Phase I clinical study to assess the safety of Tetanus vaccine (adsorbed)

Phase 1

Completed

• Registration Number: CTRI/2017/02/007778
• Lead Sponsor: Seasons Biologicals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-04-25
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

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:

oMedical history

oPhysical examination

oClinical judgment of the investigator

oClinical laboratory examination (subjects with clinically acceptable range during baseline screening)

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of the Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt LtdTimepoint: 28 days following vaccination

Secondary Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable