Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00545701

Collaborator

(none)

100

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.

Objectives:

To describe the immune response 21 days after each vaccination.
To describe the safety profiles following each vaccination.

Condition or Disease	Intervention/Treatment	Phase
Influenza Orthomyxoviridae Infections	Biological: A/H5N1 inactivated, split-virion influenza virus	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: A/H5N1 inactivated, split-virion influenza virus 0.5 mL, Intramuscular

Arm

Intervention/Treatment

Experimental: 1

Biological: A/H5N1 inactivated, split-virion influenza virus

0.5 mL, Intramuscular

Outcome Measures

Primary Outcome Measures

To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine [Day 42 post-vaccination 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 18 to 60 years on 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.
For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.

Exclusion Criteria:

Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
Breast-feeding.
Previous vaccination with an avian flu vaccine.
Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
Current alcohol or drug abuse 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 first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
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.