NCT01069601

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: HepNet Study House, German Liverfoundation · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Focetria (2x H1N1 vaccine with MF59 adjuvants)	7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-04-01
• Completion: 2012-04-01
• First posted: 2010-02-17
• Last updated: 2012-04-16

Locations

1 site across 1 country: Germany