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Sponsored by: |
Program for Appropriate Technology in Health |
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Information provided by: | Program for Appropriate Technology in Health |
ClinicalTrials.gov Identifier: | NCT00412516 |
The previously conducted JEV01 study looked at the immunogenicity and safety of the concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the one month post vaccination time point. The purpose of the JEV01 study was to help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants who received both vaccines and completed the JEV01 study. This study, however, will provide crucial data to help ensure the long-term immunogenicity of the concurrent administration of these vaccines and provide valuable information to determine the use of these vaccines in routine immunization programs. This study is planned because in the original protocol for JEV01, long-term data points were not included. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24 and 36 months post vaccination) protection against these diseases at the same level as those who receive the vaccines at different intervals.
Condition | Intervention | Phase |
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Encephalitis, Japanese B |
Biological: Live attenuated SA 14-14-2 vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Assessment at 24 Months Post-Vaccination of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine to Measles Vaccine Given Alone |
Estimated Enrollment: | 600 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1
Measles vaccine and and then JE vaccine one month later
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Biological: Live attenuated SA 14-14-2 vaccine
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
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Group 2: Experimental
Measles and JE Vaccine given concurrently
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Biological: Live attenuated SA 14-14-2 vaccine
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
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Group 3
JE and then Measles vaccine one month later
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Biological: Live attenuated SA 14-14-2 vaccine
Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
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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 encephalitis in the world. Approximately 3 billion people—including 700 million children—live in Asian areas at risk for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.
An effective vaccine has existed since 1941, but has not reached the poorest countries in Asia. During the 60 years that the vaccine has been available, JE has infected an estimated 10.5 million children, resulting in more than 3 million deaths and more than 4 million children living with long-term disabilities. Control of this disease has been limited due to poor disease surveillance, a limited and unstable vaccine supply, lack of guidance and programmatic support for immunization, and limited advocacy.
A successful vaccine should be safe, efficacious, affordable, administered in a single dose, and easily incorporated into the routine Expanded Programmes on Immunization (EPI) programs.
This trial is designed to determine the potential interference between the measles vaccine and the Japanese encephalitis vaccine at 12, 24, and 36 months post-vaccination. As these vaccines will be used in routine EPI systems at the same time, similar to how measles and yellow fever vaccine (also a Flavivirus) are administered, it is imperative to collect long-term data showing that neither vaccine interferes with seroconversion of the other when co-administered.This information will help to ensure subject safety and facilitate programmatic efficiency, reducing the number of immunization visits for both parents and health care workers.
Ages Eligible for Study: | 20 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Philippines | |
Research Institute for Tropical Medicine (RITM) | |
Manila, Philippines |
Principal Investigator: | Salvacion Gatchalian, MD | Research Institute for Tropical Medicine (RITM) |
Responsible Party: | PATH ( PATH ) |
Study ID Numbers: | JEV02 |
Study First Received: | December 14, 2006 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00412516 |
Health Authority: | Philippines: Bureau of Food and Drugs |
Japanese Encephalitis Japanese B Encephalitis Japanese B Viral Encephalitis Viral Encephalitis, Japanese B |
Virus Diseases Japanese encephalitis Central Nervous System Infections Measles Central Nervous System Diseases |
Encephalitis, Japanese Arbovirus Infections Brain Diseases Encephalitis |
RNA Virus Infections Flaviviridae Infections Flavivirus Infections Encephalitis, Viral |
Encephalitis, Arbovirus Nervous System Diseases Central Nervous System Viral Diseases |