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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01973218
First received: October 25, 2013
Last updated: October 5, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Meningococcal Disease
Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ
Biological: Placebo
Biological: Meningococcal ACWY-CRM conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: No ]
    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:
  • The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 61/ Day 1 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 61 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 61/Day 1 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 through day 7 after each vaccination ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 through Day 61 ] [ Designated as safety issue: No ]
    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.


Enrollment: 264
Study Start Date: November 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rMenB
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study.
Biological: Meningococcal B Recombinant vaccine rMenB+OMV NZ
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.
Active Comparator: Placebo/MenACWY
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study.
Biological: Placebo
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Biological: Meningococcal ACWY-CRM conjugate vaccine
Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
Other Name: Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973218

Locations
Korea, Republic of
06 Kosin University Gospel Hospital 34, amnam-dong
Seo-gu, Busan, Korea, Republic of, 602-702
05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu
Ansan-si, Gyeonggi-do, Korea, Republic of, 425-707
04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup
Yangsan-si, Gyeongnam, Korea, Republic of, 626-770
07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil
Bundang-gu, Seongnam, Korea, Republic of, 463-707
01 Seoul National University Hospital 101 Daehang-ro,
Jongno-gu, Seoul, Korea, Republic of, 110-744,
03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong
Yangcheon-gu, Seoul, Korea, Republic of, 158-710
02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu
Incheon, Korea, Republic of, 400-711
Sponsors and Collaborators
Novartis Vaccines
Novartis
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01973218     History of Changes
Other Study ID Numbers: V72_42  20130090378 
Study First Received: October 25, 2013
Results First Received: February 20, 2015
Last Updated: October 5, 2015
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Novartis:
Meningitis, adolescents, Meningococcal B

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016