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

Phase 3 Completed 600 enrolled PATH Mahidol University · collab Quintiles, Inc. · collab Research Institute for Tropical Medicine, Manila, Philippines · collab

RandomizedParallel-groupOpen-labelPrevention

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, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.

Timeline

Start: 2005-11-21
Primary completion: 2006-05-30
Completion: 2006-05-30

Outcome

Met primary endpoint

paper rates in the combined MV-LJEV (Group 2) were not statistically inferior to those in Group 3 receiving MV separately (96% versus 100%, respectively). PMID 18394765 ↗

Publications

Results Gatchalian S, Yao Y, Zhou B, Zhang L, Yoksan S, Kelly K, Neuzil KM, Yaich M, Jacobson J. Comparison of the immunogenicity and safety of measles vaccine administered alone or with live, attenuated Japanese encephalitis SA 14-14-2 vaccine in Philippine infants. Vaccine. 2008 Apr 24;26(18):2234-41. doi: 10.1016/j.vaccine.2008.02.042. Epub 2008 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Live Japanese encephalitis vaccine SA 14-14-2	Vaccine	0.5 ml	Subcutaneous
Subject	Measles vaccine	Vaccine	0.5 ml	Subcutaneous