Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults

Abstract

Since the mid-1980s, two lineages of influenza B viruses have been distinguished. These can co-circulate, limiting the protection provided by inactivated trivalent influenza vaccines (TIVs). This has prompted efforts to formulate quadrivalent influenza vaccines (QIVs), to enhance protection against circulating influenza B viruses. This review describes the results obtained from seven phase III clinical trials evaluating the immunogenicity, safety, and lot-to-lot consistency of a new quadrivalent split-virion influenza vaccine (Vaxigrip Tetra®) formulated by adding a second B strain to the already licensed TIV. Since Vaxigrip Tetra was developed by means of a manufacturing process strictly related to that used for TIV, the data on the safety profile of TIV are considered supportive of that of Vaxigrip Tetra. The safety and immunogenicity of Vaxigrip Tetra were similar to those of the corresponding licensed TIV. Moreover, the new vaccine elicits a superior immune response towards the additional strain, without affecting immunogenicity towards the other three strains. Vaxigrip Tetra is well tolerated, has aroused no safety concerns, and is recommended for the active immunization of individuals aged ≥6 months. In addition, preliminary data confirm its immunogenicity and safety even in children aged 6–35 months and its immunogenicity in older subjects (aged 66–80 years).

How to assess the effectiveness of nasal influenza vaccines? Role and measurement of sIgA in mucosal secretions

“…However, these assays cannot be properly applied to intranasal vaccines, which mainly induce local immune responses (rev. in).…”

The use of cell-mediated immunity for the evaluation of influenza vaccines: an upcoming necessity

“…In the US, the same criteria are used by Food and Drug Administration (FDA), but the lower boundary of the 95% confidence interval (CI) has to be higher than or equal to that of the SCR and geometric mean titer (GMT) criteria. 17 At least one of the 3 criteria must be met by seasonal influenza vaccines, and all 3 criteria by pandemic influenza vaccines in order to be licensed.…”

“…[rev. in 17,23,28 ]. However, the biological role in establishing protection of titers higher than 1:40 remains to be elucidated.…”

Optimizing Neonatal and Maternal Vaccination for Reducing Infant Morbidity and Mortality - A Short Communication

“…Neonatal and Maternal Vaccination for Reducing Infant Morbidity and Mortality -A Short Communicationfor active immunization of individuals aged >6mths. In addition, preliminary data conform its immunogenicity and safety even in children aged 6-35mthas and its immunogenicity in older subjects (aged 66-80 years)[11].Immunizing pregnant women is a promising strategy to de-crease infectious disease related morbidity and mortality in pregnant women and their infants. Important prerequisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient numbers of healthcare workers to deliver the vaccines ;close integration of immunization programs with antenatal care by pregnant women in the country (especially in low and middle income countries (LMIC);and a high proportion of births occurring in health facilities (for ensuring maternal and neonatal follow up can be done).…”