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BEGRIVAC

Phase 3

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Jan 5, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

Clinical trial landscape

BEGRIVAC · 1 trial · 1 indication

Phase 3 1
NCT01147081Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011Seasonal Influenza
COMPLETED142 Analytics
PHASE3COMPLETED
Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011
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 1 and on Day 22, and evaluation of safety of Begrivac
22 days (-1/+5)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
BEGRIVACBIOLOGICAL126 healthy subjects enrolled to receive, in open-label manner, one dose of Begrivax (influenza vaccine)
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Eligibility Criteria

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

Inclusion Criteria: 1. Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry; 2. Individuals able to comply with all the study requirements; 3. Individuals in good health as determined by medical history, ...

Countries:Germany
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Frequently asked questions about BEGRIVAC

What is BEGRIVAC used for?

BEGRIVAC is a seasonal influenza vaccine used for the prevention of seasonal influenza. It is a monovalent or multivalent inactivated split influenza vaccine designed to provide immunity against circulating influenza strains. The vaccine is intended for use in adults aged 18 years and older.

Who makes BEGRIVAC?

BEGRIVAC is developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The vaccine is part of Novartis's infectious disease portfolio, focusing on seasonal influenza prevention.

What phase is BEGRIVAC in?

BEGRIVAC is in Phase 3 clinical development. It has completed one Phase 3 trial, which evaluated its safety and immunogenicity. The vaccine is investigational and not yet approved for widespread use, as it remains under clinical evaluation.

What clinical trials is BEGRIVAC in?

BEGRIVAC has been studied in one completed Phase 3 clinical trial with the identifier NCT01147081. This trial assessed the safety and immunogenicity of the inactivated split influenza vaccine using the 2010/2011 strain composition. The study enrolled 142 healthy adult volunteers in Germany.

How does BEGRIVAC work?

BEGRIVAC works by stimulating the immune system to produce antibodies against influenza viruses. As an inactivated split vaccine, it contains disrupted viral particles that cannot cause disease but are recognized by the body, triggering a protective immune response against seasonal influenza strains.