Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.
This is a prospective, randomized, single centre trial in the Queen Mary Hospital. We aim to recruit 400 subjects \[with a minimum of 50 subjects per group\] who would be qualified for the Hospital Authority (HA)/ Centre for Health Protection (CHP) Mass Vaccination Program for 2010/2011 TIV. These patients include all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness (or healthcare workers). Subjects will be randomly assigned into 4 groups: Group 1 (ID1) to receive a single low-dose intradermal injection of 2010/2011 TIV, with a microneedle device. Group 2 (ID2) to receive a single higher low-dose intradermal injection of 2010/2011 TIV with a microneedle device. Group 3 (IM15) to receive a single full-dose (15ug) standard 2010/2011 TIV delivered intramuscularly by conventional needle. Group 4 (INT) to receive a single low-dose intradermal injection of 2010/2011 TIV, with Intanza® needle. The 2010/2011 TIV used will be Fluzone®, Sanofi-Pasteur for group 3 and Intanza®, Sanofi-Pasteur for group 1,2 and 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong, China
seroconversion rate
Seroconversion rate (percentage of subjects with a fourfold increase in antibody titres, providing a minimal post vacination titre of 1:40) on day 21 by TIV 2010/2011 hemagglutination inhibition (HI) between the ID and IM groups
Time frame: day 21
Adverse events
Adverse events secondary to vaccination with different devices
Time frame: 30 minutes post vaccination
Seroprotection rate
percentage of subjects with a post vaccination titre of at least 1:40
Time frame: Day 21
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Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental