A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months

This is an interventional prevention trial for Influenza focused on measuring Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Swine-origin Influenza Virus, Infants Read More

Inclusion Criteria :

All subjects

• Aged 6 to 35 months on the day of inclusion
• Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
• Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures
• Completion of vaccination according to the national immunization schedule.

Subjects ≥ 6 to < 24 months of age - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

At Month 8 for antibody persistence assessment:

• Having received two half-doses of either the formulation 1 or 2 of the vaccine
• Addendum 1 to Informed Consent Form has been signed and dated by the parents or other legally acceptable representative.

At Visit 06, for subjects eligible for the Antibody persistence evaluation who will receive the Trivalent Influenza Vaccine (TIV):

- Addendum 2 to Informed Consent Form has been signed by the subject's parents/legal representative.

Exclusion Criteria :

All subjects

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
• Planned participation in another clinical trial during the present trial period
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
• Planned receipt of any vaccine prior to the Day 42 blood sample
• Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
• 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C as reported by parents/legal representative
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
• Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
• Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
• Family members of the employees or the Investigator
• Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
• Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
• Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
• Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)

Subjects ≥ 6 to < 24 months of age - History of seizures

At Month 8, for antibody persistence assessment:

- Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products.