CTRI/2018/07/014919
Recruiting
Phase 2
A Phase II/III, Multicenter, Randomized, Single Blind Clinical Study to Compare the Immunogenicity and Safety of Tetanus Vaccine (Adsorbed) of M/S Seasons Biologicals Pvt Ltd with Tetanus Vaccine (Adsorbed) of M/S Serum Institute of India Ltd In Healthy Subjects
Seasons Biologicals Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seasons Biologicals Pvt Ltd
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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