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Adjuvanted influenza vaccine combined with CpG7909

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

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 Infection
NCT0055997560
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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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