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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01973218
First received: October 25, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

Assess the immunogenicity and safety of two doses of Novartis Meningococcal B recombinant vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11-17 years.


Condition Intervention Phase
Meningococcal Disease
Biological: Meningoccal B recombinat vaccine
Biological: Meningococcal ACWY-CRM conjugate vaccine and placebo
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 Meningococcal B Recombinant 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:
  • Immunogenicity: assess percentage of subjects with SBA titer higher than or equal to 1:4 [ Time Frame: 1 month after last vaccination (Day 61) ] [ Designated as safety issue: No ]
    Assess the Safety and Immunogenicity of two doses of Novartis Meningococcal B recombinant vaccine in adolescents aged between 11-17 years

  • Safety: assess percentage and numbers of subjects with local and systemic adverse events [ Time Frame: Until Day 7 post-each vaccination ] [ Designated as safety issue: Yes ]
  • Safety: SAEs, medically attended AEs and AEs leading to study withdrawal [ Time Frame: Until study end (Day 61) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity: SBA GMTs, GMRs and fourfold-rise [ Time Frame: Baseline (Day 1) and 1 month after last vaccination (Day 61) ] [ Designated as safety issue: No ]
    Immunogenicity of two doses of Novartis Meningococcal B recombinant vaccine in adolescents aged between 11-17 years

  • Immunogenicity: ELISA GMCs and GMRs [ Time Frame: Baseline (Day 1) and 1 month after last vaccination (Day 61) ] [ Designated as safety issue: No ]

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: Arm 1
MenB+OMV NZ
Biological: Meningoccal B recombinat vaccine
Intramuscular vaccination of 2 doses of 0.5 ml in the non-dominant arm
Active Comparator: Arm 2
MenACWY-CRM and placebo
Biological: Meningococcal ACWY-CRM conjugate vaccine and placebo
Intramuscular vaccination of 2 doses of 0.5 ml in the non-dominant arm

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
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
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01973218     History of Changes
Other Study ID Numbers: V72_42, 20130090378
Study First Received: October 25, 2013
Last Updated: April 8, 2014
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

ClinicalTrials.gov processed this record on July 22, 2014