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

NCT01973218 | Completed Phase 3 Results

• 2 other identifiers: V72_4220130090378
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 7

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.

Conditions

Meningococcal Disease

Keywords

Meningitis, adolescents, Meningococcal B

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.

  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.

  Day 1 and Day 61

Secondary Outcomes (7)

• The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.

  Day 1 and Day 61

• 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 Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.

  Day 61

• The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.

  Day 1 and Day 61

• The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.

  Day 61/Day 1

Study Arms (2)

rMenB

EXPERIMENTAL

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

Placebo/MenACWY

ACTIVE COMPARATOR

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

Biological: Placebo; Biological: Meningococcal ACWY-CRM conjugate vaccine

Interventions

Meningococcal B Recombinant vaccine rMenB+OMV NZ BIOLOGICAL

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.

rMenB

Placebo BIOLOGICAL

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.

Placebo/MenACWY

Meningococcal ACWY-CRM conjugate vaccine BIOLOGICAL

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.

Also known as: Meningococcal (groups A,C,W,and Y) oligosaccharide diphtheria CRM-197

Placebo/MenACWY

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• Available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);
• In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
• With a negative urine pregnancy test (for female subjects only).

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Vaccines: lead
• Novartis: collaborator

Study Sites (7)

06 Kosin University Gospel Hospital 34, amnam-dong

Seo-gu, Busan, 602-702, South Korea

Location

05 YuKorea University Ansan Hospital 23, Jeokgeum-ro, Danwon-gu

Ansan-si, Gyeonggi-do, 425-707, South Korea

Location

04 Pusan National University Yangsan Hospital 20 Geumo-ro, Mulgeum-eup

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

07 Seoul National University Bundang Hospital 82, Gumi-ro 173 Beon-gil

Bundang-gu, Seongnam, 463-707, South Korea

Location

01 Seoul National University Hospital 101 Daehang-ro,

Jongno-gu, Seoul, 110-744,, South Korea

Location

03 Ewha Womans University Mokdong Hospital, Department of Pediatrics, 911-1 Mokdong

Yangch’ŏn-gu, Seoul, 158-710, South Korea

Location

02 Inha University Hospital 7-206, 3rd street, Shinheung-dong, Jung-gu

Incheon, 400-711, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26826544 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 30, 2015
• Results First Posted: March 6, 2015

Record last verified: 2015-10

Locations

KR (7)