Study of Quadrivalent Influenza Vaccine Among Children

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the
licensed 2010 2011 trivalent influenza vaccine (TIV) containing the primary B strain, and
the investigational TIV containing the alternate B strain in children.

Primary Objective:

To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011
TIV (containing the primary B strain) and investigational TIV (containing the alternate B
strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains
separately among children aged 6 months to less than 9 years of age

Secondary Objective:

To demonstrate superiority of antibody responses to each B strain in QIV compared with
antibody titers following vaccination with the TIV that does not contain the corresponding B
strain, as assessed by GMT ratios and seroconversion rates.

Observational Objective:

To describe the safety profile of QIV among subjects 6 months to less than 9 years of age,
as assessed by solicited injection site and systemic adverse events (AEs) collected for 7
days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination,
and adverse events of special interest and serious adverse events (SAEs) collected from
Visit 1 to Visit 2.