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Vaccine. 2017 Jan 5;35(2):299-304. doi: 10.1016/j.vaccine.2016.11.062. Epub 2016 Nov 28.

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

Author information

1
Queen Sirikit National Institute of Child Health (Children's Hospital), Bangkok, Thailand.
2
Department of Pediatrics, Faculty of Medicine, Songklanagarind Hospital, Prince of Songkla University, Songkhla, Thailand.
3
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.
4
Department of Pediatrics, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.
5
Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathumthani, Thailand.
6
Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
7
Department of Pediatrics, Faculty of Medicine, Srinagarind Hospital, Khon Kaen, Thailand. Electronic address: pkosalaraksa@yahoo.com.
8
HRH Princess Maha Chakri Sirindhorn Medical Center, Srinakharinwirot University, Nakornnayok, Thailand.
9
Department of Pediatrics, Chonprathan Hospital, Srinakharinwirot University, Nonthaburi, Thailand.
10
Division of Infectious Diseases, Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
11
Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
12
Sanofi Pasteur, Lyon, France.
13
Sanofi Pasteur, Bangkok, Thailand.

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 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).

KEYWORDS:

Booster; JE-CV; Japanese encephalitis; Primary; Safety; Vaccine

PMID:
27903416
DOI:
10.1016/j.vaccine.2016.11.062
[Indexed for MEDLINE]
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