Clinical trial NCT00545701: Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Orthomyxoviridae Infections
Keywords: Influenza
A/H5N1 strain
Orthomyxoviridae Infections
Influenza Pandemics
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
timeFrame: Day 42 post-vaccination 1
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Queensland
country: Australia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: