Clinical trial NCT01973218: Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Official title: A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 Years in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Keywords: Meningitis, adolescents, Meningococcal B
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2013-10-31
Enrollment: 264
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.
timeFrame: Day 1 and Day 61
Secondary outcomes:
measure: The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.
timeFrame: Day 1 and Day 61
measure: The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
timeFrame: Day 61/ Day 1
measure: The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.
timeFrame: Day 61
measure: The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.
timeFrame: Day 1 and Day 61
measure: The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.
timeFrame: Day 61/Day 1
measure: The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.
timeFrame: Day 1 through day 7 after each vaccination
measure: The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.
timeFrame: Day 1 through Day 61
Other outcomes:
Locations:
city: Seo-gu
country: Korea, Republic of
facility: 06 Kosin University Gospel Hospital 34, amnam-dong
state: Busan
city: Ansan-si
country: Korea, Republic of
facility: 05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: 04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup
state: Gyeongnam
city: Bundang-gu
country: Korea, Republic of
facility: 07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil
state: Seongnam
city: Jongno-gu
country: Korea, Republic of
facility: 01 Seoul National University Hospital 101 Daehang-ro,
state: Seoul
city: Yangcheon-gu
country: Korea, Republic of
facility: 03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong
state: Seoul
city: Incheon
country: Korea, Republic of
facility: 02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Lee HJ, Choe YJ, Hong YJ, Kim KH, Park SE, Kim YK, Oh CE, Lee H, Song H, Bock H, Casula D, Bhusal C, Arora AK. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trial. Vaccine. 2016 Feb 24;34(9):1180-6. doi: 10.1016/j.vaccine.2016.01.033. Epub 2016 Jan 28.