Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

NCT ID: NCT01298102

Last Updated: 2011-02-17

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

PHASE4

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There is no data concerning the immunogenicity nor the security of the adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the effects of this vaccine on transplanted and hemodialyzed patients.

Detailed Description

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The serologic responses to the Pandemrix vaccine will assess the efficacy, with the determination of the seroconversion rate among the patients.

The anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.

Conditions

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Decreased Immunologic Activity [PE] Influenza Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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influenza vaccine

Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls

Group Type EXPERIMENTAL

Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

Intervention Type BIOLOGICAL

intramuscular injection of 1 dose vaccine

Interventions

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Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

intramuscular injection of 1 dose vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Pandemrix

Eligibility Criteria

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Inclusion Criteria

1. Adult patients
2. Haemodialyzed patients
3. Renal transplant recipients who have stable renal function for the last 3 months

Exclusion Criteria

1. No pneumonia or severe infection during 1 month before vaccination
2. No Ivig (intravenous immunoglobulins) treatment during the last 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hospital Erasme

Principal Investigators

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Daniel Abramowicz, PhD

Role: STUDY_DIRECTOR

Hospital Erasme

Locations

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Hospital Erasme

Brussels, Brabant, Belgium

Site Status

Countries

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Belgium

References

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Candon S, Thervet E, Lebon P, Suberbielle C, Zuber J, Lima C, Charron D, Legendre C, Chatenoud L. Humoral and cellular immune responses after influenza vaccination in kidney transplant recipients. Am J Transplant. 2009 Oct;9(10):2346-54. doi: 10.1111/j.1600-6143.2009.02787.x. Epub 2009 Jul 28.

Reference Type BACKGROUND
PMID: 19656126 (View on PubMed)

Other Identifiers

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Etude 2009/INT044

Identifier Type: -

Identifier Source: org_study_id

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