A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine; Meningococcal C oligosaccharide conjugated vaccine; Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.; rMenB + OMV NZ vaccine; rMenB + OMV NZ vaccine
Intervention description: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age); 2 doses (3.5, 5 months of age) plus booster (11 months of age); 2 doses (6, 8 months of age) plus booster (11 months of age); 2 doses 2 months apart; Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine; Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.; Schedule 3, 5, 12 rMenB + OMV vaccine; Schedule 13,15 rMenB + OMV vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1409.0
Sex: All
Minimum age: 71 Days
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; Vaccines; intercalated administration

Summary:

      The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when
      administered alone without routine infant vaccines to healthy infants in their first year of
      life according to different two and three dose immunization schedules, which are suitable to
      be adopted by various national programs. This study will also investigate antibody
      persistence post primary series and administration of a subsequent booster dose of rMenB+OMV
      NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of
      two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of
      age.

      This study will also evaluate the safety and immunogenicity of the concomitant administration
      of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and
      12-month schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy infants and children according to the following age groups:

               -  Healthy infants 2½ months of age (71 -79 days, inclusive), (only applicable to
                  group I)

               -  Healthy infants 3½ months of age (101 -109 days, inclusive), (only applicable to
                  group II)

               -  Healthy infants 6 months of age (only applicable to group III) (The age window is
                  defined as the first day the subject turns 6 months of age up to the day before
                  the subject turns 7 months of age).

               -  Healthy children 2 to 5 years of age (only applicable to group IVa) (The age
                  window is defined as the first day the subject turns 2 years of age up to the day
                  before the subject turns 6 years of age).

               -  Healthy children 6 to 10 years of age (only applicable to group IVb) (The age
                  window is defined as the first day the subject turns 6 years of age up to the day
                  before the subject turns 11 years of age).

               -  Healthy infants 3 months of age (83-104 days, inclusive), (only applicable to
                  Group V and VI).

          2. For whom parent(s)/legal guardian(s) have given written informed consent according to
             local regulations after the nature of the study has been explained;

          3. Available for all the visits scheduled in the study;

          4. Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

        Exclusion Criteria:

          1. Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written
             informed consent to participate in the study;

          2. Children's parents or legal guardian who are not able to comprehend and to follow all
             required study procedures for the whole period of the study.

          3. History of any meningococcal B vaccine administration;

          4. Previous ascertained or suspected disease caused by N. meningitidis;

          5. Household contact with and/or intimate exposure to an individual with laboratory
             confirmed N. meningitidis;

          6. History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component

          7. Significant acute or chronic infection within the previous 7 days or temperature 38° C
             within the previous day of receiving the study vaccine;

          8. Antibiotics treatment within 6 days prior to enrollment;

          9. Individuals with history of allergy to vaccine components.

         10. Any serious chronic or progressive disease according to the judgment of the
             investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic
             disease, 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);

         11. Known or suspected impairment/alteration of the immune system, immunosuppressive
             therapy, use of high dose systemic corticosteroids or chronic use of inhaled
             high-potency corticosteroids within 14 days prior to enrollment (use of low or
             moderate doses of inhaled steroids is not an exclusion);

         12. Receipt of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation within 90 days prior to enrollment.

         13. Receipt of, or intent to immunize with, any other vaccine(s) within 7 days prior to
             enrollment.

         14. Individuals participating in any clinical trial with another investigational product
             30 days prior to first study visit or intent to participate in another clinical study
             at any time during the conduct of this study.

         15. Family members and household members of research staff

         16. Individuals with history or any illness that, in the opinion of the investigator,
             might interfere with the results of the study or pose additional risk to the subjects
             due to participation in the study.

         17. History of any meningococcal C vaccine administration (Only applicable to group V and
             VI).

         18. History of any Pneumococcal vaccine administration (Only applicable to group V and
             VI).