10. Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus. 11. Subjects with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy 12. Presence of significant cardiovascular, hepatic, renal, pulmonary (including respiratory depression or diseases involving obstruction/ narrowing of airways), gastrointestinal, endocrine, dermatological, neurological or psychiatric disease or disorder, cancer or autoimmune disease under treatment that in the opinion of the investigator, are likely to interfere with study outcome or study subject safety. 13. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressantâ??s or other immune-modifying drugs in the past or any time during the study or intake of any other medications which may interfere with study volunteers self assessing ability / safety. 14. Known history of administration of blood or blood-derived products in the past 3 months 15. Significant alcoholism or drug abuse which may interfere with study volunteers self assessing ability / safety. 16. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception. 17. Subjects who in the opinion of the investigator are not suitable for inclusion 18. Subjects who have participated in other trials 3 months prior to enrollment. 19. Planned participation in another clinical trial during the trial period. 20. Subjects planning to leave the area of study site before completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion/percentage of subjects achieving significant immunogenic booster response, 4 weeks after single booster doseTimepoint: â?¢ Proportion/percentage of subjects achieving significant immunogenic booster response, 4 weeks after single booster dose | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Proportion/percentage of subjects achieving significant immunogenic booster response, 4 weeks after single booster doseTimepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Devesh Gupta
BIO VACCINES INDIA PVT LTD
Outcome results
None listed