Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00457509
First received: April 5, 2007
Last updated: January 10, 2014
Last verified: January 2014

April 5, 2007
January 10, 2014
January 2007
November 2009   (final data collection date for primary outcome measure)
To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine [ Time Frame: Entire study period ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00457509 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults
Not Provided

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity

Primary Objective:

To describe the safety profile and immunogenicity following each injection.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Pandemic Influenza
  • Influenza A Virus Infection
  • Orthomyxoviridae Infections
  • Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
    0.5 mL, Intramuscular
  • Biological: A/H5N1 inactivated, split-virion influenza vaccine
    0.5 mL, Intramuscular
  • Experimental: Group 1
    Dose 1 with Adjuvant
    Intervention: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
  • Experimental: Group 2
    Dose 2 with adjuvant
    Intervention: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
  • Experimental: Group 3
    Dose 3 with adjuvant
    Intervention: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
  • Experimental: Group 4
    Dose 4 with adjuvant
    Intervention: Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
  • Active Comparator: Group 5
    Control
    Intervention: Biological: A/H5N1 inactivated, split-virion influenza vaccine
Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, Leroux-Roels G, Pichon S, Kusters I. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis. 2008 Sep 1;198(5):642-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
September 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria :

  • Aged 18 to 40 years on day of inclusion
  • Informed consent form signed
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, inability to bear a child or negative urine pregnancy test.

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
  • Vaccination with an influenza vaccine during the past 6 months
  • Any vaccination in the 4 weeks preceding the first trial vaccination
  • Vaccination planned in the 4 weeks following any trial vaccination
  • Breast-feeding.
  • For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
  • Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
  • Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Blood or blood-derived products received in the past 3 months.
  • Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
  • Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00457509
GPF01
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc
Sanofi
January 2014

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