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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
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 17, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date June 17, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00776438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Influenza
  • Orthomyxovirus Infections
  • Myxovirus Infection
Intervention  ICMJE
  • Biological: Inactivated, split-virion, influenza vaccine
    0.1 mL, Intradermal
  • Biological: Inactivated, split-virion, influenza vaccine
    0.5 mL, Intramuscular
    Other Name: Vaxigrip®
  • Biological: Inactivated, split-virion influenza vaccine
    0.1 mL, Intradermal
  • Biological: Inactivated, split-virion influenza vaccine
    0.5 mL, Intramuscular
    Other Name: Vaxigrip®
Study Arms  ICMJE
  • Experimental: Study Group 1
    Adult, age 18 to 40 years
    Intervention: Biological: Inactivated, split-virion, influenza vaccine
  • Experimental: Study Group 2
    Adult, age 18 to 40 years
    Intervention: Biological: Inactivated, split-virion, influenza vaccine
  • Experimental: Study Group 3
    Elderly, age 60 to 85 years
    Intervention: Biological: Inactivated, split-virion influenza vaccine
  • Experimental: Study Group 4
    Elderly, age 60 to 85 years
    Intervention: Biological: Inactivated, split-virion influenza vaccine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2008)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776438
Other Study ID Numbers  ICMJE GID25
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP