Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00457509

Collaborator

(none)

251

Enrollment

Locations

Arms

Duration (Months)

83.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity

Primary Objective:

To describe the safety profile and immunogenicity following each injection.

Condition or Disease	Intervention/Treatment	Phase
Pandemic Influenza Influenza A Virus Infection Orthomyxoviridae Infections	Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant Biological: A/H5N1 inactivated, split-virion influenza vaccine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

251 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Dose 1 with Adjuvant	Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant 0.5 mL, Intramuscular
Experimental: Group 2 Dose 2 with adjuvant	Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant 0.5 mL, Intramuscular
Experimental: Group 3 Dose 3 with adjuvant	Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant 0.5 mL, Intramuscular
Experimental: Group 4 Dose 4 with adjuvant	Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant 0.5 mL, Intramuscular
Active Comparator: Group 5 Control	Biological: A/H5N1 inactivated, split-virion influenza vaccine 0.5 mL, Intramuscular

Outcome Measures

Primary Outcome Measures

To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine [Entire study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria :

Aged 18 to 40 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.

Exclusion Criteria :

Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the present trial period.
Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
Vaccination with an influenza vaccine during the past 6 months
Any vaccination in the 4 weeks preceding the first trial vaccination
Vaccination planned in the 4 weeks following any trial vaccination
Breast-feeding.
For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
Known 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.
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
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.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Blood or blood-derived products received in the past 3 months.
Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)