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Haemophilus influenzae type b

Phase 3

Haemophilus Influenzae Type b | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Feb 8, 2012

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment956
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00808392Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type bPHASE3 COMPLETED 916 — — Nov 1, 2008Feb 1, 2009Dec 29, 20112 China
NCT00734565Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type bPHASE1 COMPLETED 40 — — Jul 1, 2008Oct 1, 2008Feb 8, 20121 China
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Study Endpoints
Primary Endpoints
Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).
90 days
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.
30 days
Secondary Endpoints
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.
90 days
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after second vaccination dose will be evaluated.
90 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Haemophilus influenzae type b vaccineBIOLOGICAL3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
Commercial Haemophilus influenzae type b vaccineBIOLOGICAL3 doses one month apart of Haemophilus influenzae type b vaccine.
Haemophilus influenzae type bBIOLOGICAL1 dose monovalent conjugated vaccine against Haemophilus influenzae type b in children aged 16 - 20 months and infants aged 2 - 4 months
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Eligibility Criteria
Age Range2 Months — 4 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Infants of either sex, aged 2 - 4 months * In good health as determined by: * medical history * physical examination * clinical judgment of the investigator; * Available for all visits scheduled in the study and able to comply with all study regulations * For whom writt...

Countries:China
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