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

Pandemic Influenza Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457509
• Other study ID #: GPF01
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza A Virus Infection
• Influenza, Human
• Orthomyxoviridae Infections
• Pandemic Influenza
• Virus Diseases

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

External Links

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