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Swine Influenza

Phase 1

Prophylaxis of A/H3N2v Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Feb 17, 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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment627
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01855945Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.PHASE1 COMPLETED 627May 1, 2013Sep 1, 2014Feb 17, 201611 United States
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Study Endpoints
Primary Endpoints
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.
Day 1 through Day 7 after each vaccination

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to \<9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Day 1 through Day 7 after each vaccination

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to \<18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Day 1 through Day 7 after each vaccination

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to \< 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Day 1 through Day 7 after each vaccination

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Day 1 through Day 366

The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.

Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
Day 22, Day 43 post vaccination

The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.

Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
Day 1, Day 22, Day 43 post vaccination

The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.

Secondary Endpoints
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).
Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
Day 183 and Day 366 post vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL3.75 µg H3N2c HA + 0.125 mL MF59
Group BEXPERIMENTAL7.5 µg H3N2c HÁ + 0.250 mL MF59
Group CEXPERIMENTAL15 µg H3N2c unadjuvanted
Interventions
NameTypeDescription
Swine InfluenzaBIOLOGICALComparison of different dosages of vaccines
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Eligibility Criteria
Age Range3 Years — 92 Years
SexALL
Healthy VolunteersYes
Study Sites11

Inclusion Criteria: 1. Males and females 3 years of age and older 2. Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on...

Countries:United States
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