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An Open-label, randomised, controlled, multi-centre study of the immunogenicity and safety of a booster dose of two different Hepatitis B vaccines to explore the anamnestic immune response in healthy ...

Update Il y a 4 ans
Reference: EUCTR2007-005168-29

An Open-label, randomised, controlled, multi-centre study of the immunogenicity and safety of a booster dose of two different Hepatitis B vaccines to explore the anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age with either HEXAVAC or INFANRIX-HEXA

Woman and Man

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Extract

Immunogenicity 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 (i.e. seroprotection rate) 1 month after a booster dose (4th dose of a Hepatitis B vaccine) of either HBVaxPRO 5 μg or ENGERIX-B 10 μg.

Inclusion criteria

  • anamnestic immune response in healthy 4 to 7 year-old children previously vaccinated at about 3, 5 and 11 to 13 months of age

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