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Pandemic influenza vaccine

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 24, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment4,400

FDA Designations

No designations recorded

Clinical trial landscape

Pandemic influenza vaccine · 1 trial · 1 indication

Phase 3 1
NCT00434733Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly SubjectsInfluenza
COMPLETED4,400 Analytics
PHASE3COMPLETED
Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse event rate

Secondary Endpoints

Seroconversion and seroprotection after two doses of H5N1 vaccine
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Pandemic influenza vaccineBIOLOGICAL -
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Eligibility Criteria

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

Inclusion Criteria: * Healthy Subjects 18 years of age who signed the informed consent Exclusion Criteria: * Receipt of another investigational agent within 4 weeks * Receipt of influenza vaccination for current season 2006/2007. * any acute disease or infection, history of neurological symptoms ...

Countries:Poland
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Frequently asked questions about Pandemic influenza vaccine

What is Pandemic influenza vaccine used for?

Pandemic influenza vaccine is used for influenza, specifically to provide immunity against pandemic influenza strains. It is an investigational vaccine being developed by Novartis AG for the prevention of influenza infection in adult and elderly populations.

Who makes Pandemic influenza vaccine?

Pandemic influenza vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The vaccine is currently in clinical development for the prevention of influenza.

What phase is Pandemic influenza vaccine in?

Pandemic influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, but the vaccine remains under investigation.

What clinical trials is Pandemic influenza vaccine in?

Pandemic influenza vaccine has one completed Phase 3 clinical trial, NCT00434733, which evaluated the immunogenicity, safety, and tolerability of two doses of FLUAD-H5N1 influenza vaccine in adult and elderly subjects. The trial enrolled 4,400 participants in Poland.

Is Pandemic influenza vaccine the same as FLUAD-H5N1?

Yes, Pandemic influenza vaccine is also known as FLUAD-H5N1. The Phase 3 clinical trial NCT00434733 specifically tested FLUAD-H5N1, which is the pandemic influenza vaccine formulation being developed by Novartis AG for influenza prevention.