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NCT00735020 Clinical Trial

Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00735020
Other study ID # V104P1
Secondary ID
Status Completed
Phase Phase 1
First received August 13, 2008
Last updated January 23, 2014
Start date June 2008
Est. completion date August 2008

Study information
Verified date January 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Adjuvanted Influenza Vaccine
1 dose of Adjuvanted Influenza Vaccine
• Influenza Vaccine
1 dose of Influenza Vaccine

Locations
Country Name City State
Switzerland I.P.A.S. Ligornetto

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome
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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