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Monovalent inactivated influenza vaccine

Phase 3

Pre-pandemic 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

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

Monovalent inactivated influenza vaccine · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00848029Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects Using Four Different Vaccination SchedulesPre-pandemic Influenza Vaccine
COMPLETED240 Analytics
PHASE3COMPLETED
Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects Using Four Different Vaccination Schedules
Pre-pandemic Influenza VaccineUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of antibody response to a monovalent inactivated influenza vaccine adjuvanted with MF59 and uses a surface antigen from a potential pandemic homologous virus strain candidate (H5N1).
6 months
Evaluation of antibody response to a monovalent inactivated flu vaccine adjuvanted with MF59 and uses a surface antigen from a potential pandemic homologous virus strain candidate (H5N1), as measured by HI test,MN test,SRH test,on day 0,21,42 and 201
6 months
Evaluation of safety of the monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly Subjects.
6 months

Secondary Endpoints

Evaluation of safety of the monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult Subjects.
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
Monovalent inactivated influenza vaccineBIOLOGICALTwo doses of monovalent inactivated influenza adjuvanted vaccine
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects aged 18 to 60 years of age who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol; * In good health as determined by: * Medical history, * Physical examination, * Clinical judgm...

Countries:CzechiaHungary
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Frequently asked questions about Monovalent inactivated influenza vaccine

What is Monovalent inactivated influenza vaccine used for?

Monovalent inactivated influenza vaccine is used as a prepandemic and pre-pandemic influenza vaccine. It is designed to protect against potential pandemic influenza virus strains, specifically targeting the H5N1 strain in clinical trials.

Who makes Monovalent inactivated influenza vaccine?

Monovalent inactivated influenza vaccine is being developed by Novartis AG, which trades under the ticker NVS. The vaccine is currently in Phase 3 clinical development for prepandemic influenza indications.

What phase is Monovalent inactivated influenza vaccine in?

Monovalent inactivated influenza vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and immunogenicity.

What clinical trials is Monovalent inactivated influenza vaccine in?

Monovalent inactivated influenza vaccine has been studied in two completed clinical trials. NCT00841646 was a Phase 2 trial with 343 participants, and NCT00848029 was a Phase 3 trial with 240 participants. Both evaluated the vaccine's safety and immunogenicity in adult and elderly subjects.

How does Monovalent inactivated influenza vaccine work?

Monovalent inactivated influenza vaccine works by presenting a surface antigen from a potential pandemic virus strain candidate, H5N1, to the immune system. This antigen is adjuvanted with MF59C.1 (MF59) to enhance the immune response, helping the body develop immunity against the H5N1 strain.