None listed
Conditions
Interventions
Intervention1: JENVAC: purified inactivated JE vaccine, JENVAC manufactured By BBIL, Liquid 0.5mL of JENVAC will be injected as single dose on day 0 by intramuscular route.
Control Intervention1: SA 1
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy volunteers of 1 to 15 years age group (inclusive) without significant medical history or abnormal findings at screening 2.Parents/legal representative 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 known exposure to JE prior to the first screening visit based on previous clinical history.
Exclusion criteria
Exclusion criteria: 1.Subjects with the age less than 1 year or more than 15 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, headache, 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. 6.History of allergic diseases. 7.Any confirmed or suspected immunosuppressive or immunodeficient condition 8.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. 9.Previous history of hypersensitive reaction to vaccine or vaccine component.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMT and seroconversion of JE antibodies on day 28±2 (days) Timepoint: 28±2 (days) | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT and seroconversion on days 56±7 (days), 90±10(days), 180±15(days), 360±15(days)Timepoint: 56±7(days), 90±10(days), 180±15(days), 360±15(days) | — |
Countries
India
Contacts
Public ContactDr Binod Sah
Bharat Biotech International Limited
Outcome results
None listed