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A Study of the Immunogenicity and Safety of the 2007-2008 Influenza Vaccine

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier:
First received: June 25, 2007
Last updated: January 16, 2014
Last verified: January 2014

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.

The objectives of the trial are:

  • To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
  • To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.

Condition Intervention Phase
Orthomyxoviridae Infections
Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated). [ Time Frame: 21 Days post-vaccination ]

Enrollment: 130
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1
Participants aged 18 to 60 years at enrollment
Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation
0.5 mL, Intramuscular
Other Name: Vaxigrip
Experimental: Study Group 2
Participants aged 61 years or older at enrollment.
Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation
0.5 mL, Intramuscular
Other Name: Vaxigrip


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria :

  • Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or above (from the day of the 61st birthday) on the day of inclusion
  • 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 at least 4 weeks after vaccination

Exclusion Criteria :

  • For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
  • Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
  • Breast-feeding woman
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or 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 egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or 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 that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months, that 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 3 weeks following the trial vaccination
  • Previous vaccination against influenza in the previous 6 months
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  Contacts and Locations
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Please refer to this study by its identifier: NCT00491257

United Kingdom
Edinburgh, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT00491257     History of Changes
Other Study ID Numbers: GRT82
Study First Received: June 25, 2007
Last Updated: January 16, 2014

Keywords provided by Sanofi:
Orthomyxoviridae Infections
Split-virion influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017