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

NCT ID: NCT00491257

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-07-31

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.

Conditions

Influenza; Orthomyxoviridae Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Group 1

Participants aged 18 to 60 years at enrollment

Group Type: EXPERIMENTAL

Inactivated influenza vaccine (split virion) NH 2007-2008 formulation

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Study Group 2

Participants aged 61 years or older at enrollment.

Group Type: EXPERIMENTAL

Inactivated influenza vaccine (split virion) NH 2007-2008 formulation

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Inactivated influenza vaccine (split virion) NH 2007-2008 formulation

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Vaxigrip

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Edinburgh, , United Kingdom

London, , United Kingdom

Countries

United Kingdom

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

GRT82

Identifier Type: -

Identifier Source: org_study_id