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2010/2011 Trivalent Influenza Vaccination

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TIV 2010/2011 influenza vaccine
TIV 2010/2011 influenza vaccine
TIV 2010/2011 influenza vaccine
INT
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The University of Hong Kong, Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

IM15

ID1

ID2

INT

Arm Description

15 mcg TIV 2010/2011 influenza vaccine delivered via intramuscular injection (control)

Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet)

Higher low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet)

Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse events
Adverse events secondary to vaccination with different devices
Seroprotection rate
percentage of subjects with a post vaccination titre of at least 1:40

Full Information

First Posted
February 23, 2011
Last Updated
February 23, 2011
Sponsor
The University of Hong Kong
Collaborators
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01304563
Brief Title
2010/2011 Trivalent Influenza Vaccination
Official Title
Safety and Efficacy of Dose Sparing Intradermal 2010/2011 Trivalent Influenza Vaccination With the Novel Microneedle Delivery Device
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong
Collaborators
Hospital Authority, Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IM15
Arm Type
Active Comparator
Arm Description
15 mcg TIV 2010/2011 influenza vaccine delivered via intramuscular injection (control)
Arm Title
ID1
Arm Type
Active Comparator
Arm Description
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet)
Arm Title
ID2
Arm Type
Active Comparator
Arm Description
Higher low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet)
Arm Title
INT
Arm Type
Active Comparator
Arm Description
Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device
Intervention Type
Biological
Intervention Name(s)
TIV 2010/2011 influenza vaccine
Intervention Description
TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
Intervention Type
Biological
Intervention Name(s)
TIV 2010/2011 influenza vaccine
Intervention Description
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
Intervention Type
Biological
Intervention Name(s)
TIV 2010/2011 influenza vaccine
Intervention Description
Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
Intervention Type
Biological
Intervention Name(s)
INT
Intervention Description
Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental
Primary Outcome Measure Information:
Title
seroconversion rate
Description
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
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events secondary to vaccination with different devices
Time Frame
30 minutes post vaccination
Title
Seroprotection rate
Description
percentage of subjects with a post vaccination titre of at least 1:40
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
The University of Hong Kong, Queen Mary Hospital
City
Hong Kong
State/Province
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

2010/2011 Trivalent Influenza Vaccination

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