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H1N1sw Vaccine in Adult Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01069601
Recruitment Status : Terminated (End of H1N1 Swine Flu Pandemic)
First Posted : February 17, 2010
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.

Condition or disease Intervention/treatment Phase
Immunocompromised Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
Study Start Date : February 2010
Primary Completion Date : April 2011
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: transplanted adults
male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT
Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)
7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart
Other Name: Focetria(R)


Outcome Measures

Primary Outcome Measures :
  1. The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents. [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration. [ Time Frame: 42 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
  • Patients able to visit the outpatient clinic with a life expectancy of at least one year
  • Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection

Exclusion Criteria:

  • Individuals who received any vaccine within 30 days prior to study entry
  • Individuals who received a H1N1 vaccination less than 6 months prior to the study
  • Influenza diagnosed by a physician within 4 months prior to the study start
  • Pregnant or lactating females
  • History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
Contacts and Locations

Information from the National Library of Medicine

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): NCT01069601


Locations
Germany
Hannover Medical School
Hannover, Germany, 30655
Sponsors and Collaborators
HepNet Study House, German Liverfoundation
Investigators
Principal Investigator: Michael P Manns, Prof Hannover Medical School
More Information

Responsible Party: HepNet Study House, German Liverfoundation
ClinicalTrials.gov Identifier: NCT01069601     History of Changes
Other Study ID Numbers: 2009-017052-27
200910H1N1MHH ( Other Identifier: Hannover Medical School )
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012

Keywords provided by HepNet Study House, German Liverfoundation:
solid organ transplantation
bone marrow transplantation
adults
adults with solid organ transplantation
adults with bone marrow transplantation

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs