Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
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
1 other identifier
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJune 17, 2015
June 1, 2015
1.4 years
October 17, 2008
June 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To provide information concerning immune response to an inactivated, split-virion, influenza vaccine.
21 days post-vaccination
To provide information concerning the safety of inactivated, split-virion, influenza vaccine.
21 days post-vaccination and entire study duration
Study Arms (4)
Study Group 1
EXPERIMENTALAdult, age 18 to 40 years
Study Group 2
EXPERIMENTALAdult, age 18 to 40 years
Study Group 3
EXPERIMENTALElderly, age 60 to 85 years
Study Group 4
EXPERIMENTALElderly, age 60 to 85 years
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Lyon Sud, France
Related Publications (1)
Nougarede N, Bisceglia H, Rozieres A, Goujon C, Boudet F, Laurent P, Vanbervliet B, Rodet K, Hennino A, Nicolas JF. Nine mug intradermal influenza vaccine and 15 mug intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults. Hum Vaccin Immunother. 2014;10(9):2713-20. doi: 10.4161/hv.29695.
PMID: 25483667RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sanofi Pasteur Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2008
First Posted
October 21, 2008
Study Start
September 1, 2007
Primary Completion
February 1, 2009
Study Completion
April 1, 2009
Last Updated
June 17, 2015
Record last verified: 2015-06