A Phase IV, single dose JENVAC (Inactivated JE Vaccine) vs. Chinese SA-14-14-2 (Live JE Vaccine) vaccine
- Registration Number
- CTRI/2014/02/004386
- Lead Sponsor
- Bharat Biotech International Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity: <br/ ><br>To determine the seroconversion of JE antibody titers after single dose vaccine administration as compared to baseline of test vaccine <br/ ><br>To evaluate and compare the seroconversion and GMTs of test and reference vaccine as compared to baseline. <br/ ><br>NOTE: Proportion of participants that are seronegative at baseline (1:10) will require a PRNT50 titer of â?¥1:10 to meet the criteria for seroconversion. <br/ ><br>Timepoint: To evaluate the seroconversion of JE antibody titers at day 28, day56, day 90, day 180 and day 360 as compared to baseline of test <br/ ><br>vaccine. <br/ ><br>Comparison of GMT and Seroconversion of JE antibodies day 28,day 56, day 90, day 180 and day 360 between the study groups.
- Secondary Outcome Measures
Name Time Method Safety: To assess and compare the safety of test and reference vaccine when administered as single dose.Timepoint: one year