Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
June 16, 2015 updated by: Sanofi Pasteur, a Sanofi Company
Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated Either With an Inactivated Influenza Vaccine Administered Via the Intradermal Route or an Inactivated Influenza Vaccine Administered Via the Intramuscular Route
To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.
Objectives:
- To describe the immune response per age group and vaccine group after vaccination.
- To describe the safety of the vaccines per age group and per vaccine group after vaccination.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
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
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Lyon Sud, France
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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 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria :
- Aged 18 to 40 years (adults) or 60 to 85 years (elderly)
- Provision of a signed informed consent
- Able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until 4 weeks after vaccination
- Entitlement to national social security.
Exclusion Criteria :
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test
- Breast-feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Current alcohol abuse or drug addiction, which may interfere with the subject's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
- Previous vaccination against Influenza in the previous 6 months
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (oral temperature >=37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Study Group 1
Adult, age 18 to 40 years
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0.1 mL, Intradermal
0.5 mL, Intramuscular
Other Names:
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Experimental: Study Group 2
Adult, age 18 to 40 years
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0.1 mL, Intradermal
0.5 mL, Intramuscular
Other Names:
|
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Experimental: Study Group 3
Elderly, age 60 to 85 years
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0.1 mL, Intradermal
0.5 mL, Intramuscular
Other Names:
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Experimental: Study Group 4
Elderly, age 60 to 85 years
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0.1 mL, Intradermal
0.5 mL, Intramuscular
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To provide information concerning immune response to an inactivated, split-virion, influenza vaccine.
Time Frame: 21 days post-vaccination
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21 days post-vaccination
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To provide information concerning the safety of inactivated, split-virion, influenza vaccine.
Time Frame: 21 days post-vaccination and entire study duration
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21 days post-vaccination and entire study duration
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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.
Helpful Links
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
September 1, 2007
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
October 17, 2008
First Submitted That Met QC Criteria
October 17, 2008
First Posted (Estimate)
October 21, 2008
Study Record Updates
Last Update Posted (Estimate)
June 17, 2015
Last Update Submitted That Met QC Criteria
June 16, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GID25
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.