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

• ClinicalTrials.gov Identifier: NCT00776438
• Recruitment Status: Completed
• First Posted: October 21, 2008
• Last Update Posted: June 17, 2015
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

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	Phase 2

Study Design

• 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

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 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®

Outcome Measures

Primary Outcome Measures :

1. To provide information concerning immune response to an inactivated, split-virion, influenza vaccine. [ Time Frame: 21 days post-vaccination ]
2. To provide information concerning the safety of inactivated, split-virion, influenza vaccine. [ Time Frame: 21 days post-vaccination and entire study duration ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

Lyon Sud, France

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Monitor; Sanofi Pasteur Inc

More Information

Additional Information:

Related Info  Related Info 

Publications of Results:

Nougarede N, Bisceglia H, Rozières A, Goujon C, Boudet F, Laurent P, Vanbervliet B, Rodet K, Hennino A, Nicolas JF. Nine μg intradermal influenza vaccine and 15 μg 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.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00776438
• Other Study ID Numbers: GID25
• First Posted: October 21, 2008
• Last Update Posted: June 17, 2015
• Last Verified: June 2015

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Influenza; Orthomyxoviruses; Myxovirus Infection; Inactivated Split-virion influenza vaccine; Adults; Elderly

Additional relevant MeSH terms:

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