2010/2011 Trivalent Influenza Vaccination

This study has been completed.
Sponsor:
Collaborator:
Hospital Authority, Hong Kong
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01304563
First received: February 23, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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


Condition Intervention
Influenza
Biological: TIV 2010/2011 influenza vaccine
Biological: INT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Dose Sparing Intradermal 2010/2011 Trivalent Influenza Vaccination With the Novel Microneedle Delivery Device

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • seroconversion rate [ Time Frame: day 21 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes post vaccination ] [ Designated as safety issue: Yes ]
    Adverse events secondary to vaccination with different devices

  • Seroprotection rate [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    percentage of subjects with a post vaccination titre of at least 1:40


Enrollment: 240
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: ID1
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet)
Biological: TIV 2010/2011 influenza vaccine
Low 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
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304563

Locations
China, Hong Kong
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Hospital Authority, Hong Kong
  More Information

No publications provided

Responsible Party: Dr Ivan FN Hung, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01304563     History of Changes
Other Study ID Numbers: HKU-2010-149
Study First Received: February 23, 2011
Last Updated: February 23, 2011
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014