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Haemophilus influenzae type b vaccine

Phase 3

Haemophilus Influenzae Type b (Hib) Infection | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 30, 2011

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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment1,330
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01226953Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy InfantsPHASE3 COMPLETED 660Oct 1, 2010Mar 1, 2011Dec 30, 20111 China
NCT01044316Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in ChinaPHASE3 COMPLETED 670Apr 1, 2010Dec 1, 2010Dec 30, 20111 China
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Study Endpoints
Primary Endpoints
Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination
30 days after last vaccination
Anti-PRP antibody levels at day 31 post last vaccination
30 days after last vaccination
Secondary Endpoints
Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)
30 days post last vaccination
Solicited local and systemic reactions, AEs, and SAEs
30 days post last vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Haemophilus influenzae type b (Hib) vaccineBIOLOGICALComparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines
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Eligibility Criteria
Age Range365 Days — 569 Days
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Infants 365-569 days of age. Exclusion Criteria: * Subjects who already received a booster dose of Hib vaccine. * History of serious reaction(s) following vaccination. * Any vaccination within 7 days of study vaccination. * Known or suspected immune impairment.

Countries:China
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