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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT00776438
• Date of registration: 17/10/2008
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 160
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00776438
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Medical Monitor
• Affiliation: Sanofi Pasteur Inc

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Orthomyxovirus Infections

Myxovirus Infection

Intervention(s)

Biological: Inactivated, split-virion influenza vaccine

Biological: Inactivated, split-virion, influenza vaccine

Primary Outcome(s)

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]

Secondary ID(s)

GID25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors