CompletedInterventionalPhase 2Updated Jan 14, 2014
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults | NCT00545701 | Trialant
CompletedInterventionalPhase 2Updated Jan 14, 2014
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
ClinicalTrials.gov ID
NCT00545701
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
100Actual
Last Update Posted
Jan 14, 2014Estimated
Start Date
Oct 2007
Primary Completion Date
Jun 2008Actual
Completion Date
Sep 2008Actual
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.
Influenza
Orthomyxoviridae Infections
A/H5N1 inactivated, split-virion influenza virus
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.