Extrait

•To assess the immunogenicity of FLU Q-QIV based on Center for Biologics Evaluation and Research’s (CBER)’s Seroconversion Rate (SCR) criterion for each of the four strains in children 6 to 35 months of age, approximately 28 days after completion of dosing (approximately Day 28 and Day 56 for primed and unprimed subjects, respectively). Criterion for determination of effective immunisation: The lower limit of the two-sided 95% confidence interval (CI) for SCR should be ≥ 40% for each strain. •To describe the reactogenicity of FLU Q-QIV and Fluarix in terms of solicited local and general adverse events (AEs), during a 7-day follow-up period.

Critère d'inclusion

• Healthy volunteers (immunisation against influenza in male and female subjects 6 to 35 months of age inclusive)

Liens

• euctr