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Meningococcal B vaccine

Phase 2

Meningococcal Meningitis | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 7, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,507
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00937521Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old InfantsPHASE2 COMPLETED 1,507 — — Jul 1, 2009Feb 1, 2012Apr 7, 201538 Argentina, Chile +3
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Study Endpoints
Primary Endpoints
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
At baseline (pre-vaccination) and 30 days after the third vaccination.

To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.

Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
Day 1 to day 3 after first vaccination.

To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever \>=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.

Secondary Endpoints
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
After the third and the booster vaccination.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1OTHERVaccine candidate formulation I
2OTHERVaccine candidate formulation II
3OTHERVaccine candidate formulation III
4OTHERVaccine candidate formulation IV
5OTHERVaccine candidate formulation V
6OTHERVaccine candidate formulation VI
7OTHERControl
8OTHERVaccine candidate formulation I with antipyretic
Interventions
NameTypeDescription
Meningococcal B vaccineBIOLOGICALVaccine candidate formulation I
ControlBIOLOGICALControl
Meningococcal B vaccine with antipyreticBIOLOGICALVaccine candidate formulation I with antipyretic
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Eligibility Criteria
Age Range55 Days — 89 Days
SexALL
Healthy VolunteersYes
Study Sites38

Inclusion Criteria: * Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg * Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol re...

Countries:ArgentinaChileCzechiaHungaryItaly
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