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

Sponsors

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Source Sanofi
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.

Overall Status Completed
Start Date 2007-01-01
Completion Date 2010-09-01
Primary Completion Date 2009-11-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine Entire study period
Enrollment 251
Condition
Intervention

Intervention Type: Biological

Intervention Name: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Description: 0.5 mL, Intramuscular

Arm Group Label: Group 1

Intervention Type: Biological

Intervention Name: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Description: 0.5 mL, Intramuscular

Arm Group Label: Group 2

Intervention Type: Biological

Intervention Name: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Description: 0.5 mL, Intramuscular

Arm Group Label: Group 3

Intervention Type: Biological

Intervention Name: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

Description: 0.5 mL, Intramuscular

Arm Group Label: Group 4

Intervention Type: Biological

Intervention Name: A/H5N1 inactivated, split-virion influenza vaccine

Description: 0.5 mL, Intramuscular

Arm Group Label: Group 5

Eligibility

Criteria:

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

40 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director Sanofi Pasteur Inc
Location
Facility:
| Brussels, Belgium
| Gent, Belgium
| Leuven, Belgium
Location Countries

Belgium

Verification Date

2014-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Group 1

Type: Experimental

Description: Dose 1 with Adjuvant

Label: Group 2

Type: Experimental

Description: Dose 2 with adjuvant

Label: Group 3

Type: Experimental

Description: Dose 3 with adjuvant

Label: Group 4

Type: Experimental

Description: Dose 4 with adjuvant

Label: Group 5

Type: Active Comparator

Description: Control

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Outcomes Assessor)

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