None listed
Conditions
Interventions
Intervention1: JENVAC: JENVAC�®
Liquid NLT 5.0�µg/0.5mL (SHD) of JENVAC�® will be Administered by Intramuscular (IM) route.
Control Intervention1: NA: NA
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy infants between �9 months to 12 months (for step 1); and �8 to 10 months of age (for step II) at the time of enrolment. 2 Subject parents or legally acceptable representative is willing to provide signed informed consent. 3 Subjects parents OR LAR intend to remain in the area with the subject during the study period and be available for follow up
Exclusion criteria
Exclusion criteria: 1 Acute medical illness with or without fever within the last 72 hours or an axillary temperature of 38.1 degree C to 39 degree C at the time of screening. 2 History of documented suspected encephalitis, encephalopathy or meningitis 3 Received any JE or MMR vaccine prior to screening. 4 History of hypotonic hypo responsiveness following vaccination. 5 History of seizures or febrile seizures or any other neurologic disorder 6 Prior or anticipated receipt of immunoglobulin or other blood products or injected or oral corticosteroids or other immune modulator therapy except for routine vaccines within 6 weeks of administration of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment. 7 History of documented HIV. 8 Known or suspected impairment of immunologic function. 9 Enrolled in another clinical trial involving any therapy the subject should not participate in any clinical trial during the entire study period. 10 Any condition that in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step I Occurrence of immediate adverse events within 30 minutes after administration of vaccine. Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days Occurrence of Serious Adverse Events throughout the study duration Step II To evaluate the proportion of subjects attaining seroconversion 28 days after co-administration of Measles, Mumps, and Rubella (MMR) and JENVACÃ?® vaccine Timepoint: day 7 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Step I: Immunogenicity is measured in terms of GMT and seroconversion rate following a single dose of JENVACÃ?® Step II: Immunogenicity & safety: To evaluate the antibody titer and seroconversion of anti-JE and MMR antibodies after co-administration of JENVACÃ?® and MMR vaccine at 9 months. Occurrence of immediate adverse events within 30 minutes, solicited AEs within 7 days, and unsolicited AEs within 28 days and SAEs throughout the study. Timepoint: day 28 and 56 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech International Limited
Outcome results
None listed