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

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00343681

Collaborator

(none)

120

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

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 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 or Disease	Intervention/Treatment	Phase
Influenza Orthomyxoviridae Infections	Biological: Inactivated influenza vaccine (split virion)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

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 2006-2007 Formulation (Intramuscular Route)

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: Inactivated influenza vaccine (split virion) 0.5 mL, Intramuscular

Arm

Intervention/Treatment

Experimental: 1

Biological: Inactivated influenza vaccine (split virion)

0.5 mL, Intramuscular

Outcome Measures

Primary Outcome Measures

To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion) [21 Days post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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