This post-marketing surveillance (PMS) study was conducted in Korea to assess the safety and reactogenicity of hepatitis A vaccine (GlaxoSmithKlineBiologicals'Havrix™) administered to the Korean population.

A total of 1,188 healthy subjects with 1,122 subjects <6 years of age were enrolled to receive one dose of the hepatitis A vaccine from April 2005 to January 2006. Diary cards were provided to the subjects or subjects' parents for reporting solicited and unsolicited symptoms during the 4-day and 31-day post-vaccination follow-up period.

The number of subjects who returned diary cards was 568, whereas, 620 subjects did not return diary cards. Among the subjects who returned diary cards, 9.9% and 14.3% reported local and general solicited/unsolicited symptoms. Among the subjects who did not return diary cards, 1.6% and 8.4% reported local and general solicited/unsolicited symptoms. At least one unsolicited symptom was reported by 13.2% of the subjects.

Results indicate that the vaccine was well-tolerated and had an acceptable safety profile. The use of diary cards in such a survey provided a prompt and reliable option for recording symptoms.