MedTrace Logo

H1N1sw Vaccine in Adult Transplant Recipients

NCT01069601 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-04-16

No results posted yet for this study

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

BIOLOGICAL

Focetria (2x H1N1 vaccine with MF59 adjuvants)

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

Sponsors & Collaborators

  • HepNet Study House, German Liverfoundation

    lead NETWORK

Principal Investigators

  • Michael P Manns, Prof · Hannover Medical School

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-04-30
Completion
2012-04-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01069601 on ClinicalTrials.gov