Performance and usability evaluation of novel intradermal injection device Immucise™ and reanalysis of intradermal administration trials of influenza vaccine for the elderly

• Published in: Vaccine Vol. 40; no. 6; pp. 873 - 879
• Main Authors: Shimizu, Sakiko, Tanaka, Ryo, Itoh, Eriko, Maekawa-Matsuura, Minami, Iwase, Yoichiro
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 07.02.2022; Elsevier Limited
• Subjects: Aged; Allergy and Immunology; Antibodies, Viral; Clinical trials; COVID-19; Drug delivery device; Drug dosages; elderly; FDA approval; health services; Humans; immunity; Influenza; Influenza Vaccines; Influenza, Human - prevention & control; Injection; Injections, Intradermal - methods; Injections, Intramuscular; Intradermal injection; Laboratories; Older people; pandemic; Pandemics; Performance evaluation; R&D; Research & development; Ultrasonic imaging; vaccination; Vaccination - methods; Vaccine; Vaccines; Japan; EEA; CE; FDA; CDC; IM; CI; Vaccine; GLP; IQR; NIH; GMT; Intradermal injection; SC; HAI; OECD; Drug delivery device; Influenza; Immucise; ID; BMI; WHO; hemagglutination inhibition; Intramuscular; National Institutes of Health; Centers for Disease Control and Prevention; Intradermal; Good Laboratory Practice; Food and Drug Administration; Body Mass Index; World Health Organization; Subcutaneous; European Economic Area; Confidence interval; Immucise™ Intradermal Injection System; Conformité Européenne; Geometric mean titer; Interquartile range; Organisation for Economic Co-operation and Development

Under the pandemic situation, there is an urgent need to produce and acquire sufficient quantities of prophylactic vaccines. It becomes important to devise a way to achieve reliable immunity with lower doses to distribute limited supplies of vaccines to maximum number of people very quickly. Intrade...