Study to evaluate the immunogenicity, safety, and reactogenicity of TWINRIX ADULT containing 720 ELISA units of hepatitis A antigen and 20 μg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years

Woman and Man

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Extract

To evaluate anti-HAV and anti-HBs antibody persistence at Year 6 (i.e. Month 72), Year 7 (i.e. Month 84), Year 8 (i.e. Month 96), Year 9 (i.e. Month 108) and Year 10 (i.e. Month 120) after the first vaccine dose of two-dose pri-mary vaccination. To evaluate the immune memory (after a primary two-dose schedule of TWINRIX™ ADULT 720/20 vaccine) in subjects who became seronegative for anti-HAV antibod-ies (i.e. titres < 15 mIU/ml) or lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml) at Year 6, 7, 8, 9 or 10 and subjects who received an additional vaccine dose (administered between 6 to 12 months after the Year 10 time point).

Inclusion criteria

To protect healthy male and female children aged 1 to 11 years old included against hepatitis A and B

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Study to evaluate the immunogenicity, safety, and reactogenicity of TWINRIX ADULT containing 720 ELISA units of hepatitis A antigen and 20 μg of hepatitis B surface antigen, administered following a t...