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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/41980
Title: Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand
Authors: 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
Queen Sirikit National Institute of Child Health
Prince of Songkla University
Chulalongkorn University
Faculty of Medicine, Thammasat University
Chiang Mai University
Srinagarind hospital
Srinakharinwirot University
Phramongkutklao College of Medicine
Mahidol University
Sanofi Pasteur SA
Sanofi Pasteur
Keywords: Biochemistry, Genetics and Molecular Biology
Issue Date: 5-Jan-2017
Citation: Vaccine. Vol.35, No.2 (2017), 299-304
Abstract: © 2016 The Authors 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 <5 years in Thailand as a primary (Group 1) or booster (Group 2) vaccination. Serious AEs (SAEs), including AEs of special interest, up to 60 days after administration were evaluated. Immediate Grade 3 systemic AEs up to 30 min after JE-CV administration were also described. 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 www.clinicaltrials.gov (NCT01981967; Universal Trial Number: U1111-1127-7052).
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85006966243&origin=inward
http://repository.li.mahidol.ac.th/dspace/handle/123456789/41980
ISSN: 18732518
0264410X
Appears in Collections:Scopus 2016-2017

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