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Cell-Derived Trivalent Subunit Influenza Vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Abbott Laboratories|Last Updated: Oct 25, 2013

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00889889Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus RevaccinationPHASE2 COMPLETED 1,270May 1, 2009Jan 1, 2011Oct 25, 201315 United States
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Study Endpoints
Primary Endpoints
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
6 months
Secondary Endpoints
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Cell-Derived Trivalent Subunit Influenza VaccineBIOLOGICALsurface antigen, inactivated, prepared in cell cultures
PlaceboBIOLOGICALPlacebo
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites15

Inclusion Criteria 1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged \>= 18 and \<= 64 years. 3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator. Exclusi...

Countries:United States
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