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Subunit influenza vaccine

Phase 1

Influenza Infection | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Nov 5, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Subunit influenza vaccine · 1 trial · 1 indication

Phase 1 1
NCT00559975Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu VaccineInfluenza Infection
COMPLETED60 Analytics
PHASE1COMPLETED
Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
Influenza InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Measures of humoral immunogenicity for each antigen
22 days

Secondary Endpoints

Measures of vaccine-induced B and T cell immune responses
72 hours
Measure of alterated biomarkers and measure of safety
72 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -

Interventions

NameTypeDescription
Subunit influenza vaccineBIOLOGICAL0.5 mL single dose vaccine
Adjuvanted influenza vaccineBIOLOGICAL0.5 mL single dose vaccine
Adjuvanted influenza vaccine combined with CpG7909BIOLOGICAL0.5 ml influenza vaccine combined with 10 mcg of CpG7909
Adjuvanted influenza vaccine combine with CpG7909BIOLOGICAL0.5 mL single dose vaccine combined with 30 mcg of CpG7909
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects aged 18 to ≤40 years Exclusion Criteria: * Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid. * Abnormal TSH from blood samples collected during the screening...

Countries:Switzerland
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Frequently asked questions about Subunit influenza vaccine

What is Subunit influenza vaccine used for?

Subunit influenza vaccine is used for influenza infection. It is an investigational vaccine being developed by Novartis AG for the prevention of influenza. The vaccine is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials to evaluate its safety and immunogenicity.

Who makes Subunit influenza vaccine?

Subunit 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 vaccine is currently in Phase 1 clinical development for the prevention of influenza infection.

What phase is Subunit influenza vaccine in?

Subunit influenza vaccine is in Phase 1 clinical development. It is an investigational vaccine for influenza infection and is not yet approved for public use. The Phase 1 trial has been completed, and the vaccine is still in the early stages of clinical testing.

What clinical trials is Subunit influenza vaccine in?

Subunit influenza vaccine has been studied in one completed Phase 1 clinical trial, identified as NCT00559975. The trial was titled 'Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine' and enrolled 60 participants in Switzerland. The study was active-controlled and included healthy volunteers aged 18 years and older.

Is Subunit influenza vaccine FDA approved?

Subunit influenza vaccine is not FDA approved. It is an investigational vaccine currently in Phase 1 clinical development for influenza infection. The vaccine has completed one Phase 1 trial, but it has not yet received regulatory approval and remains in clinical testing.