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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00457509
Other study ID # GPF01
Secondary ID
Status Completed
Phase Phase 1
First received April 5, 2007
Last updated January 10, 2014
Start date January 2007
Est. completion date September 2010

Study information

Verified date January 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 251
Est. completion date September 2010
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Biological:
A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
A/H5N1 inactivated, split-virion influenza vaccine
0.5 mL, Intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine Entire study period Yes
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