Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine

PHASE3CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

November 21, 2005

Primary Completion Date

May 30, 2006

Study Completion Date

May 30, 2006

Conditions
Encephalitis, Japanese B
Interventions
BIOLOGICAL

Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)

Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.

BIOLOGICAL

Measles Vaccine (MV)

"The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO).~SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979."

Trial Locations (1)

Unknown

Research Institute for Tropical Medicine, Manila

All Listed Sponsors
collaborator

Research Institute for Tropical Medicine, Manila, Philippines

UNKNOWN

collaborator

Quintiles, Inc.

INDUSTRY

collaborator

Mahidol University

OTHER

lead

PATH

OTHER

NCT00249769 - Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine | Biotech Hunter | Biotech Hunter