CTRI/2018/07/014919RecruitingPhase 2/3
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 Ltd6 sites in 1 country180 target enrollmentStarted: July 23, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 6
- Primary Endpoint
- To evaluate the Immunogenicity of Tetanus Vaccine (Adsorbed) of M/S Seasons Biologicals Pvt Ltd in comparison with the
Study Overview
Brief Summary
This is an randomized, single blind, comparative, multicenter, prospective clinical study, designed to assess the immunogenicity and safety of Tetanus Toxoid (Adsorbed) vaccine developed by Seasons Biologicals Pvt Ltd in comparison with commercially available Tetanus Toxoid (Adsorbed) of Serum Institute of India Ltd in healthy subjects.
Approximately 180 subjects will be enrolled in this study. Consenting subjects meeting the eligibility criteria of the study will be randomized in a 2:1 ratio to receive single dose of 0.5 ml of Seasons Biologicals Pvt Ltd vaccine OR Serum Institute of India Ltd vaccine, deep intramuscularly into the deltoid region.
Immunogenicity and safety of the vaccine will be assessed after 28 days of vaccination.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 10.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •Willingness to adhere to the study requirements
- •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
- •Administration of immunoglobulin or blood 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
- •Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years
- •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 or planned administration during the study period.
- •Subjects with febrile illness (temperature > 38 degree centigrade) at the time of enrollment
- •Subjects who have received cytotoxic agents or radiotherapy within last month
- •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
- •Subjects having history or presence of drug abuse or alcoholism within one 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.
- •Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study.
Outcomes
Primary Outcomes
To evaluate the Immunogenicity of Tetanus Vaccine (Adsorbed) of M/S Seasons Biologicals Pvt Ltd in comparison with the
Time Frame: 28 days following vaccination
commercially available Tetanus Vaccine (Adsorbed) of M/S Serum
Time Frame: 28 days following vaccination
Institute of India Ltd
Time Frame: 28 days following vaccination
Secondary Outcomes
- To evaluate the safety and tolerability of the Tetanus Vaccine (Adsorbed) of Seasons Biologicals Pvt Ltd(28 days following vaccination)
Investigators
Study Sites (6)
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