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Fluad H5N1 Pandemic Influenza Vaccine

Phase 2

Prophylaxis of Avian Influenza Vaccine | 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

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

Clinical trial landscape

Fluad H5N1 Pandemic Influenza Vaccine · 1 trial · 1 indication

Phase 2 1
NCT00478816Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza VaccinesProphylaxis of Avian Influenza Vaccine
COMPLETED58 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines
Prophylaxis of Avian Influenza VaccineUnlock trial analytics

Study Endpoints

Primary Endpoints

Cell-mediated immunity, magnitude, breath and kinetics of antibody response to 2 doses of MF59-adjuvanted H5N1 influenza vaccine, in subjects primed by previous vaccination with either MF59-adjuvanted or non-adjuvanted H5N3 influenza vaccine.
Days 1, 8, 15, 22, 43 and 202

Secondary Endpoints

Safety Objectives: safety and reactogenicity of the vaccine
Days 1, 8, 15, 22, 43 and 202
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1ACTIVE_COMPARATORPrimed subject with pandemic Vaccine
Group 2ACTIVE_COMPARATORNon Primed subject with pandemic Vaccine

Interventions

NameTypeDescription
Fluad H5N1 Pandemic Influenza VaccineBIOLOGICALTwo 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects aged 18 to 65 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol; 2. In good health as determined by: 1. medical history, 2. physical examination, 3. clinical judgmen...

Countries:United Kingdom
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Frequently asked questions about Fluad H5N1 Pandemic Influenza Vaccine

What is Fluad H5N1 Pandemic Influenza Vaccine used for?

Fluad H5N1 Pandemic Influenza Vaccine is used for the prophylaxis of avian influenza, also known as bird flu. It is an investigational vaccine being developed to prevent infection with the H5N1 influenza virus. The vaccine is intended for use in adults and is currently in clinical development.

Who makes Fluad H5N1 Pandemic Influenza Vaccine?

Fluad H5N1 Pandemic Influenza Vaccine is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and immunogenicity of this pandemic influenza vaccine.

What phase is Fluad H5N1 Pandemic Influenza Vaccine in?

Fluad H5N1 Pandemic Influenza Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The vaccine is being studied for its safety and ability to generate an immune response against the H5N1 avian influenza virus.

What clinical trials is Fluad H5N1 Pandemic Influenza Vaccine in?

Fluad H5N1 Pandemic Influenza Vaccine has been studied in one completed Phase 2 clinical trial with the identifier NCT00478816. This trial evaluated the safety and immunogenicity of two doses of the H5N1 influenza vaccine in adults who were either unprimed or primed with adjuvanted or non-adjuvanted influenza vaccines. The study enrolled 58 participants in the United Kingdom.

What does Fluad H5N1 Pandemic Influenza Vaccine target?

Fluad H5N1 Pandemic Influenza Vaccine targets the H5N1 strain of the influenza virus, which is a subtype of avian influenza. The vaccine is designed to stimulate the immune system to produce antibodies against this specific virus strain, providing protection against infection. It is being developed as a preventive measure for pandemic preparedness.

Is Fluad H5N1 Pandemic Influenza Vaccine the same as other influenza vaccines?

Fluad H5N1 Pandemic Influenza Vaccine is a specific vaccine developed for the H5N1 avian influenza virus, distinct from seasonal influenza vaccines. It is an investigational product and not the same as the standard Fluad vaccine used for seasonal flu. The vaccine is being evaluated for its potential use in a pandemic scenario.