Status:
COMPLETED
Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Lead Sponsor:
PATH
Collaborating Sponsors:
Research Institute for Tropical Medicine, Manila, Philippines
Quintiles, Inc.
Conditions:
Encephalitis, Japanese B
Eligibility:
All Genders
8-11 years
Phase:
PHASE3
Brief Summary
This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, i...
Detailed Description
Japanese encephalitis is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral ...
Eligibility Criteria
Inclusion
- Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit
- Subject is a full-term infant
- Subject's parents or legal guardian willing to provide signed informed consent.
- Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV).
Exclusion
- History of documented HIV.
- Known or suspected impairment of immunologic function.
- History of serious chronic disease
- Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5°C at the time of inclusion.
- History of documented suspected encephalitis, encephalopathy, or meningitis
- History of measles
- History of thrombocytopenic purpura.
- Received any JE or measles vaccine prior to enrollment.
- Received any vaccine, other than the study vaccines, within 2 weeks prior to or scheduled to receive a non-study vaccination during the conduct of this trial.
- Hypotonic - hyporesponsiveness, after the preceding vaccination.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- 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 the study vaccines. 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 enrollment.
- Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
- Serious adverse event related to the vaccine (i.e., possible, probably, definite)
- Persistent inconsolable crying (\>3 hours) observed after a previous dose.
- Unable to attend the scheduled visits or comply with the study procedures.
- Enrolled in another clinical trial involving any therapy.
- 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 :
November 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2006
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00249769
Start Date
November 21 2005
End Date
May 30 2006
Last Update
March 10 2020
Active Locations (1)
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1
Research Institute for Tropical Medicine
Manila, Philippines