PMID- 30732169
OWN - NLM
STAT- MEDLINE
DCOM- 20190226
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 98
IP  - 6
DP  - 2019 Feb
TI  - Comparison of the immunogenicity and safety of 3 inactivated hepatitis A vaccines 
      in Korean children aged 12 to 18 months: An open-label, randomized, prospective, 
      multicenter study.
PG  - e14364
LID - 10.1097/MD.0000000000014364 [doi]
LID - e14364
AB  - Several approved inactivated hepatitis A (HA) vaccines are available in Korea. 
      These have been shown to be immunogenic and safe in European children; however, 
      their immunogenicity and safety have not been investigated among Korean children. 
      We aimed to compare the immunogenicity and safety of the most commonly used HA 
      vaccines in ethnic Korean children aged 12 to 18 months.In this open-label, 
      randomized, prospective, multicenter study, 108 children were enrolled and 
      randomized to receive a pediatric form of Avaxim, Epaxal, or Havrix. The 2nd dose 
      was administered after an interval of 6 months. Anti-HA virus (HAV) 
      immunoglobulin (Ig) G was measured to assess geometric mean concentrations (GMCs) 
      and seropositvity rates (>/=20 mIU/mL anti-HAV IgG). To assess safety, local 
      solicited adverse events (AEs), systemic solicited AEs, unsolicited AEs, and 
      serious AEs (SAEs) were graded.Among the 108 participants enrolled, 37, 34, and 
      37 received Avaxim, Epaxal, and Havrix, respectively. After administration of 2 
      doses, the seropositivity rates in the Avaxim, Epaxal, and Havrix groups were all 
      100% (95% confidence intervals [CIs]: 99.0-100, 98.9-100, and 99.0-100, 
      respectively; P < .001). The anti-HAV GMCs in the Avaxim, Epaxal, and Havrix 
      groups were 5868.4 (95% CI: 4237.2-8126.6), 1962.1 (95% CI: 1298.0-2965.9), and 
      2232.9 mIU/mL (95% CI: 1428.4-3490.4), respectively, after administration of 2 
      doses (P < .001). There were no significant differences in the proportions of 
      participants reporting local solicited AEs, systemic solicited AEs, unsolicited 
      AEs, and SAEs among the 3 vaccine groups after the 1st and 2nd doses. All local 
      solicited and unsolicited AEs were grade 1 or 2. Grade 3 systemic solicited AE 
      occurred in 5.4% and 2.9% of the participants in the Havrix group after the 1st 
      and 2nd doses, respectively. SAEs after the 1st and 2nd doses were reported in 2 
      participants and 1 participant, respectively, but none was assessed as being 
      related to vaccination.The results indicate that these vaccines were safe and 
      immunogenic in ethnic Korean children. The results have contributed to the 
      establishing of an HA vaccination policy in Korea and will be informative to 
      countries that plan to initiate vaccination programs against HAV.
FAU - Hong, Seung Soo
AU  - Hong SS
AD  - Department of Pediatrics, Graduate School of Medical Science.
FAU - Choi, Ui Yoon
AU  - Choi UY
AD  - Department of Pediatrics, College of Medicine, The Catholic University of Korea, 
      Seoul.
FAU - Ma, Sang Hyuk
AU  - Ma SH
AD  - Department of Pediatrics, Changwon Fatima Hospital, Changwon.
FAU - Lee, Soo Young
AU  - Lee SY
AD  - Department of Pediatrics, College of Medicine, The Catholic University of Korea, 
      Seoul.
FAU - Han, Seung Beom
AU  - Han SB
AD  - Department of Pediatrics, College of Medicine, The Catholic University of Korea, 
      Seoul.
FAU - Kim, Kyung-Hyo
AU  - Kim KH
AD  - Department of Pediatrics, Ewha Womans University School of Medicine, Seoul, 
      Republic of Korea.
FAU - Kang, Jin Han
AU  - Kang JH
AD  - Department of Pediatrics, College of Medicine, The Catholic University of Korea, 
      Seoul.
FAU - Kim, Jong-Hyun
AU  - Kim JH
AD  - Department of Pediatrics, College of Medicine, The Catholic University of Korea, 
      Seoul.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Female
MH  - Hepatitis A Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Humans
MH  - Infant
MH  - Male
MH  - Prospective Studies
MH  - Republic of Korea
MH  - Vaccines, Inactivated/administration & dosage/*adverse effects/*immunology
PMC - PMC6380807
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2019/02/09 06:00
MHDA- 2019/02/27 06:00
PMCR- 2019/02/08
CRDT- 2019/02/09 06:00
PHST- 2019/02/09 06:00 [entrez]
PHST- 2019/02/09 06:00 [pubmed]
PHST- 2019/02/27 06:00 [medline]
PHST- 2019/02/08 00:00 [pmc-release]
AID - 00005792-201902080-00050 [pii]
AID - MD-D-18-06357 [pii]
AID - 10.1097/MD.0000000000014364 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2019 Feb;98(6):e14364. doi: 10.1097/MD.0000000000014364.