Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00718146

Collaborator

(none)

130

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

21.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP)

Objectives:

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96.
To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.

Condition or Disease	Intervention/Treatment	Phase
Influenza Orthomyxoviridae Infections	Biological: Split virion, inactivated Influenza vaccine Biological: Split virion, inactivated Influenza vaccine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Age 16 to 60 years	Biological: Split virion, inactivated Influenza vaccine 0.5 mL, Intramuscular (IM)
Experimental: Group 2 Age over 60 years	Biological: Split virion, inactivated Influenza vaccine 0.5 mL, Intramuscular (IM)

Arm

Intervention/Treatment

Experimental: Group 1

Age 16 to 60 years

Biological: Split virion, inactivated Influenza vaccine

0.5 mL, Intramuscular (IM)

Experimental: Group 2

Age over 60 years

Biological: Split virion, inactivated Influenza vaccine

0.5 mL, Intramuscular (IM)

Outcome Measures

Primary Outcome Measures

Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated). [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 18 to 60 years or 61 years and older 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 21 days after vaccination

Exclusion Criteria :

For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at visit 01
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, chick proteins, neomycin, formaldehyde and octoxinol 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 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.