PMID- 30403910
OWN - NLM
STAT- MEDLINE
DCOM- 20200226
LR  - 20200309
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 15
IP  - 3
DP  - 2019
TI  - Safety of two doses of an inactivated hepatitis a vaccine given 6 months apart in 
      healthy toddlers, children, and adolescents aged 12 months to 15 years in China: 
      a phase IV study.
PG  - 748-754
LID - 10.1080/21645515.2018.1539600 [doi]
AB  - Hepatitis A is a vaccine-preventable infection caused by the HA virus (HAV) with 
      transitional to intermediate endemicity in China. An inactivated vaccine first 
      licensed in China in 2010 (Avaxim(R) 80U Pediatric) is indicated for primary and 
      booster vaccination in children from 12 months to 15 years of age. This Phase IV, 
      open-label, single-arm trial supported licensure in pediatric age groups in 
      China. A total of 355 healthy infants and toddlers (< 2 years of age), children 
      (2 to 11 years of age), and adolescents (>/= 12 years of age) were enrolled to 
      receive two doses of intramuscular HA vaccine, separated by 6 months. 
      Participants were split into Group 1 (infants and toddlers: N = 270) and Group 2 
      (children and adolescents: N = 85). Safety was assessed by solicited injection 
      site and systemic adverse events (AEs) for 7 days and unsolicited AEs for 30 days 
      after each vaccination. Serious AEs (SAEs) were collected throughout. 
      Immunogenicity was not assessed. Analyses were descriptive. Both vaccinations 
      were very well tolerated in each group. The incidence of solicited injection site 
      reactions was lower in Group 1 (17.9%) than Group 2 (33.3%) and for solicited 
      systemic reactions was similar for each group. The incidence of unsolicited AEs 
      in Group 1 was 6.3% and none in Group 2. For solicited and unsolicited AEs the 
      incidence was slightly higher after the first vaccination. There were no SAEs. 
      Overall, the good safety profile of this pediatric HA vaccine was confirmed in 
      infants, toddlers, children, and adolescents aged 12 months to 15 years in China.
FAU - Shi, Nianmin
AU  - Shi N
AD  - a Beijing Chaoyang District Center for Disease Control and Prevention , Beijing , 
      China.
FAU - Rasuli, Anvar
AU  - Rasuli A
AD  - b Global Medical Affairs , Sanofi Pasteur , Lyon , France.
FAU - Thollot, Yael
AU  - Thollot Y
AD  - b Global Medical Affairs , Sanofi Pasteur , Lyon , France.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20181205
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - China
MH  - Female
MH  - Hepatitis A/*prevention & control
MH  - Hepatitis A Vaccines/*administration & dosage/adverse effects
MH  - Humans
MH  - *Immunization Schedule
MH  - Immunization, Secondary
MH  - Infant
MH  - Injections, Intramuscular
MH  - Male
MH  - Vaccines, Inactivated/administration & dosage/adverse effects
PMC - PMC6605741
OTO - NOTNLM
OT  - China
OT  - hepatitis A
OT  - inactivated vaccine
OT  - pediatric
OT  - safety
EDAT- 2018/11/08 06:00
MHDA- 2020/02/27 06:00
PMCR- 2018/12/05
CRDT- 2018/11/08 06:00
PHST- 2018/11/08 06:00 [pubmed]
PHST- 2020/02/27 06:00 [medline]
PHST- 2018/11/08 06:00 [entrez]
PHST- 2018/12/05 00:00 [pmc-release]
AID - 1539600 [pii]
AID - 10.1080/21645515.2018.1539600 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2019;15(3):748-754. doi: 10.1080/21645515.2018.1539600. 
      Epub 2018 Dec 5.