Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
January 23, 2014 updated by: Novartis Vaccines
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.
This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ligornetto, Switzerland, 36 6853
- I.P.A.S.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
1 dose of Adjuvanted Influenza Vaccine
|
|
Active Comparator: 2
|
1 dose of Influenza Vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.
Time Frame: 36 Days
|
36 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine
Time Frame: 36 Days
|
36 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
August 13, 2008
First Submitted That Met QC Criteria
August 13, 2008
First Posted (Estimate)
August 14, 2008
Study Record Updates
Last Update Posted (Estimate)
January 24, 2014
Last Update Submitted That Met QC Criteria
January 23, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V104P1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.