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Seasonal vaccine

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Jun 3, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment292

FDA Designations

No designations recorded

Clinical trial landscape

Seasonal vaccine · 1 trial · 1 indication

Phase 1 1
NCT00798343Heterosubtypic Immune Responses to Influenza in Older PeopleInfluenza
COMPLETED292 Analytics
PHASE1COMPLETED
Heterosubtypic Immune Responses to Influenza in Older People
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Neutralising antibody to influenza subtypes
18 months

Secondary Endpoints

Reactogenicity (local and systemic) to H5N1 vaccine
18 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Seasonal vaccineACTIVE_COMPARATORSeasonal influenza vaccination
Pandemic vaccineEXPERIMENTALMF59-adjuvanted H5N1 monovalent vaccine

Interventions

NameTypeDescription
Seasonal vaccineBIOLOGICALNon-adjuvanted seasonal influenza vaccine (total dose 45ug)
H5 vaccineBIOLOGICALMF59-adjuvanted A/Vietnam/1194 H5N1 vaccine 7.5ug dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects aged over 18 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol; 2. Subjects willing to be enrolled in the vaccine study if appropriate from prescreening blood test results 3. ...

Countries:United Kingdom
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Frequently asked questions about Seasonal vaccine

What is Seasonal vaccine used for in Influenza?

Seasonal vaccine is an investigational monoclonal antibody being developed for Influenza, an infectious disease. It is currently in Phase 1 clinical development. The vaccine is designed to address seasonal influenza, though specific efficacy data has not been disclosed.

Who makes Seasonal vaccine?

Seasonal vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity in healthy volunteers.

What phase is Seasonal vaccine in?

Seasonal vaccine is currently in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 1 trial has been completed, with results not yet publicly reported.

What clinical trials is Seasonal vaccine in?

Seasonal vaccine has one completed clinical trial, identified as NCT00798343, titled 'Heterosubtypic Immune Responses to Influenza in Older People.' This Phase 1 study enrolled 292 participants in the United Kingdom, including healthy volunteers aged 18 years and older.

Is Seasonal vaccine the same as a flu shot?

Seasonal vaccine is not a traditional flu shot. It is a monoclonal antibody, a laboratory-made protein that mimics the immune system's ability to fight off pathogens. It is being investigated for its potential to provide immunity against influenza, but it is not a conventional vaccine.