None listed
Conditions
Interventions
Intervention1: Japanese encephalitis Vaccine
(JENVAC): 0.5ml of Jenvac administerd intramuscularly at Day 0
Control Intervention1: Typbar TCV and Flu Vaccines: 1.Typbar TCV® :Single dose of 0.5 mL of
Sponsors
Bharat Biotech International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of age 1 to 2.Subject or Subjectâ??s Legally Acceptable Representative (LAR) who has been explained about all risks and benefits of the study and is willing to provide written informed consent. 3.Agree to be available for all study related visits and procedures throughout the entire duration of the study. 4.Individuals who are in good health as determined by the outcome of medical history, physical examination and based on the clinical judgement of the Principal Investigator.
Exclusion criteria
Exclusion criteria: 1.Subjects with age less than 1 year and more than 65 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 of the vaccine under study. 4.Past history of JE vaccination. 5.Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, hematological or immune disorders. 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 2months. 8.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol. 9.Previous history of hypersensitive reaction to vaccine or vaccine component. 10.Women who are pregnant or breast-feeding. 11.Married or sexually active participants who are not willing to follow effective birth control methods during the treatment period. 12.Individuals participating in any other clinical trial within one month prior to study participation or intent to participate in any other clinical trial during the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To evaluate the immunogenicity of the Test vaccine in terms of Seroconversion, Seroprotection and Geometric Mean Titers (GMTs) of JEV neutralizing antibody four weeks post vaccination in Group I and Group II.Timepoint: 1) day 0 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess and evaluate the safety of the test vaccine in Group I and Group II.Timepoint: 1) day 0 and 28 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech International Limited
Outcome results
None listed