2010/2011 Trivalent Influenza Vaccination

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304563
• Other study ID #: HKU-2010-149
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: February 23, 2011
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• TIV 2010/2011 influenza vaccine
TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
• TIV 2010/2011 influenza vaccine
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
• TIV 2010/2011 influenza vaccine
Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
• INT
Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental

Locations

Country	Name	City	State
China	The University of Hong Kong, Queen Mary Hospital	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events	Adverse events secondary to vaccination with different devices	30 minutes post vaccination	Yes
Secondary	Seroprotection rate	percentage of subjects with a post vaccination titre of at least 1:40	Day 21	No