2010/2011 Trivalent Influenza Vaccination

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

Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: TIV 2010/2011 influenza vaccine; Biological: TIV 2010/2011 influenza vaccine; Biological: TIV 2010/2011 influenza vaccine; Biological: INT

Detailed Description

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
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • The University of Hong Kong, Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hospital Authority, Hong Kong

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Estimate): February 25, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: HKU-2010-149