Vaccination of healthy children aged 6 to 35 months and 3 to 8 years (2 doses at a 28 day-interval) Classification code 10036897
Conditions
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 6 months to 8 years on the day of inclusion, 2) Born at full term of pregnancy (>37 weeks) with a birth weight = 2.5 kg (infants and toddlers [=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Febrile illness (rectal equivalent temperature = 38.0°C on the day of inclusion), 2) Participation in another clinical trial in the four weeks preceding the first trial vaccination, 3) Planned participation in another clinical trial during the present trial period, 4) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy, 5) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances, 6) Chronic illness at a stage that could interfere with trial conduct or completion, 7) Blood or blood-derived products received in the past three months, 8) Previous vaccination against influenza with the trial vaccine or another vaccine, 9) Any vaccination in the four weeks preceding the first trial vaccination, 10) Vaccination planned in the four weeks following the trial vaccinations, 11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination, 12) History of seizures (Infants and toddlers [<2 years] only).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Safety after the first vaccination: Occurrence, time to onset, number of days of occurrence, severity of solicited (prelisted in the subject diary and Case Report Form [CRF]) injection site reactions and systemic reactions occurring up to 7 days after the first vaccination. Occurrence, nature ([MedDRA preferred term), time to onset, duration, severity, action taken and relationship (for systemic events only) to vaccination of unsolicited (spontaneously reported) adverse events (AEs) up to 28 days after the first vaccination. - Safety after the second vaccination: The endpoints will be the same as above. Additionally, occurrence and type of injection site reactions observed at the first vaccination site will be assessed (for a same subject the two study vaccinations will not be performed on the same side). - SAE The occurrence, nature, time to onset, duration, severity and relationship to vaccination of serious adverse events (SAEs) during the whole study period will be reported. ;Main Objective: To describe the safety of the 9µg formulation of the inactivated, split-virion influenza vaccine administered by the intradermal (ID) route in children aged 6 to 35 months and 3 to 8 years.;Secondary Objective: To describe the immune response of the 9 µg formulation of the inactivated, split-virion influenza vaccine administered by the ID route 28 days after each vaccination in children aged 6 to 35 months and 3 to 8 years. | — |
Countries
Finland
Outcome results
None listed