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A phase IV, single-blinded, randomized, single centre study to demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, Engerix-B in multidose presentation t...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-005262-20

A phase IV, single-blinded, randomized, single centre study to demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, Engerix-B in multidose presentation to that elicited by Engerix-B in monodose presentation when administered according to 0, 1, 6 months schedule in healthy adults aged equal to or above 18 years

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Extrait

To demonstrate non-inferiority of multidose Engerix™-B to monodose Engerix™-B in terms of anti-HBs seroprotection rate elicited one month after complete vaccination course (i.e. at Month 7).

Critère d'inclusion

  • Vaccination against hepatitis B virus in healthy adults aged equal to or greater than 18 years at the time of first vaccination

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