A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

Summary

Primary objective: * To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg . Secondary objectives: * Additional immunogenicity assessments * Standard safety assessment.

Timeline

Start

2008-10

Primary completion

2009-12

Completion

2010-03

Publications

• Zanetti A, Parlato A, Romano L, Desole MG, Ferrera G, Giurdanella F, Zuliani M, Richard P, Thomas S, Fiquet A. Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: an open-label, randomised trial in Italy. Vaccine. 2012 Aug 24;30(39):5770-5. doi: 10.1016/j.vaccine.2012.06.078. Epub 2012 Jul 9.

Drugs

Indications