Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Condition: Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Control; Meningococcal B vaccine with antipyretic
Intervention description: Vaccine candidate formulation I; Vaccine candidate formulation II; Vaccine candidate formulation III; Vaccine candidate formulation IV; Vaccine candidate formulation V; Vaccine candidate formulation VI; Control; Vaccine candidate formulation I with antipyretic
Intervention MeSH terms: Antipyretics; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1507.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Meningitis; Antibody; Infants

Summary:

      This study is aimed at assessing the safety and immunogenicity of different doses and
      formulations of a new Novartis Meningococcal B Recombinant Vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy,
             gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg

          -  Available for all the visits scheduled in the study and for whom a parent/legal
             guardian is willing/able to comply with all protocol requirements

        Exclusion Criteria:

          -  Any meningococcal B or C vaccine administration

          -  Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell),
             Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and
             Pneumococcal antigens;

          -  Any ascertained or suspected disease caused by N. meningitidis

          -  Household contact with and/or intimate exposure to an individual with laboratory
             confirmed N. meningitidis

          -  History of severe allergic reaction after previous vaccinations

          -  Recent significant acute or chronic infection

          -  Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood
             draw;

          -  Any serious chronic or progressive disease according to the judgment of the
             investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic
             disease, progressive neurological disease or seizure, either associated with fever or
             as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV
             infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure
             or severe malnutrition)

          -  Any impairment/alteration of the immune system resulting from (for example):

               -  Receipt of any immunosuppressive therapy at any time since birth

               -  Receipt of immunostimulants at any time since birth

               -  Use of systemic corticosteroids or chronic use of inhaled high-potency
                  corticosteroids at any time since birth

          -  Receipt of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation

          -  Participation in another clinical trial

          -  Family members and household members of research staff

          -  History of seizure

          -  Any contraindication to paracetamol