Please use this identifier to cite or link to this item: https://ir.swu.ac.th/jspui/handle/123456789/13164
ชื่อเรื่อง: Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand
ผู้แต่ง: Chotpitayasunondh T.
Pruekprasert P.
Puthanakit T.
Pancharoen C.
Tangsathapornpong A.
Oberdorfer P.
Kosalaraksa P.
Prommalikit O.
Tangkittithaworn S.
Kerdpanich P.
Techasaensiri C.
Korejwo J.
Chuenkitmongkol S.
Houillon G.
Keywords: Japanese encephalitis vaccine
live vaccine
recombinant vaccine
Japanese encephalitis vaccine
live vaccine
recombinant vaccine
acute disseminated encephalomyelitis
allergic reaction
anaphylaxis
Article
Bell palsy
brain disease
bronchitis
child
child hospitalization
congenital malformation
convulsion
death
dengue
diarrhea
disability
drug marketing
drug safety
dyspepsia
encephalitis
enteritis
epilepsy
febrile convulsion
female
fever
food poisoning
gastritis
gastroenteritis
human
infant
influenza
Japanese encephalitis
licensing
male
mouth ulcer
multicenter study
myelitis
neurologic disease
normal human
open study
peripheral neuropathy
pharyngitis
phase 4 clinical trial
pneumonia
preschool child
priority journal
prospective study
pyrexia idiopathica
rhinopharyngitis
side effect
single drug dose
Thailand
urticaria
vaccination
vaccination reaction
vaccine failure
viremia
virus infection
virus pneumonia
adverse drug reaction
clinical trial
Japanese encephalitis
pathology
Child, Preschool
Drug-Related Side Effects and Adverse Reactions
Encephalitis, Japanese
Female
Healthy Volunteers
Humans
Infant
Japanese Encephalitis Vaccines
Male
Prospective Studies
Thailand
Vaccines, Attenuated
Vaccines, Synthetic
วันที่เผยแพร่: 2017
บทคัดย่อ: 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). © 2016 The Authors
URI: https://ir.swu.ac.th/jspui/handle/123456789/13164
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85006966243&doi=10.1016%2fj.vaccine.2016.11.062&partnerID=40&md5=5f84f81d084334af01bfa9bd6bb01e7b
ISSN: 0264410X
Appears in Collections:Scopus 1983-2021

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