Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
Phase 1
Completed
- Conditions
- Influenza Infection
- Interventions
- Biological: Adjuvanted influenza vaccine combined with CpG7909Biological: Adjuvanted influenza vaccine combine with CpG7909Biological: Subunit influenza vaccineBiological: Adjuvanted influenza vaccine
- Registration Number
- NCT00559975
- Lead Sponsor
- Novartis
- Brief Summary
To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 visit;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Adjuvanted influenza vaccine combined with CpG7909 - 4 Adjuvanted influenza vaccine combine with CpG7909 - 5 Adjuvanted influenza vaccine combine with CpG7909 - 1 Subunit influenza vaccine - 2 Adjuvanted influenza vaccine -
- Primary Outcome Measures
Name Time Method Measures of humoral immunogenicity for each antigen 22 days
- Secondary Outcome Measures
Name Time Method Measures of vaccine-induced B and T cell immune responses 72 hours Measure of alterated biomarkers and measure of safety 72 hours
Trial Locations
- Locations (1)
Institute for Pharmacokinetic and Analytical Studies
🇨🇭Ligornetto, Switzerland