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OpenTrials
Completed

NCT Number: NCT00383539

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inactivated Split-virion influenza vaccine

Biological

Vaccine Lot 1

Primary outcomes

  1. To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine

    Time frame: 21 Days pot-vaccination

Secondary outcomes

  1. To provide information concerning the safety of an inactivated, split-virion influenza vaccine.

    Time frame: 6 months post-vaccination

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 3, 2006
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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