Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
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ClinicalTrials.gov Identifier: NCT00776438 |
Recruitment Status :
Completed
First Posted : October 21, 2008
Last Update Posted : June 17, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza Orthomyxovirus Infections Myxovirus Infection | Biological: Inactivated, split-virion, influenza vaccine Biological: Inactivated, split-virion influenza vaccine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | April 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Study Group 1
Adult, age 18 to 40 years
|
Biological: Inactivated, split-virion, influenza vaccine
0.1 mL, Intradermal |
Experimental: Study Group 2
Adult, age 18 to 40 years
|
Biological: Inactivated, split-virion, influenza vaccine
0.5 mL, Intramuscular
Other Name: Vaxigrip® |
Experimental: Study Group 3
Elderly, age 60 to 85 years
|
Biological: Inactivated, split-virion influenza vaccine
0.1 mL, Intradermal |
Experimental: Study Group 4
Elderly, age 60 to 85 years
|
Biological: Inactivated, split-virion influenza vaccine
0.5 mL, Intramuscular
Other Name: Vaxigrip® |
- To provide information concerning immune response to an inactivated, split-virion, influenza vaccine. [ Time Frame: 21 days post-vaccination ]
- 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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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776438
France | |
Lyon Sud, France |
Study Director: | Medical Monitor | Sanofi Pasteur Inc |
Publications of Results:
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00776438 |
Other Study ID Numbers: |
GID25 |
First Posted: | October 21, 2008 Key Record Dates |
Last Update Posted: | June 17, 2015 |
Last Verified: | June 2015 |
Influenza Orthomyxoviruses Myxovirus Infection |
Inactivated Split-virion influenza vaccine Adults Elderly |
Infection Communicable Diseases Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases |
Respiratory Tract Infections Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |