MedDataX Logo

2010/2011 Trivalent Influenza Vaccination

NCT ID: NCT01304563

Last Updated: 2011-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IM15

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

Group Type ACTIVE_COMPARATOR

TIV 2010/2011 influenza vaccine

Intervention Type BIOLOGICAL

TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control

ID1

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

Group Type ACTIVE_COMPARATOR

TIV 2010/2011 influenza vaccine

Intervention Type BIOLOGICAL

Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental

ID2

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

Group Type ACTIVE_COMPARATOR

TIV 2010/2011 influenza vaccine

Intervention Type BIOLOGICAL

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

Group Type ACTIVE_COMPARATOR

INT

Intervention Type BIOLOGICAL

Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TIV 2010/2011 influenza vaccine

TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control

Intervention Type BIOLOGICAL

TIV 2010/2011 influenza vaccine

Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental

Intervention Type BIOLOGICAL

TIV 2010/2011 influenza vaccine

Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental

Intervention Type BIOLOGICAL

INT

Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

The University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HKU-2010-149

Identifier Type: -

Identifier Source: org_study_id