Safety of the Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Healthy Childre

• Conditions: Vaccination of healthy children aged 6 to 35 months and 3 to 8 years (2 doses at a 28 day-interval); Classification code 10036897

• Registration Number: EUCTR2005-002965-35-FI
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 [<2 years] only),
3) Informed consent form signed by the parent(s) or another legal representative (and by an independent witness if required by local regulations),
4) Able to attend all scheduled visits and to comply with all trial procedures,
5) Subject who completed vaccination according to the national immunization schedule.
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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified