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NCT01256931 Clinical Trial

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

Organ Transplantation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01256931
Other study ID # MMV-305
Secondary ID
Status Recruiting
Phase N/A
First received December 7, 2010
Last updated December 8, 2010
Start date December 2010

Study information
Verified date December 2010
Source Sahlgrenska University Hospital, Sweden
Contact Marie Felldin, MD
Phone +46 31342 10 00
Email marie.felldin@vgregion.se
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 110
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria Cohort number 1: Organ transplant patients who were vaccinated with Pandemrix 2009 and written informed consent received

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Transplant Institute, Sahlgrenska University Hospital Gothenburg Västra Götaland

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls 4 months No
Secondary Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination February 2011 Yes
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