None listed
Conditions
Interventions
Intervention1: Japanese Encephalitis vaccine: Liquid 0.5 ml of JENVAC is to be injected as two doses on
Day 0 and Day 28±2
Intervention2: Japanese Encephalitis vaccine: Liquid 0.5 ml of JENVAC is to
Sponsors
Bharat biotech Intl Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy Subject of age 18 to 50 years (inclusive) without significant medical history or abnormal findings at screening. 2)Willing to give signed written informed consent. 3)Available for all Study related visits and procedures for the entire duration of the Study, without any exposure to JE prior to the first screening visit based on previous clinical history. 4)Subjects willing to stay for entire study duration and follow-up period in the current residential address.
Exclusion criteria
Exclusion criteria: 1)Subjects with age less than 18 and above 50 years. 2)Fever of any origin of duration more than 3 days within one month prior to screening or on the day of screening. 3)History of malaise, head ache, anorexia at the time of screening or during the administration of the vaccine under Study. 4)Past history of JE infection. 5) Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, haematological or immune disorders. Past history of / current allergic diseases. 6) Any confirmed or suspected immunosuppressive or immunodeficient condition. 7) Use of any marketed or investigational or herbal medicine or non registered drug or vaccine for JE or other vaccine in the past 2 months. 8) Clinically relevant abnormal haematology or biochemistry values in the opinion of the investigator. 9) Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the Study Protocol. 10) Intention to travel out of the area prior to final or follow-up Visit on day 60. 11) Previous history of hypersensitive reaction to vaccine or Vaccine component.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the Study is to evaluate the safety and tolerability of the Vero cell-derived inactivated Japanese Encephalitis Vaccine in healthy volunteers of 18 to 50 years.Timepoint: 56days | — |
Secondary
| Measure | Time frame |
|---|---|
| he secondary objective is to assess and obtain immunogenicity data of the Vero cell-derived inactivated Japanese Encephalitis Vaccine in healthy volunteers of 18 to 50 years.Timepoint: 0, 28 & 56 days | — |
Countries
India
Contacts
Public ContactDr B N Patnaik
Bharat biotech Intl Ltd
Outcome results
None listed