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

Novartis

Status and phase

Completed

Phase 3

Conditions

Meningococcal Meningitis

Meningococcal Disease

Treatments

Biological: Serogroup B meningococcal vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01423084

V72_41

Details and patient eligibility

About

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.

Full 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).

Enrollment

344 patients

Sex

All

Ages

11 to 17 years old

Volunteers

Accepts Healthy Volunteers

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