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

Phase 1

• Conditions: An open-label extension study in subjects who previously participated and completed Study V72P13. Subjects will be assigned to receive either a fourth dose of rMenB+OMV NZ, or one or two-dose catch-up regimens of rMenB+OMV NZ according to whether they received three doses of rMenB+OMV NZ with routine vaccinations or routine vaccinations only as infants in V72P13. Subjects will be recruited from the same sites as in V72P13 in Europe.

• Registration Number: EUCTR2008-006301-17-CZ
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-23
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.healthy 12-month-old toddlers (0/ +59 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

1.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 > =38 centigrade 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