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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00776438
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):

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
Primary Completion Date : February 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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

Information from the National Library of Medicine

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


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:
Publications:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00776438     History of Changes
Other Study ID Numbers: GID25
First Posted: October 21, 2008    Key Record Dates
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