2010/2011 Trivalent Influenza Vaccination

Study Overview
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Brief Summary
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Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.

Detailed Description
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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.

Official Title
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Safety and Efficacy of Dose Sparing Intradermal 2010/2011 Trivalent Influenza Vaccination With the Novel Microneedle Delivery Device

Conditions
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Influenza

Intervention / Treatment
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* Biological: TIV 2010/2011 influenza vaccine
* Biological: TIV 2010/2011 influenza vaccine
* Biological: TIV 2010/2011 influenza vaccine
* Biological: INT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants qualified for the HA/ CHP Mass Vaccination Program for TIV 2010/2011 seasonal influenza as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above that are either healthcare workers or that have a chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure. All patients give written informed consent. Subjects must be available to complete the study and comply with study procedures. Exclusion Criteria: Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers. History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months. Have an active neoplastic disease or a history of any hematologic malignancy. Have known active human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection or autoimmune hepatitis and cirrhosis. History of progressive or severe neurological disorders or Guillain-Barré Syndrome.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IM15<br>15 mcg TIV 2010/2011 influenza vaccine delivered via intramuscular injection (control) | Biological: TIV 2010/2011 influenza vaccine<br>* TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control<br>|
| Active Comparator: ID1<br>Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet) | Biological: TIV 2010/2011 influenza vaccine<br>* Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental<br>|
| Active Comparator: ID2<br>Higher low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet) | Biological: TIV 2010/2011 influenza vaccine<br>* Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental<br>|
| Active Comparator: INT<br>Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device | Biological: INT<br>* Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events secondary to vaccination with different devices | 30 minutes post vaccination | 
| Seroprotection rate | percentage of subjects with a post vaccination titre of at least 1:40 | Day 21 |