Back to resultsSafety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
Primary Purpose
Influenza Infection
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Subunit influenza vaccine
Adjuvanted influenza vaccine
Adjuvanted influenza vaccine combined with CpG7909
Adjuvanted influenza vaccine combine with CpG7909
Adjuvanted influenza vaccine combine with CpG7909
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Infection focused on measuring Adjuvanted Influenza Vaccine
Eligibility Criteria
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;
Sites / Locations
- Institute for Pharmacokinetic and Analytical Studies
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
Outcomes
Primary Outcome Measures
Measures of humoral immunogenicity for each antigen
Secondary Outcome Measures
Measures of vaccine-induced B and T cell immune responses
Measure of alterated biomarkers and measure of safety
Full Information
NCT ID
NCT00559975
First Posted
November 16, 2007
Last Updated
November 4, 2009
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00559975
Brief Title
Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
Official Title
A Phase 1, Randomized, Controlled, Observer-Blinded, Dose Escalation Study of the Safety, Tolerability and Immunogenicity of a Single Dose of Adjuvanted Influenza Vaccine Combined With CpG7909 in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Infection
Keywords
Adjuvanted Influenza Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Subunit influenza vaccine
Intervention Description
0.5 mL single dose vaccine
Intervention Type
Biological
Intervention Name(s)
Adjuvanted influenza vaccine
Intervention Description
0.5 mL single dose vaccine
Intervention Type
Biological
Intervention Name(s)
Adjuvanted influenza vaccine combined with CpG7909
Intervention Description
0.5 ml influenza vaccine combined with 10 mcg of CpG7909
Intervention Type
Biological
Intervention Name(s)
Adjuvanted influenza vaccine combine with CpG7909
Intervention Description
0.5 mL single dose vaccine combined with 30 mcg of CpG7909
Intervention Type
Biological
Intervention Name(s)
Adjuvanted influenza vaccine combine with CpG7909
Intervention Description
0.5 mL single dose vaccine combined with 100 mcg of CpG7909
Primary Outcome Measure Information:
Title
Measures of humoral immunogenicity for each antigen
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Measures of vaccine-induced B and T cell immune responses
Time Frame
72 hours
Title
Measure of alterated biomarkers and measure of safety
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Institute for Pharmacokinetic and Analytical Studies
City
Ligornetto
ZIP/Postal Code
6853
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine
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