None listed
Conditions
Interventions
Intervention1: Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt Ltd: Dose:0.5 ml in single dose contains Tetanus toxoid â?¥5Lf to â?¤25 Lf, deep intramuscular injection in to the deltoid region
Sponsors
Seasons Biologicals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Healthy Adults of 18-45 years of age who give written informed consent prior to the study entry • Willingness to adhere to the study requirements • Subjects with good health as determined by: o Medical history o Physical examination o Clinical judgment of the investigator o Clinical laboratory examination (subjects with clinically acceptable range during baseline screening)
Exclusion criteria
Exclusion criteria: • Administration of immunoglobulin or any blood products since birth. • 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. • Subjects who had received any vaccines 6 months prior to study entry • Previous evidence of Tetanus. • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics • Major congenital or hereditary immunodeficiency. • Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days. • Subjects who have received cytotoxic agents or radiotherapy within last month • Evidence of disease or fever, 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 • Subjects having history or presence of drug abuse or alcoholism within 1 year prior to study entry • Subjects having history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products • Subjects having difficulty in donating blood and Subjects who have donated blood within the past 3 months • Pregnant and nourishing women • Subjects who are planning to leave the area of the study site before the end of the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of the Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt LtdTimepoint: 28 days following vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactHruday Kumar Reddy
Season Biologicals Pvt Ltd
Outcome results
None listed