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

NCT01256931 | Unknown

• 1 other identifier: MMV-305
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Organ Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination

  February 2011

Study Arms (2)

organ transplant patients

healthy controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transplant patients at the out-patient clinical ward and staff members of the Transplant Institute, Sahlgrenska University Hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 24289658 DERIVED

Study Officials

• Vanda Friman, MD, Ph.D

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Felldin, MD

CONTACT

+46 31342 10 00; marie.felldin@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 9, 2010
• Study Start: December 1, 2010
• Last Updated: December 9, 2010

Record last verified: 2010-12

Locations

SE (1)