Reducing the Burden of Influenza After Solid-Organ Transplantation

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

619

Participants

Timeline

Start Date

October 26, 2018

Primary Completion Date

August 15, 2020

Study Completion Date

August 15, 2020

Conditions
InfluenzaOrgan Transplantation
Interventions
BIOLOGICAL

High-dose influenza vaccine

The experimental intervention consists in an intramuscular injection of a MF59-adjuvanted trivalent inactivated influenza vaccine containing 15 µg of antigen per strain (Fluad®) or an intramuscular injection of trivalent inactivated influenza vaccine containing 60 µg of antigen per strain (Fluzone-HD®) and will be performed at day 0.

BIOLOGICAL

MF59-adjuvanted influenza vaccine

The experimental intervention consists in an intramuscular injection of a MF59-adjuvanted trivalent inactivated influenza vaccine containing 15 µg of antigen per strain (Fluad®) or an intramuscular injection of trivalent inactivated influenza vaccine containing 60 µg of antigen per strain (Fluzone-HD®) and will be performed at day 0.

BIOLOGICAL

Standard intramuscular influenza vaccine

The control intervention consists in an intramuscular injection of one dose of VaxigripTetra®, the standard non-adjuvanted intramuscular influenza vaccine (as routinely done).

Trial Locations (9)

1011

CHUV, Lausanne

1205

Hopitaux Universitaires de Genève, Geneva

3010

University Hospital Bern, Bern

4031

University Hospital Basel, Basel

6900

Epatocentro Ticino, Lugano

7000

Cantonal Hospital Chur, Chur

8091

UniversitätsSpital Zürich, Zurich

9007

Canton Hospital St-Gallen, Sankt Gallen

41013

Hospitales Universitarios Virgen del Rocio, Seville

All Listed Sponsors
lead

Oriol Manuel

OTHER

collaborator

University Hospital, Basel, Switzerland

OTHER

collaborator

University of Bern

OTHER

collaborator

University Hospital, Geneva

OTHER

collaborator

University of Zurich

OTHER

collaborator

Cantonal Hospital of St. Gallen

OTHER

collaborator

Fondazione Epatocentro Ticino

OTHER

collaborator

Cantonal Hospital Chur

UNKNOWN

collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

NCT03699839 - Reducing the Burden of Influenza After Solid-Organ Transplantation | Biotech Hunter | Biotech Hunter