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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01423084
• Date of registration: 23/08/2011
• Primary sponsor: Novartis
• Public title: Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
• Scientific 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
• Date of first enrolment: August 2011
• Target sample size: 344
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01423084
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Countries of recruitment

Australia, Canada

Key inclusion & exclusion 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



Age minimum: 11 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Meningococcal Disease

Meningococcal Meningitis

Intervention(s)

Biological: Serogroup B meningococcal vaccine

Primary Outcome(s)

Consistency of two lots of rMenB+OMV NZ [Time Frame: one month after the second vaccination]

Secondary Outcome(s)

ELISA Geometric Mean concentration (GMC) [Time Frame: at 1 month and 2 weeks after the second vaccination]

ELISA GMC in a subset against antigen 287-953 [Time Frame: at two weeks after the second vaccination]

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]

Number of subjects with solicited local and systemic reactions [Time Frame: 7 days post vaccination]

Percentage of subjects in each lot with hSBA = 5 [Time Frame: one month after the second vaccination]

Percentage of subjects with hSBA = 5 in a subset against B strain [Time Frame: at 2 weeks after the second vaccination]

Percentage of subjects with hSBA GMT in a subset for B strains [Time Frame: at two weeks after second vaccination]

Secondary ID(s)

V72_41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Vaccines