NCT01304563

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

February 25, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

February 23, 2011

Last Update Submit

February 23, 2011

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • 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

    day 21

Secondary Outcomes (2)

  • Adverse events

    30 minutes post vaccination

  • Seroprotection rate

    Day 21

Study Arms (4)

IM15

ACTIVE COMPARATOR

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

Biological: TIV 2010/2011 influenza vaccine

ID1

ACTIVE COMPARATOR

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

Biological: TIV 2010/2011 influenza vaccine

ID2

ACTIVE COMPARATOR

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

Biological: TIV 2010/2011 influenza vaccine

INT

ACTIVE COMPARATOR

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

Biological: INT

Interventions

TIV 2010/2011 influenza vaccineBIOLOGICAL

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

IM15
INTBIOLOGICAL

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

INT

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 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 25, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 25, 2011

Record last verified: 2011-02

Locations

CN(1)