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Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device

NCT ID: NCT01049490

Last Updated: 2013-12-16

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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Primary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1 vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the full-dose standard IM injection.

Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular (IM) vaccine.

Detailed Description

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This is a prospective randomised, single-blinded trial in Queen Mary Hospital. We aim to recruit 200 subjects \[with a minimum of 80 subjects per age group (21-65 with chronic diseases and age 65+)\] who would be qualified for the Hospital Authority (HA)/ Centre for Health Protection (CHP) Mass Vaccination Program for S-OIV H1N1. 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. Subjects will be randomly assigned to receive either the full-dose (1 dose) standard Panenza vaccine at day 0 (15ug non-adjuvanted monovalent influenza A(H1N1) 2009 vaccine) delivered intramuscularly using a conventional needle (IM group) or a low-dose (1 dose) intradermal injection of Panenza vaccine at day 0 (3ug non-adjuvanted monovalent influenza A(H1N1) 2009 vaccine) delivered with the MicronJet600 (ID group).

Conditions

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Influenza Infection

Keywords

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Intradermal vaccination, H1N1, microneedle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intramuscular

15 mcg H1N1 vaccine delivered via intramuscular injection (control)

Group Type ACTIVE_COMPARATOR

S-OIV H1N1 vaccine

Intervention Type BIOLOGICAL

Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional

Intradermal

Intradermal: H1N1 vaccine delivered via intradermal injection: Experimental

Group Type ACTIVE_COMPARATOR

S-OIV H1N1 vaccine

Intervention Type BIOLOGICAL

Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional

Interventions

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S-OIV H1N1 vaccine

Intramuscular: 15 mcg H1N1 vaccine: Control Intradermal: 3 mcg S-OIV H1N1 vaccine: Interventional

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* All participants qualified for the HA/ CHP Mass Vaccination Program for S-OIV H1N1 as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above with 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.
* Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria

* Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers.
* Inability to comprehend and to follow all required study procedures.
* 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 received an S-OIV H1N1 vaccination.
* Have a recent (starting May 2009) history (documented, confirmed or suspected) of a flu-like disease).
* 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 a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
* Female of childbearing potential, not using any acceptable contraceptive methods for at least 2 months prior to study entry or that do not plan to use acceptable birth control.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr Ivan FN Hung

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan FN Hung, MD MRCP

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong, Queen Mary Hospital

Hong Kong, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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HKU-2009-128

Identifier Type: -

Identifier Source: org_study_id