Phase 3
N=264
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01973218 ↗Enrolled (actual)
264
Serious AEs
0.8%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. — 26; 24; 98; 27 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal B Recombinant vaccine rMenB+OMV NZ (Biological); Placebo (Biological); Meningococcal ACWY-CRM conjugate vaccine (Biological)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group. |
26; 24; 98; 27; 12; 10 | — |
| SECONDARY The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group. |
2.31; 2.18; 91; 2.56; 1.5; 1.37 | — |
| SECONDARY The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group. |
40; 1.18; 234; 1.34; 19; 1.11 | — |
| SECONDARY The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group. |
93; 8; 97; 6; 83; 6 | — |
| SECONDARY The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group. |
23; 26; 1208; 27 | — |
| SECONDARY The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups. |
52; 1.05 | — |
| SECONDARY The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group. |
160; 22; 158; 18; 62; 5 | — |
| SECONDARY The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group. |
45; 10; 30; 3; 2; 0 | — |
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.
Eligibility Criteria
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;
- Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;
- Antibiotics within 6 days prior to enrollment;
- Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;
- 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;
- Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;
- Participation in another clinical trial within the last 90 days or planned for during study.
Data sourced from ClinicalTrials.gov (NCT01973218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.