A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00343681
First received: June 21, 2006
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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 evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency
  • To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.

Condition Intervention Phase
Influenza
Orthomyxoviridae Infections
Biological: Inactivated influenza vaccine (split virion)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 2006-2007 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 inactivated influenza vaccine (split virion) [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Inactivated influenza vaccine (split virion)
0.5 mL, Intramuscular

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged at least 18 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 Visit 1
  • For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.

Exclusion Criteria:

  • Febrile illness (oral temperature >=37.5°C) on the day of vaccination
  • Breast-feeding
  • Participation in another clinical trial in the four 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 six months, or long-term systemic corticosteroids therapy
  • 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
  • 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
  • Blood or blood-derived products received in the past three months
  • Any vaccination in the four weeks preceding the trial vaccination
  • Vaccination planned in the three weeks following the trial vaccination
  • Vaccination against influenza in the previous six 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343681

Locations
Switzerland
Allschwil, Switzerland
United Kingdom
Edinburgh, United Kingdom
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00343681     History of Changes
Other Study ID Numbers: GRT63
Study First Received: June 21, 2006
Last Updated: January 16, 2014
Health Authority: Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi:
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

ClinicalTrials.gov processed this record on July 22, 2014