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

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviridae Infections
• Interventions: Biological: A/H5N1 inactivated, split-virion influenza virus

• Registration Number: NCT00545701
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-17
• Primary Completion: 2008-06
• Study Completion: 2008-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	A/H5N1 inactivated, split-virion influenza virus	-

Primary Outcome Measures

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