CTRI/2017/03/008003
Completed
Phase 1
A phase-I, open label clinical trial to assess the safety of tetanus toxoid,reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinemanufactured by Serum Institute of India Pvt. Ltd. in healthy Indianadults
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Sponsor
- Serum Institute of India Pvt Ltd
- Enrollment
- 23
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy adult male or female aged between 18\-45 years and normal
- •Body Mass Index (18\.5 to 24\.9 kg/m2\) with minimum of 50 kg
- •2\. Healthy subjects as established by personal medical history, physical
- •examination, laboratory investigation during screening and as per the
- •clinical judgment of the Investigator.
- •3\. Sexually active participants to be using an effective method of
- •contraception (i.e. intrauterine device or hormonal contraception or
- •condom, diaphragm, cervical cap).
- •4\. Subjectâ??s willingness and ability to comply with the requirements of
- •the protocol.
Exclusion Criteria
- •1\. History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except
- •Tetanus\-prone wound management for adults) in the past 5 years.
- •2\. History of Tetanus, diphtheria or pertussis infection.
- •3\. Female participant who is pregnant or breast\-feeding, or wanting to fall pregnant during study.
- •4\. History of any major illness.
- •5\. History of major congenital defects or illness.
- •6\. Investigator, site personnel directly affiliated with this study and their immediate families.
- •7\. Acute illness and/or fever at the time of vaccination or during the past 7 days.
- •8\. Chronic administration high doses of
- •corticosteroids, cytotoxic agents or radiotherapy or immune\-modifying drugs in last 3 months.
Outcomes
Primary Outcomes
Not specified
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