A phase-IV open label study to evaluate safety and tolerability of BEâ??s JE vaccine in â?¥1 to 3 year old healthy children in a two dose schedule.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2016/05/006936
- Lead Sponsor
- Biological E Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Subjects of either sex who are between >=1 to <3 years at the time of 1st vaccination
2.Written informed consent obtained prior to screening from subjectâ??s Parent or the legally acceptable representative (LAR)
3.Free of clinically significant health problems as established by medical history and physical examination before entering into the study
4.Ability of the subjectâ??s Parent or the legally acceptable representative (LAR) to understand and comply with the requirements of the protocol.
1.Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
2.Any family history of Immunodeficiency or autoimmune disease.
3.Administration of chronic (defined as more than 14 days) immune-suppressants or other immune-modifying drugs within 6 months of vaccination. (For corticosteroids, this meant prednisone, or equivalent, >=0.05 mg/kg/day. Topical and inhaled steroids allowed).
4.History of severe hypersensitivity reactions (in particular to a component of the investigational vaccine, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission).
5.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg).
6.Subjects with history of severe cardiopulmonary, hepatobiliary / renal disorders and or malignancy.
7.Any acute infection within two weeks prior to enrolment.
8.Inability or unwillingness by the subjectâ??s parent or legally acceptable representative(s) to provide informed consent and to abide by the requirements of the study.
9.Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Solicited local and systemic adverse reactions (ARs). <br/ ><br>2.Solicited and unsolicited local and systemic adverse events (AEs) <br/ ><br>3.Solicited and unsolicited adverse events (AEs) <br/ ><br>4.Proportion of subjects with serious and/or unexpected adverse events. <br/ ><br>5.Rate of SAEs and medically attended AEs. <br/ ><br>Timepoint: 1.during first 30 minutes of vaccine administration. <br/ ><br>2.during 7-day (Day 0-6) post vaccination period, captured through subject diary. <br/ ><br>3.during the subsequent follow up period of 28-days after each vaccination. <br/ ><br>4.during the entire course of the study period. <br/ ><br>5.until day 56 after the first vaccination.
- Secondary Outcome Measures
Name Time Method Clinically significant changes in vital signs (Pulse, Axillary temperature and Respiratory rate)Timepoint: From baseline to day 28 and day 56.