Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Childre

Conditions: Vaccination of healthy children aged 6 months to 17 years with pandemic Flu H5N1 vaccine (30µgHA+aluminum hydroxide vaccine)

Registration Number: EUCTR2008-005791-27-FI

Lead Sponsor: Sanofi Pasteur SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All Subjects:

1) Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures
2) Completion of vaccination according to the national immunization schedule

Subjects Aged =2 Years to <18 Years:

3) Aged =2 years to <18 years on the day of inclusion.
4) 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.
5) 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:

6) Aged =6 months to <2 years on the day of inclusion.
7) Born at full term of pregnancy (=37 weeks) with a birth weight =2.5 kg.
8) Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations).

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All subjects:

1) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination
2) Planned participation in another clinical trial during the present trial period
3) 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
4) 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
5) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
6) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
7) Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
8) Receipt of any vaccine in the 4 weeks preceding trial vaccination
9) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
10) (Known) Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity
11) Previous vaccination against avian influenza with either the trial vaccine or another vaccine
12) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
13) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
14) Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw

Subjects Aged =2 Years to <18 Years:

15) For a female of child-bearing potential, known pregnancy or positive urine pregnancy test
16) Breast-feeding female
17) 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:

18) History of seizures
19) Febrile illness (temperature =38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment