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Study to compare the immunogenicity of GlaxoSmithKline Biologicals' thiomersal-free 2-dose Engerix™-B and 3-dose preservative-free Engerix™-B vaccines administered according to a 0, 6 month and 0, 1, ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-001531-20

Study to compare the immunogenicity of GlaxoSmithKline Biologicals' thiomersal-free 2-dose Engerix™-B and 3-dose preservative-free Engerix™-B vaccines administered according to a 0, 6 month and 0, 1, 6 month schedule, respectively, and to evaluate safety and reactogenicity of each vaccine in healthy adolescent volunteers (11 to 15 years)

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Extrait

For the primary Epoch: To demonstrate non-inferiority of the immune response induced by (thiomersal-free) Engerix™-B (20 mcg HBsAg) administered as a 2-dose vaccination schedule compared to (preservative-free) Engerix™-B (10 mcg HBsAg) administered as a 3-dose vaccination schedule, one month after the full vaccination course (month 7). For the long term follow-up (LTFU): To evaluate anti-HBs antibody persistence at Months 30, 42, 54 and 66 after the first vaccine dose of primary vac-cination.

Critère d'inclusion

  • Hepatitis B vaccination of healthy adolescents

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