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Trivalent Influenza Vaccine

Phase 4

Influenza | Vaccine | Infectious Disease |Novartis AG|Trials Updated: May 9, 2016

Trivalent Influenza Vaccine development status

Highest phase Phase 4 run by MedImmune LLC (NCT02473510)
Phase scored for NVSPhase 1
Registered trials 6 across 4 sponsors since Oct 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment450

FDA Designations

No designations recorded

Trivalent Influenza Vaccine clinical trials

Trivalent Influenza Vaccine · 1 trial · 1 indication

Phase 1 1
NCT00848848Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and OlderInfluenza
COMPLETED450 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older
Influenza
NCT00848848450
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Study Endpoints

Primary Endpoints

Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
21 days

Secondary Endpoints

Strain-specific influenza antibody titers will be used to assess Immunogenicity
21 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -
4ACTIVE_COMPARATOR -
5ACTIVE_COMPARATOR -
6ACTIVE_COMPARATOR -
7ACTIVE_COMPARATOR -
8ACTIVE_COMPARATOR -
9ACTIVE_COMPARATOR -
10ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Trivalent Influenza VaccineBIOLOGICAL1 dose of Trivalent Influenza Vaccine
Trivalent Influenza Vaccine + high ABIOLOGICAL1 dose of Trivalent Influenza Vaccine with high A content
Trivalent Influenza Vaccine + ¼ dose adjuvantBIOLOGICAL1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant
Trivalent Influenza Vaccine + high A + ¼ dose adjuvantBIOLOGICAL1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant
Trivalent Influenza Vaccine + ½ dose adjuvantBIOLOGICAL1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant
Trivalent Influenza Vaccine + high A + ½ dose adjuvantBIOLOGICAL1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant
Trivalent Influenza Vaccine + adjuvantBIOLOGICAL1 dose of Trivalent Influenza Vaccine plus adjuvant
Trivalent Influenza Vaccine + high A + adjuvantBIOLOGICAL1 dose of Trivalent Influenza Vaccine with high A plus adjuvant
Trivalent Influenza Vaccine intradermal doseBIOLOGICAL1 dose of Trivalent Influenza Vaccine intradermal dose
Trivalent Influenza Vaccine + high A intradermal doseBIOLOGICAL1 intradermal dose of Trivalent Influenza Vaccine + high A
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator. Exclusion Criteria: * Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted va...

Countries:Belgium
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Competitive Landscape -Influenza 35 trials

Top 8 of 11 competitors

CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK3PHASE3mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine
Moderna, Inc.MRNA2PHASE3mRNA-1018-H5, mRNA-1010, Fluarix Trivalent
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
Sanofi SA Sponsored ADRSNY4PHASE1H5N8 pandemic influenza vaccine (adjuvanted)
Hoffmann-La RocheRHHBY2PHASE3Baloxavir Marboxil
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sinovac Biotech Ltd.SVA1PHASE1Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine
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