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H5N1 pandemic Influenza vaccine 3.75µg

Phase 2

Pandemic H5N1 Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Oct 12, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment722
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00914771Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two Monovalent H5N1 Influenza Vaccines Containing 2 Doses of H5N1 Influenza Antigen, in Non-elderly Adult and Elderly SubjectsPHASE2 COMPLETED 722 — — Sep 1, 2009Dec 1, 2009Oct 12, 201512 Poland, Turkey (Türkiye)
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Study Endpoints
Primary Endpoints
Day 43 post vaccination ratio of GMTs for the 2 different vaccine groups (3.75µ / 7.5µg) including two-sided 95% confidence intervals as measured by HI and SRH in the adult and elderly population combined.
43 days
Solicited local reactions: ecchymosis, erythema, induration, swelling and pain at injection site.
6 weeks
Solicited systemic reactions: headache, arthralgia, chills, fatigue, malaise, myalgia, nausea, sweating and fever as measured by axillary temperature for Day 1 through 7 and Day 22 to 28 of the study.
6 weeks
Secondary Endpoints
Geometric mean titers/area (GMTs/GMAs) on each blood sampling days as determined by HI and SRH, and the applicable geometric mean ratios.
6 weeks
Percentage of subjects achieving seroconversion or significant increase in antibody titer on each post-vaccination blood sampling days, as measured by HI and SRH.
6 weeks
Percentage of subjects achieving an HI titer ≥40/ SRH area ≥25mm² on each blood sampling days.
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposePREVENTION
Treatment Arms
ArmTypeDescription
H5N1 pandemic Influenza vaccine 3.75µgACTIVE_COMPARATOR -
H5N1 pandemic Influenza vaccine 7.5µgACTIVE_COMPARATOR -
Interventions
NameTypeDescription
H5N1 pandemic Influenza vaccine 3.75µgBIOLOGICAL2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 3.75µg H5N1 antigen
H5N1 pandemic Influenza vaccine 7.5µgBIOLOGICAL2 doses of monovalent MF59-adjuvanted H5N1 pandemic vaccine containing 7.5µg H5N1 antigen
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: * Males and females 18 yrs of age and above on the day of enrollment. * Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator * Documented consent obtained after the nature of the study has been explained acco...

Countries:PolandTurkey (Türkiye)
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