Phase 3
N=344
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
Meningococcal Disease · Meningococcal Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT01423084 ↗Enrolled (actual)
344
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. — 111; 111; 9.27; 11 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Serogroup B meningococcal vaccine (Biological)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains. |
111; 111; 9.27; 11; 183; 199 | — |
| PRIMARY ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953 |
2729; 3291 | — |
| SECONDARY Percentage of Subjects in Each Lot With hSBA ≥ 1:5 |
99; 99; 70; 79; 100; 100 | — |
| SECONDARY Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains. |
104; 107; 8.63; 11; 156; 167 | — |
| SECONDARY Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953 |
122; 153 | — |
| SECONDARY hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. |
187; 171; 14; 20; 254; 339 | — |
| SECONDARY GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45. |
174; 157; 13; 20; 214; 243 | — |
| SECONDARY Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45. |
100; 100; 84; 96; 100; 100 | — |
| SECONDARY ELISA GMCs Against Vaccine Antigen 287-953 at Day 45. |
3742; 4798 | — |
| SECONDARY GMR of ELISA GMCs Against Antigen 287-953 at Day 45. |
166; 217 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) |
163; 170; 65; 75; 162; 170 | — |
| SECONDARY Number of Subjects Reporting Unsolicited AEs |
56; 55 | — |
| SECONDARY Number of Subjects Reporting SAEs and AE Leading to Withdrawal |
0; 0; 0; 1 | — |
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 (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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01423084). 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.