Avaxim® 80U pediatric vaccine administered as a 2-dose schedule 6 months apart for the prevention of hepatitis A is safe for children age 12 months to 15 years, according to a phase 4, open-label, single-arm study published in Human Vaccines & Immunotherapeutics.1
China is an area of intermediate hepatitis A endemicity,2,3 therefore, Avaxim® 80U pediatric vaccine was first licensed in China in 2010. However, it was not marketed in that country, and therefore there are no postmarketing data available.1 National recommendations in China require that postmarketing safety data be submitted to support the renewal of the license; thus, researchers conducted a safety trial of the vaccine in 269 healthy infants and toddlers (<2 years of age) and 84 children (2-11 years of age) and adolescents (12-15 years of age). The vaccine was administered intramuscularly in 2 doses separated by 6 months.
The researchers found the vaccine to be well tolerated. The incidence of solicited injection-site reactions was lower in infants and toddlers (17.2%) compared with children and adolescents (33.3%). However, solicited systemic reactions were similar for each group. The incidence of unsolicited adverse events was 6.3% in infants and toddlers and there were no reports of adverse events in children or adolescents.
Interestingly, the incidence of solicited and unsolicited adverse events was slightly higher after the first vaccination. There were no reports of serious adverse events. These results were consistent with those of previous clinical trials.4-6
“Overall, this study confirmed the good safety profile of the Avaxim® 80U pediatric vaccine, administered in a 2-dose schedule 6 months apart to infants, toddlers, children, and adolescents aged 12 months to 15 years in China, supporting its continued licensure,” concluded the authors.1
Disclosure: This study was supported by Sanofi Pasteur.
- Shi N, Rasuli A, Thollot Y. 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 [published online November 7, 2018]. Hum Vaccin Immunother. doi: 10.1080/21645515.2018.1539600
- Jacobsen KH, Wiersma ST. Hepatitis A virus seroprevalence by age and world region, 1990 and 2005. Vaccine. 2010;28(41):6653-6657.
- Mohd Hanafiah K, Jacobsen KH, Wiersma ST. Challenges to mapping the health risk of hepatitis A virus infection. Int J Health Geogr. 2011;10:57.
- Abarca K, Ibánez I, Perret C, Vial P, Zinsou J-A. Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children. Int J Infect Dis. 2008;12(3):270-277.
- Dagan R, Greenberg D, Goldenbertg-Gehtman P, et al. Safety and immunogenicity of a new formulation of an inactivated hepatitis A vaccine. Vaccine. 1999;17(15-16):1919-1925.
- López EL, Del Carmen Xifró M, Torrado LE, et al. Safety and immunogenicity of a pediatric formulation of inactivated hepatitis A vaccine in Argentinean children. Pediatr Infect Dis J. 2001;20(1):48-52.