None listed
Conditions
Interventions
Intervention1: Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt Ltd: Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt Ltd
Control Intervention1: Tetanus Vaccine (Adsorbed) of Serum Institute
Sponsors
Seasons Biologicals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of either gender, between 10-45 years of age who give written informed consent prior to the study entry. Children and adolescent (between the age group of 10 -17) having signed the assent consent form 2. Subject with clean minor wound(s) who had been warranted for receiving Tetanus Toxoid (Adsorbed) 3. Willingness to adhere to the study requirements 4. Subjects with good health as determined by: Medical history, Physical examination, Clinical judgment of the investigator and Clinical laboratory examination (subjects with clinically acceptable range during baseline screening)
Exclusion criteria
Exclusion criteria: 1. Administration of immunoglobulin or blood or any blood products since birth. 2. Use of any investigational or un-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the study vaccination. 3. Subjects who had received any vaccines 6 months prior to study entry 4. Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years 5. Previous evidence of Tetanus. 6. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics 7. Major congenital or hereditary immunodeficiency. 8. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days or planned administration during the study period. 9. Subjects with febrile illness (temperature > 38 degree centigrade) at the time of enrollment 10. Subjects who have received cytotoxic agents or radiotherapy within last month 11. Evidence of disease or history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives 12. Subjects having history or presence of drug abuse or alcoholism within one year prior to study entry 13. Subjects having history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products 14. Subjects having difficulty in donating blood and Subjects who have donated blood within the past 3 months 15. Pregnant and nourishing women 16. Subjects who are planning to leave the area of the study site before the end of the study period. 17. Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Immunogenicity of Tetanus Vaccine (Adsorbed) of M/S Seasons Biologicals Pvt Ltd in comparison with the commercially available Tetanus Vaccine (Adsorbed) of M/S Serum Institute of India LtdTimepoint: 28 days following vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of the Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt LtdTimepoint: 28 days following vaccination | — |
Countries
India
Contacts
Public ContactHruday Kumar Reddy
Seasons Biologicals Pvt Lyd
Outcome results
None listed