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Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.

NCT ID: NCT01256931

Last Updated: 2010-12-09

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

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Brief Summary

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Organ transplant patients who participated in a retrospective study and received 2009 Pandemrix vaccine during autumn 2009 are included in this study.

The main aim is to determine the H1N1 antibody levels one year after Pandemrix in comparison to healthy controls. The secondary aim is to examine the booster effect of 2010 Fluarix in patients and controls.Side effects to Fluarix vaccine are registered.

Detailed Description

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Organ transplant patients and staff members of the Transplant Institute who were vaccinated 2009 and received 2 doses of 2009 H1N1 influenza vaccine (Pandemrix) will be asked to participate in the study.

Serum samples will be collected approximately one year after completed vaccination with Pandemrix and analysed for haemagglutination -inhibiting antibodies against H1N1.The frequency of individuals with remaining protective titers will be examined.

The same individuals will be vaccinated with Fluarix containing antigen from Influenza A California/7/2009(H1N1, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008. The booster effect will be measured one month later.

Conditions

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Organ Transplantation

Keywords

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2009 H1N1 influenza vaccine, organ transplant patients, booster with Fluarix

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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organ transplant patients

No interventions assigned to this group

healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Cohort number 2: Staff members who were vaccinated with Pandemrix 2009 and written informed consent received

Exclusion Criteria

Patients or controls who are allergic to formaldehyde, gentamycin sulphate or natrium deoxycholate or have other contraindications against to Fluarix vaccination.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sahlgrenska University Hospital

Principal Investigators

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Vanda Friman, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Transplant Institute, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Marie Felldin, MD

Role: CONTACT

Phone: +46 31342 10 00

Email: [email protected]

Facility Contacts

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Marie Felldin, MD

Role: primary

References

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Felldin M, Andersson B, Studahl M, Svennerholm B, Friman V. Antibody persistence 1 year after pandemic H1N1 2009 influenza vaccination and immunogenicity of subsequent seasonal influenza vaccine among adult organ transplant patients. Transpl Int. 2014 Feb;27(2):197-203. doi: 10.1111/tri.12237. Epub 2013 Dec 2.

Reference Type DERIVED
PMID: 24289658 (View on PubMed)

Other Identifiers

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MMV-305

Identifier Type: -

Identifier Source: org_study_id