The Immunogenicity of Intradermal Influenza Vaccination i... | NCT01273974

Studies
The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

NCT01273974

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Jan 11, 2011Estimated

Enrollment

130Actual

Phase

Phase 2Phase 3

Conditions

Hemodialysis Patients

Interventions

intradermal influenza vaccine
intramuscular influenza vaccine

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jan 10, 2011

First Submission Date that Met QC Criteria

Jan 10, 2011

First Posted Date

Jan 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients.

In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intradermal influenza vaccine	Experimental		Biological: intradermal influenza vaccine
intramuscular influenza vaccine	Active Comparator		Biological: intramuscular influenza vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intradermal influenza vaccine	Biological	0.25ml ,intradermal	intradermal influenza vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vaccine effectiveness	serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients under chronic hemodialysis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz University Of Medical Science		Shiraz			Iran