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

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ClinicalTrials.gov Identifier: NCT00491257
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : January 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Influenza Orthomyxoviridae Infections Biological: Inactivated influenza vaccine (split virion) NH 2007-2008 formulation Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)
Study Start Date : June 2007
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491257


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

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00491257     History of Changes
Other Study ID Numbers: GRT82
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Orthomyxoviridae Infections
Orthomyxoviruses
Split-virion influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs