Femme et Homme
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Extrait
•To evaluate the immunological non-inferiority (in terms of Geometric Mean Titre (GMT) and Seroconversion Rate (SCR)) of D-QIV versus TIV-1 (Fluarix) and TIV-2 in children (3 to 17 years) at 28 days (primed subjects) or 56 days (unprimed subjects) following first vaccination (28 days after completion of the immunization series). Criteria to conclude non-inferiority: •The test of non-inferiority will be based on the analysis of the entire age range in each treatment group. Non-inferiority will be concluded if, for the three strains contained in each TIV formulation: •The upper limit of the two-sided 95% confidence interval (CI) of the GMT ratio (TIV-1 (Fluarix) / D-QIV and TIV-2 / D-QIV) after completion of the vaccination series does not exceed 1.5 and •The upper limit of the two-sided 95% CI for the difference in SCR (TIV-1 (Fluarix) minus D-QIV and TIV-2 minus D-QIV) does not exceed 10% for the three strains contained in each TIV formulation
Critère d'inclusion
- Immunization of female and male children aged 3 to 17 years against influenza