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Trivalent influenza subunit vaccine Influvac

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Abbott Laboratories|Last Updated: Dec 22, 2016

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
UNCONTROLLED
Total Trials3
Total Enrollment361
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02381418Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 SeasonPHASE3 COMPLETED 120 — — Mar 1, 2015Mar 1, 2015Dec 22, 20161 Australia
NCT01146015Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 SeasonPHASE3 COMPLETED 121 — — Jun 1, 2010Jul 1, 2010Aug 26, 20112 Belgium, Germany
NCT00881842Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 09/10 SeasonPHASE3 COMPLETED 120 — — Jun 1, 2009Jul 1, 2009Aug 26, 20112 Belgium, Germany
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Study Endpoints
Primary Endpoints
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.
3 weeks post vaccination

Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.

HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
2 weeks
HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2010/2011 as defined by the CHMP guideline for influenza vaccines
3 weeks
HI titers and its derived parameters after 2 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.
2 weeks
HI titers and its derived parameters after 3 weeks (seroprotection, seroconversion and mean fold increase), reactogenicity and inconvenience of Influvac® 2008/2009 as defined by the CHMP guideline for influenza vaccines.
3 weeks
Secondary Endpoints
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
up to 3 weeks post vaccination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALTrivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
Interventions
NameTypeDescription
Trivalent influenza subunit vaccine InfluvacBIOLOGICAL"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Willing and able to give informed consent and able to adhere to all protocol required study procedures. * Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. * Being in good health as judged by medical history, physical examination (if ...

Countries:AustraliaBelgiumGermany
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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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