Reducing the Burden of Influenza after Solid-Organ Transplantation: the STOP-FLU trial

Phase 1

• Conditions: Influenza in solid organ transplant patients; MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1 Level: PT Classification code 10061890 Term: Organ transplant System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-001974-27-ES
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois (CHUV)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 780

Inclusion Criteria

Study participants will be enrolled among =18-year old stable SOT recipients =3 months after transplantation, regularly followed at their respective outpatient clinic at the 7 transplant centers and scheduled to receive the annual influenza vaccine.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 780
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 780

Exclusion Criteria

Candidates will be excluded in case of previous severe reaction or allergy to one of the study vaccines or in case of treatment for acute rejection, among others.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified