Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Inactivated vero-cell based Japanese encephalitis vaccine (JEEV®) 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.Indian subjects of either sex between >=3 to 2.Free from clinically significant health problems as established by medical history and protocol specified clinical laboratory tests before entering into the study as judged by the Investigator. 3.Written informed consent obtained prior to screening from subject, subjectâ??s parent/guardian or his/her legally acceptable representative. An assent will also be obtained for children and adolescents (>=10 years to 4.Ability of the subject, subjectâ??s parent/guardian or his/her legally acceptable representative to understand and comply with the requirements of the protocol. 5.Female subjects with either no childbearing potential or, if after onset of menarche, a negative pregnancy test and a willingness to practice a reliable method of contraception. 6.Acceptable methods of birth control included barrier methods (including male and female condoms), diaphragms (cervical caps) with intra-vaginal spermicide (including jellies, foams and suppositories), intra-uterine devices, hormonal contraceptives, abstinence or same sex relationships.
Exclusion criteria
Exclusion criteria: 1.History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever 2.Planned administration of any other study vaccine during the study period. 3.Any family history of Immunodeficiency or autoimmune disease. 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, HBV and HCV. 6.Subjects with history of severe uncontrolled diabetes/ cardiopulmonary/hepatobiliary / renal disorders and or malignancy. 7.Any acute infection within two weeks prior to enrolment. 8.Drug addiction within 3 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). 9.Pregnancy (positive urine pregnancy test during screening), lactation or unreliable contraception in female subjects after onset of menarche. 10.Subjects with 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) 3.Solicited and unsolicited adverse events (AEs) 4.Rate of SAEs and medically attended AEs 5.All safety laboratory parameters (Haematology & serum chemistry) for any clinically significant changes 6.Vital signs (Pulse, axillary/oral body temperature, Blood pressure and Respiratory rate)Timepoint: 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 up to 28th day after each dose 4.Until day 56 after the first vaccination 5.From baseline to day 56 6.From baseline to subsequent visits | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number and percentage of subjects seroconverted 2.Proportion of subjects achieving â?¥4-fold rise in titre 3.Geometric Mean TitresTimepoint: 1.At day 56 from baseline 2.At baseline by day 56 3.At baseline and day 56 | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Biological E. Limited
Outcome results
None listed