Influenza Clinical Trial
Official title:
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children
Verified date | January 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
This study is part of an effort to develop an effective vaccination program in children in
the event of a pandemic.
Study objectives:
- To describe the safety profiles in the periods following each vaccination in subjects
receiving different vaccination schedule.
- To describe the immune response after each vaccination in subjects receiving study
vaccine.
Status | Completed |
Enrollment | 350 |
Est. completion date | June 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 17 Years |
Eligibility |
Inclusion Criteria : All Subjects - Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures. - Completion of vaccination according to the national immunization schedule Subjects Aged = 2 Years to < 18 Years: - Aged = 2 years to < 18 years on the day of inclusion. - Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 11 years, and of Informed Consent Form signed by subjects = 12 years. - For a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination. Subjects Aged = 6 Months to < 2 Years: - Aged = 6 months to < 2 years on the day of inclusion. - Born at full term of pregnancy (= 37 weeks) with a birth weight = 2.5 kg. - Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations). Exclusion Criteria : All subjects - Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination - Planned participation in another clinical trial during the present trial period - Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy - Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances - Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator - Current alcohol abuse or drug addiction 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 trial vaccination - Planned receipt of any vaccine in the 4 weeks following any trial vaccination - (Known) Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity - Previous vaccination against avian influenza with either the trial vaccine or another vaccine - Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination - Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent - Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw Subjects Aged =2 Years to <18 Years: - For a female of child-bearing potential, known pregnancy or positive urine pregnancy test - Breast-feeding female - Febrile illness (temperature = 37.5 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment Subjects Aged = 6 Months to < 2 Years: - History of seizures - Febrile illness (temperature = 38 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine. | 21 days post-vaccination and entire study | Yes | |
Secondary | To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine. | 21 days post-vaccination | No |
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