Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01256931|
Recruitment Status : Unknown
Verified December 2010 by Sahlgrenska University Hospital, Sweden.
Recruitment status was: Recruiting
First Posted : December 9, 2010
Last Update Posted : December 9, 2010
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Observational Model:||Case Control|
|Official Title:||Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.|
|Study Start Date :||December 2010|
|organ transplant patients|
- Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls [ Time Frame: 4 months ]
- Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination [ Time Frame: February 2011 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256931
|Contact: Marie Felldin, MD||+46 31342 10 email@example.com|
|Transplant Institute, Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Västra Götaland, Sweden|
|Contact: Marie Felldin, MD +46 31 342 10 00 firstname.lastname@example.org|
|Principal Investigator:||Vanda Friman, MD, Ph.D||Sahlgrenska University Hospital, Sweden|