Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00776438

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza Orthomyxovirus Infections Myxovirus Infection	Biological: Inactivated, split-virion, influenza vaccine Biological: Inactivated, split-virion, influenza vaccine Biological: Inactivated, split-virion influenza vaccine Biological: Inactivated, split-virion influenza vaccine	Phase 2

Study Design

Study Type:

Interventional

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 :

Sep 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

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 Names: 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 Names: Vaxigrip®

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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