Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
- Conditions
- Meningococcal DiseaseMeningococcal Meningitis
- Interventions
- Biological: Serogroup B meningococcal vaccine
- Registration Number
- NCT01423084
- Lead Sponsor
- Novartis
- Brief Summary
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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MenB Lot 1 Serogroup B meningococcal vaccine MenB vaccine Lot 1: 2 doses administered 1 month apart MenB Lot 2 Serogroup B meningococcal vaccine MenB vaccine Lot 2: 2 doses administered 1 month apart
- Primary Outcome Measures
Name Time Method Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. One month after the second vaccination (day 61) 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 Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).
ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953 One month after the second vaccination (day 61) The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects in Each Lot With hSBA ≥ 1:5 One month after the second vaccination (day 61) The percentage of subjects in each lot with hSBA ≥ 1:5 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 Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. One month after the second vaccination (day 61) The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).
Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953 One month after the second vaccination (day 61) The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).
hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. Two weeks after the second vaccination (day 45) The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.
GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. Two weeks after the second vaccination (day 45) The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N.
meningitidis serogroup B reference strains at two weeks after last vaccination.Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. Two weeks after the second vaccination (day 45) The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.
ELISA GMCs Against Vaccine Antigen 287-953 at Day 45. Two weeks after the second vaccination (day 45) The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
GMR of ELISA GMCs Against Antigen 287-953 at Day 45. Two weeks after the second vaccination (day 45) The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) From day 1 to day 7 after any vaccination Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.
Number of Subjects Reporting Unsolicited AEs From day 1 to day 7 after any vaccination. Number of subjects reporting any Unsolicited AEs after any vaccination.
Number of Subjects Reporting SAEs and AE Leading to Withdrawal Throughout the study period. Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.
Trial Locations
- Locations (13)
Telethon Institute for Child Heath Research-cnr
🇦🇺Hamilton Street and Roberts Road-Subiaco, Western Australia, Australia
AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre
🇦🇺Kippa-Ring, Queensland, Australia
SKDS Research Inc, 221-679 Davis Dr.Newmarket
🇨🇦Toronto, Ontario, Canada
Royal Children's Hospital
🇦🇺Herston, Queensland, Australia
Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne
🇦🇺Melbourne, Victoria, Australia
Albion Finch Medical Centre, 1620 Albion Road, Suite 106
🇨🇦Etobicoke, Ontario, Canada
Medicor Research Inc, 359 Riverside, Suite 200
🇨🇦Sudbury, Ontario, Canada
Colchester Regional Hospital Colchester Research Group, 68 Robie Street
🇨🇦Truro, Nova Scotia, Canada
AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street
🇦🇺Sherwood, Queensland, Australia
Women's and Children's Hospital, 72 King William Road
🇦🇺North Adelaide, South Australia, Australia
Devonshire Clinical Research INC, 423 Devonshire Ave., Suite 301
🇨🇦Woodstock, Ontario, Canada
Dr. Hartley Garfield Medicine Professional Corporation, 790 Bay Street, Suite 540
🇨🇦Toronto, Ontario, Canada
TASC Research Services, 1-15243 91st Avenue
🇨🇦Surrey, British Columbia, Canada