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| |  Coadministration of Quadrivalent HPV Vaccine and Hepatitis A/B Vaccine in Girls Safe, Well Tolerated: Presented at IPV By Bruce Sylvester MALMO, Sweden -- May 15, 2009 -- Concomitant administration of human papillomavirus (HPV) quadrivalent vaccine (Gardasil) and hepatitis A (HepA) inactivated/hepatitis B (HepB) recombinant vaccine (Twinrix) is well tolerated in girls aged 9 to 10 years, according to a study presented here at the 25th International Papillomavirus (IPV) Conference. "Both vaccines were well tolerated, and no significant adverse events were reported," said Vladimir Gilca, MD, Institut National de Santé Publique and Laval University, Sainte-Foy, Quebec, Canada, on May 11. "Most systemic and injection-site events were mild and resolved spontaneously within 4 days." The researchers aimed to assess the immunological response to the HPV vaccine plus HepA/HepB vaccine when coadministered and when administered 1 month apart, as well as to compare the safety profiles of both vaccines. The open-label, randomised study included 415 girls aged 9 to 10 years from Quebec City who were eligible for the HPV and HepA/HepB vaccination. The girls were randomised to receive both vaccinations either concomitantly or 1 month apart. The subanalysis presented included safety data after the first dose of vaccines was coadministered. Researchers assessed for vaccine immunogenicity and tolerability after the first dose, before and after the second dose given 6 months later, and before and after the third dose given at age 14 to 15 years. After the first vaccine coadministration, the investigators found that 46% of the patients reported at least 1 general adverse event (AE), and 75% had at least 1 local AE. Fatigue was the most common AE (27%), along with headache (23%), gastrointestinal symptoms (14%), muscle aches (9%), joint pain (4%), fever (3%), rash (3%), and hives (1%). The researchers noted that 91% of general AEs were mild, and all resolved within 4 days after the first vaccine coadministration. Injection-site reactions included pain (reported by 74% of the girls), redness (13%), and swelling (9%). Of these injection-site reactions, 96% resolved within 4 days, and all resolved within 7 days after covaccination. No statistically significant differences were found for injection-site reactions between the vaccines. One girl went to a local clinic about muscle aches 9 days after covaccination, and the family physician determined the symptom to be unrelated to the vaccines. [Presentation title: Gardasil and Twinrix Co-Administration: Preliminary Safety Data. Poster Presentation P-01.12]
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