Femme et Homme
- | Pays : -
- | Organes : -
- | Spécialités : -
Extrait
Immunogenicity Objectives To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine induce sufficient immune response when given to healthy infants at 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:5, at 1 month after the third vaccination. Safety Objectives To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine will reduce the incidence of fever ≥ 38.5 °C (rectal) occurring within 3 days (day 1–3) following first vaccination as compared to rMenB+OMV NZ.
Critère d'inclusion
- The Novartis Meningococcal B Recombinant±OMV NZ vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B.
- This study is aimed at assessing the safety and immunogenicity of different doses and formulations (including decreasing OMV contents) of a Novartis Meningococcal B Recombinant Vaccine (rMenB + OMV NZ) in order to optimize its safety profile while maintaining sufficient immunogenicity