Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00383539
First received: September 29, 2006
Last updated: January 10, 2014
Last verified: January 2014

September 29, 2006
January 10, 2014
September 2006
July 2007   (final data collection date for primary outcome measure)
To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine [ Time Frame: 21 Days pot-vaccination ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00383539 on ClinicalTrials.gov Archive Site
To provide information concerning the safety of an inactivated, split-virion influenza vaccine. [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in Adults
Not Provided

The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.

Secondary Objectives:

Immunogenicity

To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers.

To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).

Safety:

To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.

To describe the safety profile after vaccination.

Comfort of the vaccination assessment:

To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection
  • Biological: Inactivated Split-virion influenza vaccine
    Vaccine Lot 1
  • Biological: Inactivated Split-virion influenza vaccine
    Vaccine Lot 2
  • Biological: Inactivated Split-virion influenza vaccine
    Vaccine Lot 3
  • Biological: Inactivated Split-virion influenza vaccine
    Control Vaccine
    Other Name: Vaxigrip
  • Experimental: 1
    Lot 1
    Intervention: Biological: Inactivated Split-virion influenza vaccine
  • Experimental: 2
    Lot 2
    Intervention: Biological: Inactivated Split-virion influenza vaccine
  • Experimental: 3
    Lot 3
    Intervention: Biological: Inactivated Split-virion influenza vaccine
  • Active Comparator: 4
    Control
    Intervention: Biological: Inactivated Split-virion influenza vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2256
December 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria :

  • Aged 18 to 60 years on the 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 at the first visit.

Exclusion Criteria :

  • Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Febrile illness (oral temperature >= 37.5°C, or rectal equivalent temperature >= 38.0°C) on the day of inclusion.
  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • 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.
  • Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion) 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.
  • Blood or blood-derived products received in the past 3 months.
  • Any vaccination in the 4 weeks preceding the trial vaccination.
  • Vaccination planned in the 4 weeks following the trial vaccination.
  • Previous vaccination against influenza (in the previous 6 months).
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Lithuania,   Spain,   United Kingdom
 
NCT00383539
GID23
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