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Adjuvanted influenza vaccine

Phase 3

Influenza Disease | 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

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment413

FDA Designations

No designations recorded

Clinical trial landscape

Adjuvanted influenza vaccine · 3 trials · 2 indications

Phase 3 1Phase 2 1Phase 1 1
NCT00519064Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic DiseasesInfluenza Disease
COMPLETED361 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases
Influenza Disease
NCT00519064361
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Study Endpoints

Primary Endpoints

Compare immunogenicity of a single IM inj. of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to A/H3N2 antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22
Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
36 Days

Secondary Endpoints

Compare immunogenicity of an IM injection of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to B antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22
Evaluate immunog. of a single IM inj. of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to A/H1N1 antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22
To evaluate the safety of a single IM injection of the two influenza vaccines, when administered to adult subjects with underlying chronic disease(s).
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2ACTIVE_COMPARATOR -
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Adjuvanted influenza vaccineBIOLOGICAL -
Influenza VaccineBIOLOGICAL1 dose of Influenza Vaccine
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 to 60 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases:moderate to severe hypertension, moderate to severe congestive heart failure, chronic obstr...

Countries:ItalySwitzerland
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Frequently asked questions about Adjuvanted influenza vaccine

What is Adjuvanted Influenza Vaccine used for?

Adjuvanted Influenza Vaccine is an investigational vaccine being developed for the prevention of influenza and influenza disease. It is designed to be administered to adults, including those affected by chronic diseases, to generate an immune response against seasonal influenza strains. The vaccine is currently in early clinical development.

Who makes Adjuvanted Influenza Vaccine?

Adjuvanted 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 company has conducted clinical trials evaluating the vaccine's safety and immunogenicity in adult populations.

What phase is Adjuvanted Influenza Vaccine in?

Adjuvanted Influenza Vaccine is currently in Phase 1 clinical development. While the overall program includes completed Phase 2 and Phase 3 trials, the most recent and ongoing development stage is Phase 1. The vaccine remains investigational and has not been approved by regulatory authorities.

What clinical trials is Adjuvanted Influenza Vaccine in?

Adjuvanted Influenza Vaccine has been evaluated in three completed clinical trials: NCT00519064, a Phase 3 study in adults with chronic diseases in Italy; NCT00522067, a Phase 2 study in adults aged 18-64 with chronic diseases; and NCT00735020, a Phase 1 study in healthy adults in Switzerland. All trials have been completed.

How does Adjuvanted Influenza Vaccine work?

Adjuvanted Influenza Vaccine is designed to stimulate the immune system to produce antibodies against influenza viruses. The vaccine contains inactivated influenza virus components combined with an adjuvant, which is intended to enhance the body's immune response to the vaccine antigens. This approach aims to provide protection against seasonal influenza infection.