Long-Term Antibody Persistence at 1, 3 and 5 Years After a fourth dose of GSK Biologicals' Hib-MenCY-TT Vaccine compared to Ac-tHIB

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-004060-22

Femme et Homme

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Extrait

•To evaluate the long-term antibody persistence induced by 4 doses of Hib-MenCY-TT as compared to 4 doses of ActHIB given at 2, 4, 6, and 12 to 15 months of age in terms of the percentage of subjects with antibody to anti-PRP >= 0.15 µg/mL. •To evaluate the long-term antibody persistence induced by 4 doses of Hib-MenCY-TT given at 2, 4, 6, and 12 to 15 months of age in terms of percentage of subjects with hSBA-MenC and hSBA-MenY titers >= 1:8. •To evaluate the long-term antibody persistence induced by 3 doses of ActHIB given at 2, 4, 6 months of age, and a single dose of Hib-MenCY-TT at 12 to 15 months of age in terms of the percentage of subjects with anti-PRP concen-trations 0.15 µg/mL, hSBA-MenC and hSBA-MenY titers >= 1:8. Note: The hSBA-MenC and hSBA-MenY endpoint of titers >= 1:8 reflect the primary endpoint for the analysis of persistence years 3 and 5.


Critère d'inclusion

  • Invasive disease caused by Haemophilus type b and Neisseria meningitidis serogroups C and Y

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