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

Phase 3

Completed

• Conditions: Meningococcal Disease
• Interventions: Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ; Biological: Placebo; Biological: Meningococcal ACWY-CRM conjugate vaccine

• Registration Number: NCT01973218
• Lead Sponsor: Novartis Vaccines

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-10-31
• Study Start: 2013-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-02-20
• Results First Submitted QC: 2015-02-20
• Results First Posted: 2015-03-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rMenB	Meningococcal B Recombinant vaccine rMenB+OMV NZ	Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.
Placebo/MenACWY	Placebo	Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.
Placebo/MenACWY	Meningococcal ACWY-CRM conjugate vaccine	Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.	Day 1 and Day 61	Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.

Secondary Outcome Measures

Name	Time	Method
The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.	Day 1 and Day 61	The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.
The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.	Day 61/ Day 1	The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.
The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.	Day 61	Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.
The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.	Day 1 and Day 61	The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.
The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.	Day 61/Day 1	The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.
The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.	Day 1 through day 7 after each vaccination	The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.
The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.	Day 1 through Day 61	The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.

Trial Locations

Locations (7)

06 Kosin University Gospel Hospital 34, amnam-dong; 🇰🇷 Seo-gu, Busan, Korea, Republic of

04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup; 🇰🇷 Yangsan-si, Gyeongnam, Korea, Republic of

05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu; 🇰🇷 Ansan-si, Gyeonggi-do, Korea, Republic of

07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil; 🇰🇷 Bundang-gu, Seongnam, Korea, Republic of

01 Seoul National University Hospital 101 Daehang-ro,; 🇰🇷 Jongno-gu, Seoul, Korea, Republic of

03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong; 🇰🇷 Yangcheon-gu, Seoul, Korea, Republic of

02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu; 🇰🇷 Incheon, Korea, Republic of