NCT01273974

Brief Summary

The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
Last Updated

January 11, 2011

Status Verified

August 1, 2010

Enrollment Period

1 month

First QC Date

January 10, 2011

Last Update Submit

January 10, 2011

Conditions

Hemodialysis Patients

Keywords

intradermal influenza vaccinehemodialysis patients

Outcome Measures

Primary Outcomes (1)

  • vaccine effectiveness

    serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination

    3 months

Study Arms (2)

intradermal influenza vaccine

EXPERIMENTAL
Biological: intradermal influenza vaccine

intramuscular influenza vaccine

ACTIVE COMPARATOR
Biological: intramuscular influenza vaccine

Interventions

intradermal influenza vaccineBIOLOGICAL

0.25ml ,intradermal

intradermal influenza vaccine
intramuscular influenza vaccineBIOLOGICAL

0.5ml,intramuscular

intramuscular influenza vaccine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients under chronic hemodialysis

You may not qualify if:

  • history of flu infection in last month
  • history of flu vaccination in 2009
  • hospitalization in last month
  • taking immune suppressants drugs
  • hemodialysis less than twice weekly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University Of Medical Science

Shiraz, Iran

Location

Study Officials

  • Mohammad mahdi Sagheb

    Shiraz University Of Medical Science

    PRINCIPAL INVESTIGATOR

  • Samira Saeian

    Shiraz University Of Medical Science

    PRINCIPAL INVESTIGATOR

  • Jamshid Roozbeh

    Shiraz University Of Medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

October 1, 2009

Primary Completion

November 1, 2009

Study Completion

February 1, 2010

Last Updated

January 11, 2011

Record last verified: 2010-08

Locations

IR(1)