Regulatory Decision Summary for Influvac Tetra

Authorization was based on data from one pivotal study (Study INFQ3002) with Influvac Tetra (Quadrivalent Inactivated influenza Vaccine [QIV]) and supportive data with Influvac (Trivalent Inactivated influenza Vaccine [TIV]) in children and adolescents. Study INFQ3002 was a randomized, double-blind, active-controlled study in children and adolescents aged 3-17 years. A total of 1,200 subjects (primed and unprimed) were vaccinated (402 subjects with QIV, 404 subjects with TIV[Vic] and 394 subjects with TIV[Yam]). For all 4 strains, noninferiority of QIV to TIV (the primary endpoint) was demonstrated. The superiority of immunogenicity for each of the B-strain lineages in QIV when compared to the TIVs with the alternate B-strain lineage was also demonstrated as the secondary endpoint. Seroconversion based on HI titers was found in more than 60.1% in the QIV group as well as in the TIV groups for all four (shared) strains.

Two lineages of influenza B have been co-circulating during each influenza season across the world with one lineage being predominant over the other in many seasons. By the inclusion of influenza B strains from both lineages, the immunogenicity of QIV is expected to be improved as compared to TIV.

Influvac Tetra is generally well tolerated. Both B strain lineages have been alternatingly present in the marketed trivalent influenza vaccine formulations, and immunogenicity and safety of the two B strain lineages have been extensively studied in clinical studies. A total of 402 subjects aged 3-17 years received QIV in study INFQ 3002. Among them, 269 subjects were 3-8 years of age. In addition, QIV data in adults are also supportive.

Overall, the benefits of Influvac Tetra outweigh the risks for prevention of influenza infection caused by the specific strains contained in the vaccine, in children and adolescents from 3-17 years of age.