Influenza Clinical Trial
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.
Verified date | January 2014 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.
Status | Completed |
Enrollment | 72 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 39 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Switzerland | I.P.A.S. | Ligornetto |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
Switzerland,
Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59(®)-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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers. | 36 Days | Yes | |
Secondary | To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine | 36 Days | No |
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