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Adjuvanted seasonal influenza vaccine

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 1, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment197

FDA Designations

No designations recorded

Clinical trial landscape

Adjuvanted seasonal influenza vaccine · 1 trial · 1 indication

Phase 3 1
NCT01210898Immunogenicity and Safety of V70P5 Revaccination SubjectsInfluenza
COMPLETED197 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of V70P5 Revaccination Subjects
Influenza
NCT01210898197
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Study Endpoints

Primary Endpoints

Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection
22 days post vaccination
Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion
22 days post vaccination
Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion
22 days post vaccination
Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received
22 days post vaccination

Secondary Endpoints

Primary immunogenicity outcomes as per CBER criteria
Day 22
Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains
Day 22
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2EXPERIMENTAL -
Group 3EXPERIMENTAL -
Group 4EXPERIMENTAL -
Group 5EXPERIMENTAL -
Group 6EXPERIMENTAL -
Group 7EXPERIMENTAL -
Group 8EXPERIMENTAL -
Group 9EXPERIMENTAL -
Group 10EXPERIMENTAL -
Group 11EXPERIMENTAL -
Group 12EXPERIMENTAL -
Group 13EXPERIMENTAL -

Interventions

NameTypeDescription
Adjuvanted seasonal influenza vaccineBIOLOGICALFull or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
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Eligibility Criteria

Age Range18 Months to 96 Months
SexALL
Healthy VolunteersYes
Study Sites16

Inclusion Criteria: * Healthy male or female children that have previously participated in the V70P5 study in Finland. Exclusion Criteria: * Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.

Countries:Finland
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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about Adjuvanted seasonal influenza vaccine

What is Adjuvanted seasonal influenza vaccine used for?

Adjuvanted seasonal influenza vaccine is used for influenza, a viral respiratory infection. It is an investigational vaccine being developed to generate an immune response against seasonal flu strains. The vaccine is designed for use in individuals as young as 18 months, based on the clinical trial population.

Who makes Adjuvanted seasonal influenza vaccine?

Adjuvanted seasonal influenza vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The company conducted a Phase 3 clinical trial of the vaccine in Finland.

What phase is Adjuvanted seasonal influenza vaccine in?

Adjuvanted seasonal influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine remains under clinical investigation.

What clinical trials is Adjuvanted seasonal influenza vaccine in?

Adjuvanted seasonal influenza vaccine has one completed Phase 3 trial, NCT01210898, titled 'Immunogenicity and Safety of V70P5 Revaccination Subjects.' The trial enrolled 197 participants in Finland, included healthy volunteers of all sexes aged 18 months and older, and was a randomized, controlled study.

Is Adjuvanted seasonal influenza vaccine a monoclonal antibody?

Adjuvanted seasonal influenza vaccine is classified as a monoclonal antibody modality in the development pipeline. However, as a vaccine, its intended function is to induce an immune response against influenza rather than to act as a therapeutic antibody.