Study of Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00946179
First received: July 22, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

This study is in support of the annual application for the variation of the vaccine strains for a marketing authorization.

Objectives:

  • To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) Northern Hemisphere (NH) 2009-2010 formulation in two adult groups, aged 18 to 60 years and aged 61 years or older.
  • To describe the safety of the influenza vaccine (split virion, inactivated) NH 2009-2010 formulation in both adult groups.

Condition Intervention Phase
Influenza
Biological: Influenza virus (split virion, inactivated) vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 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 intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation. [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • To provide information concerning the safety of intramuscular (IM) Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation [ Time Frame: 0 to 7 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Participants aged 18 to 60 years at enrollment
Biological: Influenza virus (split virion, inactivated) vaccine
0.5 mL, Intramuscular
Other Name: Influenza Vaccine Northern Hemisphere 2009-2010 formulation
Experimental: Group 2
Participants aged 61 years or older at enrollment
Biological: Influenza virus (split virion, inactivated) vaccine
0.5 mL, Intramuscular
Other Name: Influenza Vaccine Northern Hemisphere 2009-2010 formulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 older (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 3 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 ≥ 38 °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 eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, 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
  • Known human immunodeficiency virus (HIV), Hepatitis B surface (HBs) 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
  • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or investigator
  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: NCT00946179

Locations
Switzerland
Allschwil, Switzerland, CH-4123
Zurich, Switzerland, CH-8001
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: NCT00946179     History of Changes
Other Study ID Numbers: GRT86
Study First Received: July 22, 2009
Last Updated: January 16, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Sanofi:
Influenza
Influenza virus vaccine
Split virion

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 October 19, 2014