Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Inactivated vero-cell based Japanese encephalitis vaccine of BE LTD: 6µg/0.5mL dose administered intramuscularly on 0 and 28th day
Control Intervention1: None: None
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of either sex who are between >=18 to 2.Written informed consent obtained prior to screening from subjects or their legally acceptable representative 3.Free of clinically significant health problems as established by medical history and physical examination before entering into the study 4.Ability of the subject or his/her legally acceptable representative to understand and comply with the requirements of the protocol 5.Negative Pregnancy test for women of child bearing potential prior to entry into the trial.
Exclusion criteria
Exclusion criteria: 1.Known exposure or history of any clinical manifestation of Japanese encephalitis, Dengue or yellow fever. 2.History of any previous vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever. 3.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. 4.Any family history of Immunodeficiency or autoimmune disease. 5.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). 6.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). 7.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg). 8.Subjects with history of uncontrolled diabetes, severe cardiopulmonary, hepatobiliary / renal disorders and or malignancy. 9.Any acute infection within two weeks prior to enrolment. 10.Drug addiction within 6 months prior to enrolment (including alcohol dependence, i.e. more than approx. 60 mL of alcohol per day, or conditions which might interfere with the study conduct). 11.Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects. 12.Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Solicited local and systemic adverse events (AEs) 2.Solicited and unsolicited local and systemic adverse events (AEs)captured through subject diary. 3.Solicited and unsolicited adverse events (AEs) 4.Proportion of subjects with serious and/or unexpected adverse events 5.Rate of SAEs and medically attended AEs 6.95% CI for proportion of adverse events reportedTimepoint: 1.During first 30 minutes of vaccine administration 2.During 7-day (Day 0-6) post vaccination period. 3.During the subsequent follow up period of 28-days after each vaccination 4.During the entire course of the study period 5.Until day 56 after the first vaccination 6.During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically significant changes in vital signs (Pulse, Oral body temperature, Blood Pressure and Respiratory rate)Timepoint: From baseline to day 28 and day 56 | — |
Countries
India
Contacts
Public ContactMr Shekhar Gupta
Biological E. Limited
Outcome results
None listed