H1N1sw Vaccine in Adult Transplant Recipients

Sponsor

HepNet Study House, German Liverfoundation (Other)

Overall Status

Terminated

CT.gov ID

NCT01069601

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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

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 :

Feb 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2012

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 Names: Focetria(R)

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 Names:

Focetria(R)

Outcome Measures

Primary Outcome Measures

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. [42 days]

Secondary Outcome Measures

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. [42 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hannover Medical School	Hannover		Germany	30655

Sponsors and Collaborators

HepNet Study House, German Liverfoundation

Investigators

Principal Investigator: Michael P Manns, Prof, Hannover Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HepNet Study House, German Liverfoundation

ClinicalTrials.gov Identifier:

NCT01069601

Other Study ID Numbers:

2009-017052-27
200910H1N1MHH

First Posted:

Feb 17, 2010

Last Update Posted:

Apr 16, 2012

Last Verified:

Apr 1, 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

Study Results

No Results Posted as of Apr 16, 2012