H1N1sw Vaccine in Adult Transplant Recipients

NCT01069601 | Terminated Phase 2 DMC

• 2 other identifiers: 2009-017052-27200910H1N1MHH
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunocompromised

Keywords

solid organ transplantation; bone marrow transplantation; adults; adults with solid organ transplantation; adults with bone marrow transplantation

Outcome Measures

Primary Outcomes (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.

  42 days

Secondary Outcomes (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.

  42 days

Study Arms (1)

transplanted adults

EXPERIMENTAL

male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT

Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)

Interventions

Focetria (2x H1N1 vaccine with MF59 adjuvants) BIOLOGICAL

7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart

Also known as: Focetria(R)

transplanted adults

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HepNet Study House, German Liverfoundation: lead

Study Sites (1)

Hannover Medical School

Hanover, 30655, Germany

Location

MeSH Terms

Interventions

focetria

Study Officials

• Michael P Manns, Prof

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 16, 2012

Record last verified: 2012-04

Locations

DE (1)