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influenza vaccine

Phase 3

Influenza | 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

RandomizedCONTROLLED
Total Trials3
Total Enrollment931

FDA Designations

No designations recorded

Clinical trial landscape

influenza vaccine · 5 trials · 2 indications

Phase 3 1Phase 2 4
NCT00310648Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)Influenza
COMPLETED600 Analytics
PHASE3COMPLETED
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
Influenza
NCT00310648600
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Study Endpoints

Primary Endpoints

Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Evaluation of the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects
21(-1/+5) days
Evaluation of safety of a single intramuscular injection of influenza vaccine in non elderly adult and elderly subjects
21(-1/+5) days
To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary Endpoints

Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.
To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Influenza vaccineEXPERIMENTAL -
1: Trivalent Seasonal Influenza VaccineEXPERIMENTAL -
2: Adjuvanted Trivalent Seasonal Influenza VaccineEXPERIMENTAL -

Interventions

NameTypeDescription
Influenza vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry Exclusion Criteria: * Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus...

Countries:ChinaItalyFinland
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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about influenza vaccine

What is Influenza Vaccine, Formulation 2008-2009 used for?

Influenza Vaccine, Formulation 2008-2009 is an investigational vaccine being developed for the prevention of influenza, including seasonal influenza. It is designed to elicit an immune response against the influenza virus strains included in the 2008-2009 formulation. The vaccine is intended for use in various age groups, including children, adults, and the elderly.

Who makes Influenza Vaccine, Formulation 2008-2009?

Influenza Vaccine, Formulation 2008-2009 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company has conducted clinical trials to evaluate the safety and immunogenicity of this seasonal influenza vaccine formulation.

What phase is Influenza Vaccine, Formulation 2008-2009 in?

Influenza Vaccine, Formulation 2008-2009 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The development program includes completed Phase 2 and Phase 3 trials, but the overall program is currently categorized as Phase 2, with no active trials ongoing.

What clinical trials is Influenza Vaccine, Formulation 2008-2009 in?

Influenza Vaccine, Formulation 2008-2009 has been studied in three completed clinical trials. These include NCT00310648, a Phase 3 trial in elderly subjects in China; NCT00316628, a Phase 2 trial in adults aged 65 and over in Italy; and NCT00408395, a Phase 2 trial in children in Finland. A fourth trial, NCT00748813, evaluated the 2008/2009 strain composition in healthy adults.

How does Influenza Vaccine, Formulation 2008-2009 work?

Influenza Vaccine, Formulation 2008-2009 works by presenting inactivated influenza virus surface antigens to the immune system. This exposure triggers the production of antibodies that recognize and neutralize the specific influenza virus strains included in the vaccine formulation. The vaccine is designed to provide protection against seasonal influenza infection by priming the immune system to respond rapidly upon exposure.