PMID- 27903416 OWN - NLM STAT- MEDLINE DCOM- 20171215 LR - 20180206 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 35 IP - 2 DP - 2017 Jan 5 TI - Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand. PG - 299-304 LID - S0264-410X(16)31133-1 [pii] LID - 10.1016/j.vaccine.2016.11.062 [doi] AB - 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 9months to <5years in Thailand as a primary (Group 1) or booster (Group 2) vaccination. Serious AEs (SAEs), including AEs of special interest, up to 60days after administration were evaluated. Immediate Grade 3 systemic AEs up to 30min after JE-CV administration were also described. RESULTS: The median age of participants was 1.1years in Group 1 and 3.8years 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). CI - Copyright (c) 2016 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Chotpitayasunondh, Tawee AU - Chotpitayasunondh T AD - Queen Sirikit National Institute of Child Health (Children's Hospital), Bangkok, Thailand. FAU - Pruekprasert, Pornpimol AU - Pruekprasert P AD - Department of Pediatrics, Faculty of Medicine, Songklanagarind Hospital, Prince of Songkla University, Songkhla, Thailand. FAU - Puthanakit, Thanyawee AU - Puthanakit T AD - Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Bangkok, Thailand. FAU - Pancharoen, Chitsanu AU - Pancharoen C AD - Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand. FAU - Tangsathapornpong, Auchara AU - Tangsathapornpong A AD - Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathumthani, Thailand. FAU - Oberdorfer, Peninnah AU - Oberdorfer P AD - Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. FAU - Kosalaraksa, Pope AU - Kosalaraksa P AD - Department of Pediatrics, Faculty of Medicine, Srinagarind Hospital, Khon Kaen, Thailand. Electronic address: pkosalaraksa@yahoo.com. FAU - Prommalikit, Olarn AU - Prommalikit O AD - HRH Princess Maha Chakri Sirindhorn Medical Center, Srinakharinwirot University, Nakornnayok, Thailand. FAU - Tangkittithaworn, Suwimon AU - Tangkittithaworn S AD - Department of Pediatrics, Chonprathan Hospital, Srinakharinwirot University, Nonthaburi, Thailand. FAU - Kerdpanich, Phirangkul AU - Kerdpanich P AD - Division of Infectious Diseases, Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand. FAU - Techasaensiri, Chonnamet AU - Techasaensiri C AD - Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. FAU - Korejwo, Joanna AU - Korejwo J AD - Sanofi Pasteur, Lyon, France. FAU - Chuenkitmongkol, Sunate AU - Chuenkitmongkol S AD - Sanofi Pasteur, Bangkok, Thailand. FAU - Houillon, Guy AU - Houillon G AD - Sanofi Pasteur, Lyon, France. LA - eng SI - ClinicalTrials.gov/NCT01981967 PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20161128 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Japanese Encephalitis Vaccines) RN - 0 (Vaccines, Attenuated) RN - 0 (Vaccines, Synthetic) SB - IM MH - Child, Preschool MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology MH - Encephalitis, Japanese/*prevention & control MH - Female MH - Healthy Volunteers MH - Humans MH - Infant MH - Japanese Encephalitis Vaccines/administration & dosage/*adverse effects MH - Male MH - Prospective Studies MH - Thailand MH - Vaccines, Attenuated/administration & dosage/adverse effects MH - Vaccines, Synthetic/administration & dosage/adverse effects OTO - NOTNLM OT - Booster OT - JE-CV OT - Japanese encephalitis OT - Primary OT - Safety OT - Vaccine EDAT- 2016/12/03 06:00 MHDA- 2017/12/16 06:00 CRDT- 2016/12/02 06:00 PHST- 2016/09/14 00:00 [received] PHST- 2016/11/16 00:00 [revised] PHST- 2016/11/17 00:00 [accepted] PHST- 2016/12/03 06:00 [pubmed] PHST- 2017/12/16 06:00 [medline] PHST- 2016/12/02 06:00 [entrez] AID - S0264-410X(16)31133-1 [pii] AID - 10.1016/j.vaccine.2016.11.062 [doi] PST - ppublish SO - Vaccine. 2017 Jan 5;35(2):299-304. doi: 10.1016/j.vaccine.2016.11.062. Epub 2016 Nov 28.