Back to resultsStudy to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Adjuvanted Influenza Vaccine
Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, vaccine, adjuvants, flu
Eligibility Criteria
Inclusion Criteria:
- Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment
Exclusion Criteria:
- serious medical conditions
- allergies to vaccine components, including but not limited to egg/chicken products
- reduced immune function
- recent use of immunosuppressive therapy
- recent use of influenza vaccine
Sites / Locations
- I.P.A.S.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
Secondary Outcome Measures
To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00735020
Brief Title
Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
Official Title
A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, vaccine, adjuvants, flu
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Adjuvanted Influenza Vaccine
Intervention Description
1 dose of Adjuvanted Influenza Vaccine
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
1 dose of Influenza Vaccine
Primary Outcome Measure Information:
Title
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
Time Frame
36 Days
Secondary Outcome Measure Information:
Title
To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine
Time Frame
36 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment
Exclusion Criteria:
serious medical conditions
allergies to vaccine components, including but not limited to egg/chicken products
reduced immune function
recent use of immunosuppressive therapy
recent use of influenza vaccine
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
I.P.A.S.
City
Ligornetto
ZIP/Postal Code
36 6853
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21906647
Citation
Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.
Results Reference
result
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Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
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