None listed
Conditions
Interventions
Intervention1: Japanese Encephalitis Vaccine Inactivated (Adsorbed, Human) I.P. of HBI: Group A(18 to 49 years of age)
Group B(12 to below 18 years of age) will be administered Two doses (of 0.5 ml e
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male subjects of 18 to 49 years and 12 to below18 years of age. Judged to be in good health based on reported medical history physical examination and clinical judgement of the investigator Subject or Parent or LAR is literate and has understood and signed the written informed consent prior to the study inclusion. Subjects of 12 to below 18 years of age have provided Assent Plans to remain in the study area for the entire length of the trial
Exclusion criteria
Exclusion criteria: Past history of Japanese Encephalitis or Dengue infection History of receipt of licensed or experimental Japanese Encephalitis or Yellow Fever or Dengue vaccine Participation in another clinical trial in the four weeks preceding the trial vaccination Planned participation or planning to participate in any other clinical trial during the present trial period Subject who has a known history of allergy to any component of the vaccine Known or suspected primary or acquired disease of the immune system Allergy immunotherapy or receiving immunosuppressive therapy except for using topical steroids Subjects on treatment with any hepatotoxic drug before receiving the vaccine during the last 90 days History of any significant underlying disease including but not limited to malignancy cardiopulmonary disease renal endocrinologic hematologic or hepatic dysfunction Having diabetes mellitus type I or II Known or suspected acute respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea new cough pharyngitis and respiratory problems eg wheezing and shortness of breath Asthma that is unstable or required emergent care urgent care hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids Any fever with axillary temperature greater than equals to 38 Celsius 100 4 Fahrenheit in last 3 days Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms History of recent contact with any confirmed case of COVID 19 or having tested positive for COVID 19 since less than a month Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days Any known history of thrombocytopenia or a bleeding disorder History or suspicion of HIV HCV or Hepatitis B Any history of receipt of blood products in last 3 months Any condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Solicited/unsolicited local adverse events after each dose of vaccination and during the 4-6 weeks follow-up period in each age group. Solicited/unsolicited systemic adverse events after each dose of vaccination and during the 4-6 weeks follow-up period in each age group. Number of serious adverse events during the study period in each age group. Timepoint: 4-6 weeks after second dose of vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity Seroprotection seroconversion rate in each group 4 to 6 weeks after the second dose of vaccination Geometric mean titres of antibodies in each age group 4 to 6 weeks after the second dose of vaccination Timepoint: 4 to 6 weeks after second dose of vaccination | — |
Countries
India
Contacts
Public ContactDr Sai Krishna
Human Biologicals Institute
Outcome results
None listed