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

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

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.

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).