PMID- 24135573
OWN - NLM
STAT- MEDLINE
DCOM- 20140602
LR  - 20131119
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 31
IP  - 49
DP  - 2013 Dec 2
TI  - Safety and immunogenicity of a tetravalent dengue vaccine in healthy children 
      aged 2-11 years in Malaysia: a randomized, placebo-controlled, Phase III study.
PG  - 5814-21
LID - S0264-410X(13)01365-0 [pii]
LID - 10.1016/j.vaccine.2013.10.013 [doi]
AB  - BACKGROUND: Dengue disease is a major public health problem across the 
      Asia-Pacific region for which there is no licensed vaccine or treatment. We 
      evaluated the safety and immunogenicity of Phase III lots of a candidate vaccine 
      (CYD-TDV) in children in Malaysia. METHODS: In this observer-blind, 
      placebo-controlled, Phase III study, children aged 2-11 years were randomized 
      (4:1) to receive CYD-TDV or placebo at 0, 6 and 12 months. Primary endpoints 
      included assessment of reactogenicity following each dose, adverse events (AEs) 
      and serious AEs (SAEs) reported throughout the study, and immunogenicity 
      expressed as geometric mean titres (GMTs) and distribution of dengue virus (DENV) 
      neutralizing antibody titres. RESULTS: 250 participants enrolled in the study 
      (CYD-TDV: n=199; placebo: n=51). There was a trend for reactogenicity to be 
      higher with CYD-TDV than with placebo post-dose 1 (75.4% versus 68.6%) and 
      post-dose 2 (71.6% versus 62.0%) and slightly lower post-dose 3 (57.9% versus 
      64.0%). Unsolicited AEs declined in frequency with each subsequent dose and were 
      similar overall between groups (CYD-TDV: 53.8%; placebo: 49.0%). Most AEs were of 
      Grade 1 intensity and were transient. SAEs were reported by 5.5% and 11.8% of 
      participants in the CYD-TDV and placebo groups, respectively. No deaths were 
      reported. Baseline seropositivity against each of the four DENV serotypes was 
      similar between groups, ranging from 24.0% (DENV-4) to 36.7% (DENV-3). In the 
      CYD-TDV group, GMTs increased post-dose 2 for all serotypes compared with 
      baseline, ranging from 4.8 (DENV-1) to 8.1-fold (DENV-3). GMTs further increased 
      post-dose 3 for DENV-1 and DENV-2. Compared with baseline, individual titre 
      increases ranged from 6.1-fold (DENV-1) to 7.96-fold (DENV-3). CONCLUSIONS: This 
      study demonstrated a satisfactory safety profile and a balanced humoral immune 
      response against all four DENV serotypes for CYD-TDV administered via a 
      three-dose regimen to children in Malaysia.
CI  - Copyright (c) 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Hss, Amar-Singh
AU  - Hss AS
AD  - Department of Pediatrics, Hospital Raja Permaisuri Bainun, Jalan Hospital, Ipoh, 
      Perak, Malaysia. Electronic address: amarhss@gmail.com.
FAU - Koh, Mia-Tuang
AU  - Koh MT
FAU - Tan, Kah Kee
AU  - Tan KK
FAU - Chan, Lee Gaik
AU  - Chan LG
FAU - Zhou, Lynn
AU  - Zhou L
FAU - Bouckenooghe, Alain
AU  - Bouckenooghe A
FAU - Crevat, Denis
AU  - Crevat D
FAU - Hutagalung, Yanee
AU  - Hutagalung Y
LA  - eng
SI  - ClinicalTrials.gov/NCT01254422
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131014
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Dengue Vaccines)
SB  - IM
MH  - Antibodies, Neutralizing/blood
MH  - Antibodies, Viral/blood
MH  - Child
MH  - Child, Preschool
MH  - Cross Protection
MH  - Dengue/*prevention & control
MH  - Dengue Vaccines/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Immunity, Humoral
MH  - Immunization Schedule
MH  - Malaysia
MH  - Male
MH  - Single-Blind Method
MH  - Vaccination/adverse effects
OTO - NOTNLM
OT  - Immunogenicity
OT  - Malaysia
OT  - Paediatric population
OT  - Safety
OT  - Suggestions dengue
OT  - Vaccine
EDAT- 2013/10/19 06:00
MHDA- 2014/06/03 06:00
CRDT- 2013/10/19 06:00
PHST- 2013/05/17 00:00 [received]
PHST- 2013/08/08 00:00 [revised]
PHST- 2013/10/02 00:00 [accepted]
PHST- 2013/10/19 06:00 [entrez]
PHST- 2013/10/19 06:00 [pubmed]
PHST- 2014/06/03 06:00 [medline]
AID - S0264-410X(13)01365-0 [pii]
AID - 10.1016/j.vaccine.2013.10.013 [doi]
PST - ppublish
SO  - Vaccine. 2013 Dec 2;31(49):5814-21. doi: 10.1016/j.vaccine.2013.10.013. Epub 2013 
      Oct 14.