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

Influenza Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545701
• Other study ID #: GPA11
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2007
• Last updated: January 10, 2014
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Orthomyxoviridae Infections

Intervention

Biological:
• A/H5N1 inactivated, split-virion influenza virus
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

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine		Day 42 post-vaccination 1	No

External Links

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