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

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00415129

Collaborator

(none)

600

Enrollment

Locations

Arms

Duration (Months)

150

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza Orthomyxoviridae Infections	Biological: A/H5N1 inactivated, split-virion influenza virus Biological: A/H5N1 inactivated, split-virion influenza virus	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Group 1 Vaccine with adjuvant	Biological: A/H5N1 inactivated, split-virion influenza virus 0.5mL, Intramuscular
Experimental: Study Group 2 Vaccine without adjuvant	Biological: A/H5N1 inactivated, split-virion influenza virus 0.5mL, Intramuscular

Arm

Intervention/Treatment

Experimental: Study Group 1

Vaccine with adjuvant

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

0.5mL, Intramuscular

Experimental: Study Group 2

Vaccine without adjuvant

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

0.5mL, Intramuscular

Outcome Measures

Primary Outcome Measures

To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine [21 Days post-vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.