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inactivated split influenza vaccine

Phase 3

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 7, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment126

FDA Designations

No designations recorded

Clinical trial landscape

inactivated split influenza vaccine · 1 trial · 1 indication

Phase 3 1
NCT00945841Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010Seasonal Influenza
COMPLETED126 Analytics
PHASE3COMPLETED
Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010
Seasonal InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
21 days (-1/+7)
Evaluation of safety of inactivated split influenza vaccine
21 days (-1/+7)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1OTHER -

Interventions

NameTypeDescription
inactivated split influenza vaccineBIOLOGICAL1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: Subjects eligible for enrollment into this study are male and female adults who are 1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. Able to comply with all study requirements 3. In good health as determined by: * M...

Countries:Germany
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Frequently asked questions about inactivated split influenza vaccine

What is inactivated split influenza vaccine used for?

Inactivated split influenza vaccine is used for seasonal influenza. It is an investigational vaccine being studied for the prevention of seasonal flu. The vaccine is designed to elicit an immune response against the influenza strains included in the seasonal composition.

Who makes inactivated split influenza vaccine?

Inactivated split influenza vaccine is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for seasonal influenza.

What phase is inactivated split influenza vaccine in?

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

What clinical trials is inactivated split influenza vaccine in?

Inactivated split influenza vaccine has one completed Phase 3 trial, NCT00945841, titled 'Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010'. The trial enrolled 126 healthy volunteers aged 18 years and older in Germany.

Is inactivated split influenza vaccine a monoclonal antibody?

No, inactivated split influenza vaccine is not a monoclonal antibody. It is classified as a vaccine modality, specifically an inactivated split vaccine. The vaccine is designed to induce immunity against seasonal influenza, whereas monoclonal antibodies are laboratory-made proteins that target specific antigens.