Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01423084
First received: August 23, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: Serogroup B meningococcal vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Consistency of two lots of rMenB+OMV NZ [ Time Frame: one month after the second vaccination ] [ Designated as safety issue: No ]
    Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of ELISA GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).


Secondary Outcome Measures:
  • Percentage of subjects in each lot with hSBA ≥ 5 [ Time Frame: one month after the second vaccination ] [ Designated as safety issue: No ]
    The percentage of subjects in each lot with hSBA ≥ 5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group

  • Geometric mean titer (GMT) of human Serum Bactericidal Assay (hSBA) and geometric mean ratio (GMR) [ Time Frame: at 1 month and 2 weeks after the second vaccination ] [ Designated as safety issue: No ]
    The hSBA GMT increase (post-vaccination to pre-vaccination geometric mean ratio [GMR]) and associated two-sided 95% CI at each time point for each of the three N. meningitidis serogroup B reference strains and for each vaccine group.

  • ELISA Geometric Mean concentration (GMC) [ Time Frame: at 1 month and 2 weeks after the second vaccination ] [ Designated as safety issue: No ]
    The ELISA GMC increase (post-vaccination to pre-vaccination GMR) and associated two-sided 95% CI at each time point for vaccine antigen 287-953 and for each vaccine group

  • Percentage of subjects with hSBA GMT in a subset for B strains [ Time Frame: at two weeks after second vaccination ] [ Designated as safety issue: No ]
    The hSBA GMT and associated two-sided 95% CI at two weeks after the second vaccination in a subset of approximately 160 subjects (approximately 80 per lot) for each of three N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and for each vaccine group.

  • ELISA GMC in a subset against antigen 287-953 [ Time Frame: at two weeks after the second vaccination ] [ Designated as safety issue: No ]
    The ELISA GMC and associated two-sided 95% CI at two weeks after the second vaccination in a subset of approximately 160 subjects (approximately 80 per lot) for vaccine antigen 287-953 for each vaccine group.

  • Percentage of subjects with hSBA ≥ 5 in a subset against B strain [ Time Frame: at 2 weeks after the second vaccination ] [ Designated as safety issue: No ]
    The percentage of subjects with hSBA ≥ 5 at 2 weeks after the second vaccination in a subset of approximately 160 subjects (80 per lot) for each N. meningitidis serogroup B reference strain and vaccine group.

  • Number of subjects with solicited local and systemic reactions [ Time Frame: 7 days post vaccination ] [ Designated as safety issue: Yes ]
    Local (i.e., injection site pain, erythema, swelling, induration) and systemic (i.e., fever [axillary temperature ≥ 38.0 °C], nausea, fatigue, myalgia, arthralgia, headache) reactions will be assessed for 7 days (including the day of vaccination) post each vaccination. SAEs, medically attended AEs and AEs that result in a subject's withdrawal from the study will be collected throughout the study period.


Enrollment: 344
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenB Lot 1
MenB vaccine Lot 1: 2 doses administered 1 month apart
Biological: Serogroup B meningococcal vaccine

All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or 2 doses of rMenB+OMV NZ Lot 2.

A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination

Active Comparator: MenB Lot 2
MenB vaccine Lot 2: 2 doses administered 1 month apart
Biological: Serogroup B meningococcal vaccine

All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or 2 doses of rMenB+OMV NZ Lot 2.

A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination


Detailed Description:

Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment
  • who are 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.

Exclusion Criteria:

  • History of any serogroup B meningococcal vaccination
  • Current or previous, confirmed or suspected disease caused by N. meningitidis
  • Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment
  • Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day
  • Antibiotic use within 3 days (72 hours) prior to enrollment
  • Pregnancy or nursing (breastfeeding) mothers
  • Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry
  • Any serious chronic or progressive disease, Known or suspected impairment/alteration of the immune system
  • 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
  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: NCT01423084

Locations
Australia, Queensland
Royal Children's Hospital
Herston, Queensland, Australia, 4029
AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre
Kippa-Ring, Queensland, Australia, 4021
AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street
Sherwood, Queensland, Australia, 4075
Australia, South Australia
Women's and Children's Hospital, 72 King William Road
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne
Melbourne, Victoria, Australia, 3010
Australia, Western Australia
Telethon Institute for Child Heath Research-cnr
Hamilton Street and Roberts Road-Subiaco, Western Australia, Australia, 6008
Canada, British Columbia
TASC Research Services, 1-15243 91st Avenue
Surrey, British Columbia, Canada, V3R 8P8
Canada, Nova Scotia
Colchester Regional Hospital Colchester Research Group, 68 Robie Street
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
Albion Finch Medical Centre, 1620 Albion Road, Suite 106
Etobicoke, Ontario, Canada, M9V 4B4
Medicor Research Inc, 359 Riverside, Suite 200
Sudbury, Ontario, Canada, P3E 1H5
Dr. Hartley Garfield Medicine Professional Corporation, 790 Bay Street, Suite 540
Toronto, Ontario, Canada, M5G 1N8
SKDS Research Inc, 221-679 Davis Dr.Newmarket
Toronto, Ontario, Canada, L3Y 5G8
Devonshire Clinical Research INC, 423 Devonshire Ave., Suite 301
Woodstock, Ontario, Canada, N4S 5P5
Sponsors and Collaborators
Novartis
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01423084     History of Changes
Other Study ID Numbers: V72_41
Study First Received: August 23, 2011
Last Updated: July 22, 2014
Health Authority: Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Meningococcal Meningitis
prevention, vaccination
adolescents

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014