NCT01049490

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

January 12, 2010

Last Update Submit

December 13, 2013

Conditions

Influenza Infection

Keywords

Intradermal vaccination, H1N1, microneedle

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate on day 21 as measured by S-OIV H1N1 specific neutralizing antibody (NT) and hemagglutination inhibition (HAI) in the intradermal (ID) and intramuscular (IM) groups

    Day 21

Secondary Outcomes (5)

  • Seroconversion rate day 42

    Day 21 and 42

  • Geometric mean titer increases in antibodies

    Day 21 and 42

  • Specific neutralizing antibody (NT) titre

    Day 21 and 42

  • Seroprotection rate

    Day 21 and 42

  • Adverse events (30 minutes post vaccination period)

    Day 21 and 42

Study Arms (2)

Intramuscular

ACTIVE COMPARATOR

15 mcg H1N1 vaccine delivered via intramuscular injection (control)

Biological: S-OIV H1N1 vaccine

Intradermal

ACTIVE COMPARATOR

Intradermal: H1N1 vaccine delivered via intradermal injection: Experimental

Biological: S-OIV H1N1 vaccine

Interventions

S-OIV H1N1 vaccineBIOLOGICAL

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

IntradermalIntramuscular

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Guangdong, China

Location

Study Officials

  • Ivan FN Hung, MD MRCP

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 14, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

CN(1)