Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Disease

Treatments: Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ; Biological: Placebo; Biological: Meningococcal ACWY-CRM conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01973218

20130090378 (Other Identifier)

V72_42

Details and patient eligibility

About

The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.

Enrollment: 264 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
2. Available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);
3. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
4. With a negative urine pregnancy test (for female subjects only).

Exclusion criteria

1. History of any meningococcal vaccine administration;
2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
4. Pregnancy or nursing (breastfeeding) mothers;
5. Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;
6. Any serious chronic or progressive disease;
7. Family members and household members of research staff;
8. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;
9. Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;
10. Antibiotics within 6 days prior to enrollment;
11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;
12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
13. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
14. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;
15. Participation in another clinical trial within the last 90 days or planned for during study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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264 participants in 2 patient groups

rMenB

Experimental group

Description:

Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.

Treatment:

Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ

Placebo/MenACWY

Active Comparator group

Description:

Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.

Treatment:

Biological: Meningococcal ACWY-CRM conjugate vaccine

Biological: Placebo