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Study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Biologicals combined hepatitis A / hepatitis B vaccine administered according to a 0, 6 month schedule versus Twin...

Update Il y a 5 ans
Reference: EUCTR2015-001515-12

Study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Biologicals combined hepatitis A / hepatitis B vaccine administered according to a 0, 6 month schedule versus Twinrix™ Junior administered according to a 0, 1, 6 month schedule in healthy children between 1 to 11 years old

Woman and Man

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Extract

For the primary study: To demonstrate that the combined hepatitis A / hepatitis B (720/20) vaccine is not more reactogenic than Twinrix™ Junior. For the long term follow up (LTFU): To evaluate anti-HAV and anti-HBs antibody persistence at Year 2, Year 3, Year 4 and Year 5 after the first vaccine dose of the primary vaccination course (a two-dose schedule of Twinrix Adult 720/20 vaccine or a three-dose schedule of Twinrix Junior 360/10 vaccine). To evaluate the immune memory in the subjects who became seronegative for anti-HAV antibodies (i.e. anti-HAV antibody concentrations < 15 mIU/ml) or had anti-HBs antibody concentrations < 10 mIU/ml at the long-term blood sampling time-point (i.e. Year 2, 3, 4 or 5) and who received the challenge dose (administered 6 to 12 months after the Year 5 time-point).

Inclusion criteria

  • Vaccination of healthy children from 1 to 11 years old against Hepatitis

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