Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Intervention: rMenB+OMV NZ; combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine; Pneumococcal vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1885.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease,; Neisseria meningitidis serogroup B,; Prevention,; Vaccination,; Infants

Summary:

      Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given
      concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 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 Secondary :To demonstrate that
      immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to
      healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant
      vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV
      NZ when given concomitantly with routine infant vaccines was non-inferior to that of
      rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess
      prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at
      baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine
      without rMenB+OMV NZ.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month old infants (55-89 days, inclusive), who were born after full term
             pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;

          -  For whom a parent/legal guardian has given written informed consent after the nature
             of the study has been explained.

        Exclusion Criteria:

          -  History of any meningococcal B or C vaccine administration;

          -  prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio,
             Haemophilus influenzae type b (Hib), and Pneumococcal antigens);

          -  Previous ascertained or suspected disease caused by N. meningitidis;

          -  History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component;

          -  Significant acute or chronic infection within the previous 7 days or axillary
             temperature major or equal to38 degrees within the previous day;

          -  Antibiotics within 6 days prior to enrollment;

          -  Any serious chronic or progressive disease;

          -  Known or suspected impairment or alteration of the immune system;

          -  Receipt of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation.