Status:
COMPLETED
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Meningococcal Disease
Meningococcal Meningitis
Eligibility:
All Genders
11-17 years
Phase:
PHASE3
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 (hS...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT01423084
Start Date
August 1 2011
End Date
December 1 2011
Last Update
February 20 2015
Active Locations (13)
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1
Royal Children's Hospital
Herston, Queensland, Australia, 4029
2
AusTrials Pty Ltd-Suites 6, 10 & 11, Peninsula Specialist Centre
Kippa-Ring, Queensland, Australia, 4021
3
AusTrials Pty Ltd-Suite 5, Level 1, 14 Primrose Street
Sherwood, Queensland, Australia, 4075
4
Women's and Children's Hospital, 72 King William Road
North Adelaide, South Australia, Australia, 5006