Korean J Pediatr Infect Dis.  2008 Dec;15(2):115-120. 10.14776/kjpid.2008.15.2.115.

Post-Marketing Surveillance Study of Hepatitis A Vaccine in Korean Population

• Choi JW
• Kim MS
• Ma SH
• Kang JH
• Ok JJ
• Ng TL
• Bock HL
• Havrixâ„¢ PMS Korean study group

• KMID: 2439921
• DOI: http://doi.org/10.14776/kjpid.2008.15.2.115

Abstract

PURPOSE
This post-marketing surveillance (PMS) study was conducted in Korea to assess the safety and reactogenicity of hepatitis A vaccine (GlaxoSmithKlineBiologicals'Havrixâ„¢) administered to the Korean population.
METHODS
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.
RESULTS
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.
CONCLUSION
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.

Keyword

Hepatitis A vaccine; Diary cards; Post-marketing surveillance

MeSH Terms

Follow-Up Studies
Healthy Volunteers
Hepatitis A Vaccines*
Hepatitis A*
Hepatitis*
Humans
Korea
Parents
Hepatitis A Vaccines