Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly


Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Source Sanofi
Brief Summary

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

Overall Status Completed
Start Date 2006-06-01
Completion Date 2009-03-01
Primary Completion Date 2008-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine 21 Days post-vaccination
Enrollment 600

Intervention Type: Biological

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

Description: 0.5mL, Intramuscular

Arm Group Label: Study Group 1

Intervention Type: Biological

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

Description: 0.5mL, Intramuscular

Arm Group Label: Study Group 2



Inclusion Criteria : - Aged over 18 years on the 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 and at least 4 weeks after to 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 - 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 within the past 3 months - Any vaccination within 4 weeks prior to the first trial vaccination - Vaccination planned within 4 weeks after 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.



Minimum Age:

18 Years

Maximum Age:


Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director Sanofi Pasteur Inc
| Ghent, Belgium
| Leuven, Belgium
| Wilrijk, Belgium
| Oxford, United Kingdom
Location Countries


United Kingdom

Verification Date


Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Study Group 1

Type: Experimental

Description: Vaccine with adjuvant

Label: Study Group 2

Type: Experimental

Description: Vaccine without adjuvant

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

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