The vaccine response and long-term antibody persistence of GSK Biologicals’ MenACWY-TT vaccine (GSK134612) administered as one dose at 6 years post-MenC primary vaccination in healthy subjects aged 12...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-002575-34

The vaccine response and long-term antibody persistence of GSK Biologicals’ MenACWY-TT vaccine (GSK134612) administered as one dose at 6 years post-MenC primary vaccination in healthy subjects aged 12-18 months at primary vaccination

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Extrait

•To evaluate the immunogenicity of MenACWY-TT conjugate vaccine in terms of the percentage of subjects with an rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*. *Vaccine response to meningococcal antigens (A, C, W-135 and Y) is defined as: - For initially seronegative subjects (pre-vaccination rSBA titer below 1:8): rSBA antibody titer ≥ 1:32 one month after vaccination, and - For initially seropositive subjects (pre-vaccination rSBA titer ≥ 1:8): at least four-fold increase in rSBA titers from pre-vaccination to one month after vaccination.


Critère d'inclusion

  • Active immunization against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y