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Seasonal Flu Vaccine in Adult Transplant Recipients

NCT01258023 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2012-04-16

No results posted yet for this study

Summary

The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered once the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.

Conditions

  • Immunocompromised
  • Transplanted

Interventions

BIOLOGICAL

Fluad 1x

15 µg antigen/strain: * A/California/07/2009 (H1N1) - like strain * A/Perth/16/2009 (H3N2) - like strain * B/Brisbane/60/2008- like strain MF59 adjuvant 9.75µg ai 0.5ml

Sponsors & Collaborators

  • HepNet Study House, German Liverfoundation

    lead NETWORK

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
2010-11-30
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • Germany

Study Locations

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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 NCT01258023 on ClinicalTrials.gov