Safety and immunogenicity of a new formulation of an inactivated hepatitis A vaccine

Ron Dagan, David Greenberg, Polina Goldenbertg-Gehtman, Emmanuel Vidor, Philippe Briantais, Vered Pinsk, Orna Athias, Rafaele Dumas

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25 Scopus citations


The safety and immunogenicity of a new formulation of the inactivated hepatitis A vaccine, Avaxim(TM), was evaluated in 189 children, aged 18 months to 15 years in a monocentric, open trial. Two vaccinations were given six months apart. Enrollment was balanced within three age groups: 18 months to 3 years, 4-8 years and 9-15 years. Antibody titers were measured blindly by an independent laboratory using a modified radioimmunoassay. Two weeks after the first dose, seroconversion was achieved by 94.6, 94.3 and 96.4% of initially HAV-seronegative subjects (antibody titre < 20 mIU/ml) in each age group (youngest to oldest, respectively), with corresponding geometric mean titre concentrations (GMC) of 72.2, 54.3 and 47.1 mIU/ml. Just before the booster dose, the seroconversion rate was 100% in all groups, and the corresponding GMC values were 163, 169 and 111 mIU/ml. All groups included, a 22.6-fold rise in GMC from prebooster levels was observed four weeks after the booster dose. An explanatory analysis suggested a tendency for higher antibody levels in younger children at all vaccination time points. Local reactions were noted in 18.2% of the vaccinees after the first dose and in 8.5% after the booster dose. The rates of systemic reactions were 23.8% after the first dose and 11.4% after the booster dose. Overall, this trial demonstrated the good safety and immunogenicity profile of this vaccine in children aged 18 months to 15 years of age.

Original languageEnglish
Pages (from-to)1919-1925
Number of pages7
Issue number15-16
StatePublished - 9 Apr 1999
Externally publishedYes


  • Children
  • Hepatitis A vaccine
  • Immunogenicity
  • Safety


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