H1N1sw Vaccine in Adult Transplant Recipients

This study has been terminated.
(End of H1N1 Swine Flu Pandemic)
Sponsor:
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation
ClinicalTrials.gov Identifier:
NCT01069601
First received: February 15, 2010
Last updated: April 13, 2012
Last verified: April 2012

February 15, 2010
April 13, 2012
February 2010
April 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01069601 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
H1N1sw Vaccine in Adult Transplant Recipients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Immunocompromised
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)
Experimental: transplanted adults
male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT
Intervention: Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
April 2012
April 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01069601
2009-017052-27, 200910H1N1MHH
Yes
HepNet Study House, German Liverfoundation
HepNet Study House, German Liverfoundation
Not Provided
Principal Investigator: Michael P Manns, Prof Hannover Medical School
HepNet Study House, German Liverfoundation
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP