A clinical trial to evaluate the safety and reactogenicity of BEs Inactivated Japanese Encephalitis Vaccine.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2010/091/001086
- Lead Sponsor
- Biological E Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Healthy Indian adult male subjects between greater than or equal to 18 to <49 years of age.
-Free of significant health problems as established by medical history and clinical laboratory tests before entering into the study.
-Written informed consent obtained prior to screening from Subjects or their legally acceptable representative.
-Ability of the volunteer or his legally acceptable representative to understand and comply with the requirements of the protocol.
-History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever.
-Inability or unwillingness to abide by the requirements of the study
-Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
-Any acute infection at the time of 1st vaccination.
-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).
-Volunteers with history of type-I diabetes, severe cardiopulmonary disorders, hepatobiliary / renal disorders and malignancy
-Subjects with 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 events (AEs) <br/ ><br>2)Solicited and unsolicited local and systemic adverse events (AEs) <br/ ><br>3)All safety laboratory parameters (Haematology, serum chemistry and urinalysis) for any clinically significant changes. <br/ ><br>4) Vital signsTimepoint: 1)During first 60 minutes post vaccination <br/ ><br>2)During subsequent period of 7 days through subject diary and upto day 56 <br/ ><br>3)once at baseline and again at day 56. <br/ ><br>4)once at baseline and again at each scheduled visit.
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable