CompletedPhase 3

Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

South Korea264 participantsStarted 2013-11

Plain-language summary

The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged between 11 to 17 years.

Who can participate

Age range11 Years – 17 Years

SexALL

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Inclusion criteria

✓. Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
✓. 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;
✓. With a negative urine pregnancy test (for female subjects only).

Exclusion criteria

✕. History of any meningococcal vaccine administration;
✕. Current or previous, confirmed or suspected disease caused by N. meningitidis;
✕. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
✕. Pregnancy or nursing (breastfeeding) mothers;
✕. Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;
✕. Any serious chronic or progressive disease;
✕. Family members and household members of research staff;
✕. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;

What they're measuring

Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.

Timeframe: Day 1 and Day 61

Trial details

NCT IDNCT01973218

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2015-02-20

View on ClinicalTrials.gov More Meningococcal Disease trials