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A Phase 2 Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a new Novartis Meningococcal B Recombinant Vaccine evaluating the immunogenicity, tolerability ...

Update Il y a 5 ans
Reference: EUCTR2009-010106-11

A Phase 2 Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a new Novartis Meningococcal B Recombinant Vaccine evaluating the immunogenicity, tolerability and safety when given concomitantly with routine vaccines in 2-month-old infants

Woman and Man

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Extract

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.

Inclusion criteria

  • 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

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