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: Licensed vero cell culture der
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Indian subjects of either sex between greater than or equal to 18 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 or his/her legally acceptable representative. 4.Ability of the subject or his/her legally acceptable representative to understand and comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1.Known exposure or history of any clinical manifestation of either Japanese encephalitis or Dengue or yellow fever. 2.History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever 3.Planned administration of any other study vaccine during the study period. 4.Any family history of Immunodeficiency or autoimmune disease 5.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). 6.Any confirmed or suspected Infection with HIV, HBV and HCV. 7.Subjects with history of uncontrolled diabetes, severe cardiopulmonary/ hepatobiliary / renal disorders and or malignancy. 8.Any acute infection within two weeks prior to enrolment. 9.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). 10.Pregnancy (positive pregnancy test during screening), lactation or unreliable contraception in female subjects. 11.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Seroconversion rates (SCR) as defined by percentage of subjects with anti-JEV neutralizing antibody titre â?¥1:10 PRNT50.Timepoint: 1.At day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Solicited local and systemic AEs. 2) Solicited and unsolicited local and systemic AEs captured through subject diary. 3) Solicited and unsolicited AEs. 4) Rate of SAEs and medically attended AEs. 5) All safety laboratory parameters. 6) Vital signs . 7) Proportion of subjects seroconverted. 8) Proportion of subjects achieving 4-fold rise in anti-JEV neutralising antibody titres. 9) GMT for serum dilution giving a 50%reduction in JEV-plaque counts in a PRNT. Timepoint: 1)First 30 minutes of vaccine administration 2)During 7-day post vaccination 3)During the subsequent follow up period up to 28th day. 4)Until day 56 after the first vaccination. 5)From baseline to day 56 will be assessed. 6)From baseline to subsequent visits. 7)At day 28 8)At Day 28 and Day 56 9)At Day 28 and Day 56 | — |
Countries
India
Contacts
Public ContactMr Shekhar Gupta
Biological E. Limited
Outcome results
None listed