Vaccine – Volume 35, Issue 2, Pages 201-410 (5 January 2017)

Vaccine
Volume 35, Issue 2, Pages 201-410 (5 January 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/2

Original Research Article

Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand
Original Research Article
Pages 299-304
Tawee Chotpitayasunondh, Pornpimol Pruekprasert, Thanyawee Puthanakit, Chitsanu Pancharoen, Auchara Tangsathapornpong, Peninnah Oberdorfer, Pope Kosalaraksa, Olarn Prommalikit, Suwimon Tangkittithaworn, Phirangkul Kerdpanich, Chonnamet Techasaensiri, Joanna Korejwo, Sunate Chuenkitmongkol, Guy Houillon
Abstract
Background
Japanese encephalitis is a mosquito-borne viral disease endemic in most countries in Asia. A recombinant live, attenuated Japanese encephalitis virus vaccine, JE-CV, is licensed in 14 countries, including Thailand, for the prevention of Japanese encephalitis in adults and children.
Methods
This was a prospective, phase IV, open-label, multicentre, safety study of JE-CV conducted from November 2013 to April 2015, to evaluate rare serious adverse events (AEs). JE-CV was administered to 10,000 healthy children aged 9 months to Results
The median age of participants was 1.1 years in Group 1 and 3.8 years in Group 2. SAEs were reported in 204 (3.0%) participants in Group 1 and 59 (1.9%) participants in Group 2. Among a total of 294 SAEs in 263 participants, only three events occurring in two participants were considered related to vaccination. All three cases were moderate urticaria, none of which met the definition of AEs of special interest for hypersensitivity. AEs of special interest were reported in 28 (0.4%) participants in Group 1 and 4 (0.1%) participants in Group 2; none were considered related to vaccination. Febrile convulsion was the most frequently reported AE of special interest: 25 (0.4%) participants in Group 1; and 2 (<0.1%) in Group 2. There were no cases of Japanese encephalitis reported. No Grade 3 immediate systemic AEs were reported after any JE-CV vaccination.
Conclusions
Our study did not identify any new safety concerns with JE-CV and confirms its good safety profile.
This study was registered on http://www.clinicaltrials.gov (NCT01981967; Universal Trial Number: U1111-1127-7052)