Clinical trial NCT01423084: Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal Meningitis
prevention, vaccination
adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2011-08-25
Enrollment: 344
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.
timeFrame: One month after the second vaccination (day 61)
measure: ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953
timeFrame: One month after the second vaccination (day 61)
Secondary outcomes:
measure: Percentage of Subjects in Each Lot With hSBA ≥ 1:5
timeFrame: One month after the second vaccination (day 61)
measure: Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.
timeFrame: One month after the second vaccination (day 61)
measure: Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953
timeFrame: One month after the second vaccination (day 61)
measure: hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
timeFrame: Two weeks after the second vaccination (day 45)
measure: GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.
timeFrame: Two weeks after the second vaccination (day 45)
measure: Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.
timeFrame: Two weeks after the second vaccination (day 45)
measure: ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.
timeFrame: Two weeks after the second vaccination (day 45)
measure: GMR of ELISA GMCs Against Antigen 287-953 at Day 45.
timeFrame: Two weeks after the second vaccination (day 45)
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
timeFrame: From day 1 to day 7 after any vaccination
measure: Number of Subjects Reporting Unsolicited AEs
timeFrame: From day 1 to day 7 after any vaccination.
measure: Number of Subjects Reporting SAEs and AE Leading to Withdrawal
timeFrame: Throughout the study period.
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Royal Children's Hospital
state: Queensland
city: Kippa-Ring
country: Australia
facility: AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre
state: Queensland
city: Sherwood
country: Australia
facility: AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street
state: Queensland
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital, 72 King William Road
state: South Australia
city: Melbourne
country: Australia
facility: Murdoch Children's Research Institute-Level 5, 207 Bouverie St-University of Melbourne
state: Victoria
city: Hamilton Street and Roberts Road-Subiaco
country: Australia
facility: Telethon Institute for Child Heath Research-cnr
state: Western Australia
city: Surrey
country: Canada
facility: TASC Research Services, 1-15243 91st Avenue
state: British Columbia
city: Truro
country: Canada
facility: Colchester Regional Hospital Colchester Research Group, 68 Robie Street
state: Nova Scotia
city: Etobicoke
country: Canada
facility: Albion Finch Medical Centre, 1620 Albion Road, Suite 106
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc, 359 Riverside, Suite 200
state: Ontario
city: Toronto
country: Canada
facility: SKDS Research Inc, 221-679 Davis Dr.Newmarket
state: Ontario
city: Toronto
country: Canada
facility: Dr. Hartley Garfield Medicine Professional Corporation, 790 Bay Street, Suite 540
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research INC, 423 Devonshire Ave., Suite 301
state: Ontario
Study officials:
References:
citation: Perrett KP, McVernon J, Richmond PC, Marshall H, Nissen M, August A, Percell S, Toneatto D, Nolan T. Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents: a phase III, randomized, multicentre, lot-to-lot consistency study. Vaccine. 2015 Sep 22;33(39):5217-24. doi: 10.1016/j.vaccine.2015.06.103. Epub 2015 Jul 29.