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An open, prospective, randomized study comparing the immunogenicity and safety of two inactivated hepatitis a pediatric vaccines in toddlers, children and adolescents in china.
MedLine Citation:
PMID:  23334341     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
BACKGROUND: : Vaccines against hepatitis A provide long-lasting protection in both adults and children. The aim of this study was to demonstrate that the inactivated hepatitis A vaccine AVAXIM 80U Pediatric is safe and not inferior in terms of seroprotection rate to HAVRIX 720 vaccine 1 month after booster vaccination.
METHODS: : An open, randomized, single-center trial was conducted in China in healthy antihepatitis A virus seronegative individuals from 12 months to 15 years of age. Participants were randomized in a 2:1 ratio to receive either AVAXIM 80U Pediatric or HAVRIX 720, followed by a booster vaccination, using the same vaccine 6 months afterward.
RESULTS: : A total of 720 individuals were included in the study, 480 in the AVAXIM 80U Pediatric group and 240 in the HAVRIX 720 group, and 686 individuals completed the full vaccination schedule. AVAXIM 80U Pediatric was statistically noninferior to HAVRIX 720 in terms of seroprotection rate for all individuals and in each of 3 age groups: toddlers (12-23 months), children (2-11 years) and adolescents (12-15 years). Antihepatitis A virus geometric mean titers were significantly higher with AVAXIM 80U Pediatric than with HAVRIX 720. Both inactivated hepatitis A vaccines were well-tolerated and had a similar incidence and type of adverse events.
CONCLUSION: : AVAXIM 80U Pediatric is safe and immunogenic, with a seroprotection rate that is not inferior to HAVRIX 720 in a pediatric population of healthy individuals.
Authors:
Rong Cheng Li; Yanping Li; Nong Yi; Lirong Huang; Zongju Wan; Yanping Zhang; Anvar Rasuli
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  32     ISSN:  1532-0987     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e77-81     Citation Subset:  IM    
Affiliation:
From the *Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control, Center for Vaccine Clinical Trials, Nanning Guangxi; †National Institutes for Food and Drug Control; ‡Sanofi Pasteur, Beijing, China; and §Sanofi Pasteur, Lyon, France.
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