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Adjuvanted influenza vaccine combined with CpG7909

Phase 1

Influenza Infection | Vaccine | Infectious Disease |Novartis AG|Trials Updated: Nov 5, 2009

Adjuvanted influenza vaccine combined with CpG7909 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2007

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

Adjuvanted influenza vaccine combined with CpG7909 clinical trials

Adjuvanted influenza vaccine combined with CpG7909 · 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 Adjuvanted influenza vaccine combined with CpG7909

What is the adjuvanted influenza vaccine combined with CpG7909?

It is an investigational influenza vaccine developed by Novartis AG that combines a flu vaccine with the adjuvant CpG7909. It is designed to prevent influenza infection. The vaccine was studied in a Phase 1 clinical trial that has been completed.

What is the adjuvanted influenza vaccine combined with CpG7909 used for?

It is being developed for the prevention of influenza infection. The vaccine is intended to stimulate an immune response against influenza virus. It has been tested in a Phase 1 trial in healthy adult volunteers.

Who makes the adjuvanted influenza vaccine combined with CpG7909?

The vaccine is developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the clinical development of this adjuvanted influenza vaccine candidate.

What phase is the adjuvanted influenza vaccine combined with CpG7909 in?

The adjuvanted influenza vaccine combined with CpG7909 is in Phase 1 development. The Phase 1 trial has been completed. It is an investigational vaccine and has not been approved by the FDA.

What clinical trials is the adjuvanted influenza vaccine combined with CpG7909 in?

The vaccine was studied in a single Phase 1 trial, NCT00559975, titled "Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine." The trial enrolled 60 participants in Switzerland and has been completed.