Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463684
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2007-04-18
Brief Title:
Live Attenuated Japanese Encephalitis JE Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age
Sponsor:
PATH
Organization:
PATH
Study Overview
Official Title:
Assessment of the Immunogenicity and Safety of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine in Children in Sri Lanka
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JEV03
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-administration of LJEV and measles vaccine at 9 months of age The primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese Encephalitis JE and measles concomitantly vaccinated subjects 9 months of age is greater than 80 for JE and greater than 90 for measles
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 JE an important cause of encephalitis The disease is endemic across temperate and tropical zones of Asiaand because of its zoonotic cycle eradicating JE from the environment is unrealistic Universal childhood vaccination is essential for disease control In Sri Lanka immunization against JE began in 1988 By 2006 two types of JE vaccines were available for use in Sri Lanka-inactivated mouse brain-derived vaccine and live attenuated SA-14-14-2 JE vaccine LJEV Only the inactivated vaccine was being used in the countrys public-sector immunization program Concern in Japan over a rare but potentially dangerous adverse event associated with a mouse brain-derived vaccine led the manufacturer in Japan to discontinue production in 2005 thus limiting global supply of inactivated JE vaccines and raising costs for remaining inactivated vaccines In August of 2006 the World Health Organization stated in its position paper on Japanese encephalitis vaccines that the mouse brain-derived vaccine should be replaced by a new generation of JE vaccines For Sri Lanka switching to the less expensive LJEV was estimated in 2006 to save the National Immunization Programme NIP between US86 and 89 million annually in direct vaccine costs alone To generate local immunogenicity and safety data to guide policy for potential use of LJEV in Sri Lankas NIP the Ministry of Healthcare and Nutrition in cooperation with PATH initiated the study The study was conducted in three peri-urban health divisions of low JE endemicity in the District of Colombo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None