Status:
COMPLETED
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Orthomyxoviridae Infections
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00884182
Start Date
April 1 2009
End Date
June 1 2010
Last Update
January 14 2014
Active Locations (13)
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1
Espoo, Finland, FIN-02100
2
Helsinki, Finland, FIN-00100
3
Helsinki, Finland, FIN-00930
4
Jarvenpaa, Finland, FIN-04400