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Split, Inactivated, Trivalent Influenza Vaccine

Phase 2

Orthomyxoviridae Infection | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Apr 18, 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_CONTROLLEDDMC
Total Trials2
Total Enrollment1,337
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00391391Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and ChildrenPHASE2 COMPLETED 520 — — Oct 1, 2006Oct 1, 2007Dec 1, 201119 United States
NCT00388583Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly SubjectsPHASE2 COMPLETED 817 — — Sep 1, 2006Sep 1, 2008Apr 18, 201217 United States
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Study Endpoints
Primary Endpoints
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Day 0 and Day 28 post-vaccination

Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Pre-vaccination and Day 28 post-vaccination

The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.

Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Day 28 post-vaccination

Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40

Secondary Endpoints
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Day 28 post-vaccination
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Day 28 post-vaccination
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Day 28 post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSplit, Inactivated, Trivalent Influenza Vaccine
2EXPERIMENTALSplit, Inactivated, Trivalent Influenza Vaccine
3ACTIVE_COMPARATORSplit, Inactivated, Trivalent Influenza Vaccine
4ACTIVE_COMPARATORSplit, Inactivated, Trivalent Influenza Vaccine
Fluzone Intradermal (ID) Vaccine GroupEXPERIMENTALParticipants received a dose of Fluzone Intradermal (ID) Influenza Vaccine
Fluzone Intramuscular (IM) Vaccine GroupACTIVE_COMPARATORParticipants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine.
Interventions
NameTypeDescription
Split, Inactivated, Trivalent Influenza VaccineBIOLOGICALVaccine (infant dose)
Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)BIOLOGICALVaccine (infant dose)
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Eligibility Criteria
Age Range6 Months — 8 Years
SexALL
Healthy VolunteersYes
Study Sites19

Inclusion Criteria : * Aged 6 months to 8 years but not yet 9 years on the day of inclusion. * Subject is healthy, as determined by medical history. * Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved in...

Countries:United States
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