Fluarix Vaccine Efficacy

FLUARIX QUADRIVALENT (n=6006) was evaluated for efficacy and immunogenicity in a randomized, observer-blinded, non-influenza vaccine comparator (n=6012), controlled trial conducted in 5 independent cohorts in 13 countries during the 2011-2014 flu seasons. Prevention of any and moderate-severe reverse transcriptase polymerase chain reaction (RT-PCR)-confirmed influenza-like illness (ILI) was determined in healthy infants and children aged 6 through 35 months (mean age: 22 months). Children received 1 or 2 doses (28 days apart) depending on their previous history of influenza vaccination. Episodes of ILI included fever ≥100.4 °F with any of the following: cough, runny nose, nasal congestion, or breathing difficulty. Subjects with RT-PCR (+) influenza A and/or B disease were further classified by adverse influenza infection outcomes of fever >102.2 °F, acute otitis media, lower respiratory tract illness, serious extra-pulmonary complications, ICU hospitalization, or supplemental oxygen required for >8 hours. Non-influenza controls received 2 doses 28 days apart of either pneumococcal 13-valent conjugate vaccine or hepatitis A vaccine based on age or hepatitis A vaccine and varicella vaccine, based on influenza vaccination history. Immune responses were evaluated in sera obtained 28 days following 1 or 2 doses of FLUARIX QUADRIVALENT or the comparator in a subgroup of subjects (n=753 for FLUARIX QUADRIVALENT, n=579 for control).¹