Intradermal Influenza Vaccine Administered Using a New Microinjection System Produces Superior Immunogenicity in Elderly Adults: A Randomized Controlled Trial

Abstract

Clinicaltrials.gov registry number: NCT00296829.

Immunogenicity of intramuscular MF59-adjuvanted and intradermal administered influenza enhanced vaccines in subjects aged over 60: A literature review

“…Table 2 reports HI antibody responses induced following administration of ID vaccine using BD's Soluvia to volunteers aged 60 y in the 9 different clinical studies considered in the present review. [28][29][30][31]41,[57][58][59][60] In the study by Arnou et al 28 the results over 3 consecutive years were reported and in one study 58 ) only the results for A/H3N2 strain were included. The total number of subjects examined was 5035 for A/H3N2 and 5100 for A/H1N1 and B antigens.…”

“…Although a number of results were available, 2 meta-analysis on IM-MF59 26,27 and 2 randomized controlled trials on ID 28,29 including safety data in adults >60 y of age with and without underlying diseases were identified. These studies included trials comparing IM-MF59 or ID with non-adjuvanted influenza vaccines; however we considered results concerning the 2 potentiated vaccines only.…”

“…However, the majority of solicited reactions were local, and mild or moderate in intensity both after IM-MF59 26,27 and ID. 28,29 Recently, 2 different studies carried out by Van Damme et al 30 and by Scheifele et al 31 directly compared, in addition to immunogenicity, safety and tolerability, of IM-MF59 and ID in the elderly. Adverse events in the first 3 d post-vaccination were similar for the 2 vaccines and symptoms were mild to moderate.…”

Improving seasonal and pandemic influenza vaccines

“…Clinical trial results obtained to date reveal no safety issues with either the 9‐ or the 15‐μg formulation of the intradermal vaccine 29 , 40 . The rates of solicited systemic reactions and unsolicited adverse events observed in each trial performed to date have been comparable between intradermal and intramuscular groups.…”

“…In a phase 2 study, the immunogenicity and safety of two different intradermal vaccine formulations containing 15 or 21 μg of haemagglutinin per strain were compared with that of Vaxigrip ® , which contains 15 μg of haemagglutinin per strain 29 . The study was designed to test whether one or both of the investigational intradermal vaccines induced statistically superior immune responses compared with the control vaccine.…”