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Hexavalent vaccine

Phase 3

Neisseria Meningitidis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 11, 2017

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment350
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01839175Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster VaccinationPHASE3 COMPLETED 350 — — Apr 1, 2013Feb 1, 2015Sep 11, 201711 Finland
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Study Endpoints
Primary Endpoints
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Secondary Endpoints
Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL
Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Hexavalent vaccineBIOLOGICAL0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
NeisVac-CBIOLOGICAL0.5 mL intramuscular injection at 2 and 4 months of age
Prevenar 13BIOLOGICAL0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
RotaTeqBIOLOGICAL2 mL oral administration at 2, 3 and 4 months
NimenrixBIOLOGICAL0.5 mL intramuscular injection at 12 months
M-M-RVAXPROBIOLOGICAL0.5 mL intramuscular or subcutaneous injection at 13 months of age
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Eligibility Criteria
Age Range46 Days — 76 Days
SexALL
Healthy VolunteersYes
Study Sites11

Inclusion Criteria: * Healthy infant 46 to 74 days of age (both inclusive) * Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg * Subject's parent(s) or legal representative able to comply with the study procedures Exclusion Criteria: * Participation in another clinical ...

Countries:Finland
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