A Phase 3, Open label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3600

Inclusion Criteria

Informed consent must be obtained for all the subjects before enrollment into the study
after the nature of the study has been explained.
Subjects eligible to be enrolled in the study should comply with the following criteria:
1. healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13;
2. for whom a parent/legal guardian has given written informed consent after the nature
of the study has been explained;
3. available for all the visits scheduled in the study;
4. in good health as determined by medical history, physical examination and clinical
judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous ascertained or suspected disease caused by N. meningitidis;
2. Household contact with and/or intimate exposure to an individual with laboratory
confirmed N. meningitidis;
3. History of severe allergic reaction after previous vaccinations or hypersensitivity to
any vaccine component;

4. Significant acute or chronic infection within the previous 7 days or axillary
temperature ≥ 38C within the previous day;
5. Antibiotics within 6 days prior to enrollment;
6. 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);
7. Known or suspected impairment/alteration of the immune system,
immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled
high-potency corticosteroids since birth;
8. Receipt of blood, blood products and/or plasma derivatives or any parenteral
immunoglobulin preparation;
9. Receipt of, or intent to immunize with another vaccine, within 30 days prior to
enrollment.10. Participation in a clinical trial other than Study V72P13 since birth or planned for
during this extension study;
11. Family members and household members of research staff;
12. Any condition which, in the opinion of the investigator, might interfere with the
evaluation of the study objectives.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method