Status:
COMPLETED
Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age
Lead Sponsor:
PATH
Collaborating Sponsors:
Ministry of Health of Sri Lanka
Mahidol University
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
9-9 years
Phase:
PHASE4
Brief Summary
To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-ad...
Detailed Description
JE virus is an arbovirus that causes a devastating neurological disease resulting in high rates of mortality orneurologic sequelae. The severity of sequelae, together with the volume of cases, makes J...
Eligibility Criteria
Inclusion
- Healthy child 9 months (±2 weeks) of age at the enrollment visit.
- Subject was a full-term infant.
- Subject's parent or legal guardian is literate and willing to provide written informed consent.
- Subject is up-to-date for all vaccinations recommended in the Sri Lankan childhood immunization schedule.
Exclusion
- Enrolled in another clinical trial involving any therapy.
- Subject and/or parent(s) or guardian(s) are unable to attend the scheduled visits or comply with the study procedures.
- Received any non-study vaccine within 2 weeks prior to enrolment or refusal to postpone receipt of such vaccines until 28 days after study entry.
- Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy except routine vaccines within 6 weeks of administration of study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \<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.
- History of documented or suspected encephalitis, encephalopathy, or meningitis.
- History of measles.
- History of Japanese encephalitis.
- Serious adverse event related (i.e., possible, probably, definite) to previous receipt of any JE vaccine, if applicable.
- Persistent inconsolable crying (\>3 hours) observed after previous receipt of any JE vaccine, if applicable.
- Hypotonic - hyporesponsiveness after past receipt of any JE vaccine, if applicable.
- Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
- History of serious chronic disease (cardiac, renal, neurologic, metabolic, or rheumatologic).
- Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- History of thrombocytopenic purpura.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- Known or suspected immunologic function impairment of any kind and/or known HIV infection.
- Parent with known or suspected immunologic function impairment of any kind and/or known HIV infection.
- 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.
Key Trial Info
Start Date :
July 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2008
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00463684
Start Date
July 7 2007
End Date
October 6 2008
Last Update
February 8 2019
Active Locations (3)
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1
Homagama MOH Division Medical Office
Homagama, District of Colombo, Sri Lanka
2
Kolonnawa MOH Division Medical Office
Kolonnawa, District of Colombo, Sri Lanka
3
Moratuwa MOH Division Medical Office
Moratuwa, District of Colombo, Sri Lanka