Publication:
Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand

0
0

Issued Date

2017

Resource Type

Article

File Type

application/pdf

ISSN

0264410X

DOI

10.1016/j.vaccine.2016.11.062

Other identifier(s)

2-s2.0-85006966243

Rights Holder(s)

Scopus

Bibliographic Citation

Vaccine. Vol 35, No.2 (2017), p.299-304

Suggested Citation

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. Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand. Vaccine. Vol 35, No.2 (2017), p.299-304. doi:10.1016/j.vaccine.2016.11.062 Retrieved from: https://hdl.handle.net/20.500.14740/4276

Title

Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand

Author(s)

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.

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 <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

Subject(s)

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

View online Resources

Research Projects

Organizational Units

Journal Issue

URI

https://hdl.handle.net/20.500.14740/4276

Collections

Scopus: Year 1983-2021

Endorsement

Review

Supplemented By

Referenced By