Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in adults aged 18–60 years: Randomized, controlled, Phase III trial

Intanza®9 µg intradermal seasonal influenza vaccine for adults 18 to 59 years of age

“…57 The results confirmed that Intanza 9 μg induces similar immunogenicity as Vaxigrip and that it meets CPMP criteria for all three vaccine strains. The study also showed equivalent immunogenicity of three lots of the ID vaccine.…”

“…This is similar to the frequency with the IM reference (37% to 48%). [55][56][57] Other injection site reactions, including erythema, swelling, induration and pruritus, also generally mild, were more frequent with Intanza 9 μg than with the IM reference. This is not surprising because the inflammatory process induced by ID vaccination occurs just below the skin surface and therefore can be easily seen and felt, whereas with IM vaccination, the inflammatory process begins deep in the muscle.…”

“…One exception was myalgia, which was reported to be more frequent with the IM vaccine in the second phase II 56 and in the phase III study. 57 The most common solicited systemic reaction was headache, which occurred in 14% to 33% of subjects in all trials. Severe systemic reactions were rare, occurring in less than 3% of vaccinees with either the ID or the IM vaccine.…”

“…[55][56][57] No treatment-related serious adverse events microneedle that protrudes 1.5 mm from a depthlimiting tip (Fig. 1).…”

Head-to-head comparison of an intradermal and a virosome influenza vaccine in patients over the age of 60

“…[24][25][26][27][28][29] Despite the higher incidence of injection site reactions, the high satisfaction with intradermal injection system emerged from several studies in young adults and in older people and the good acceptability profile of intradermal vaccine reflects the high willingness to get re-vaccinated in the following season. 16,17,25,30 The present study demonstrated that the immunogenicity of Intanza ® 15 μg intradermal vaccine was superior than that of Inflexal ® V virosomal influenza vaccine, when the immune response was evaluated against circulating strains. Several immune response parameters obtained by using HI and NT assays 1 and 3 mo following vaccination were higher following the administration of Intanza ® 15 μg as compared with the virosomal intramuscular formulation, but the small sample size due to the complexity of the assays and the number of viruses used for the cross-reactivity evaluation did not allow to reach a final conclusion.…”