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

Reducing the Burden of Influenza after Solid-Organ Transplantation: the STOP-FLU trial [Swiss Trial in solid Organ transplantation on Prevention of inFLUenza] - STOP-FLU

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001974-27-ES

Enrollment

780

Registered

2019-08-09

Start date

2019-10-15

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: VaxigripTetra® Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: A/Michigan/45/2015 (H1N1)pdm09: (NYMC X-275)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the immunogenicity of two novel vaccination strategies, consisting in vaccination with a high dose influenza vaccine or an MF59a influenza vaccine, to the standard-dose non-adjuvanted vaccination (standard of care) in a population of solid-organ transplant recipients. ;Secondary Objective: To evaluate the efficacy of the novel vaccination strategies in reducing the incidence of influenza, to correlate the humoral responses to vaccination with protection from influenza and to assess the influence of immunosuppression on influenza vaccine responses.;Primary end point(s): The primary outcome will be the seroconversion rate at day 28, defined as the proportion of patients with at least a fourfold increase in hemagglutination inhibition assay (HIA) titers for at least one of the 3 vaccine strains included in the trivalent vaccine.;Timepoint(s) of evaluation of this end point: The primary outcome will be the seroconversion rate at day 28.	—

Measure

Time frame

Main Objective: To compare the immunogenicity of two novel vaccination strategies, consisting in vaccination with a high dose influenza vaccine or an MF59a influenza vaccine, to the standard-dose non-adjuvanted vaccination (standard of care) in a population of solid-organ transplant recipients. ;Secondary Objective: To evaluate the efficacy of the novel vaccination strategies in reducing the incidence of influenza, to correlate the humoral responses to vaccination with protection from influenza and to assess the influence of immunosuppression on influenza vaccine responses.;Primary end point(s): The primary outcome will be the seroconversion rate at day 28, defined as the proportion of patients with at least a fourfold increase in hemagglutination inhibition assay (HIA) titers for at least one of the 3 vaccine strains included in the trivalent vaccine.;Timepoint(s) of evaluation of this end point: The primary outcome will be the seroconversion rate at day 28.

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Secondary

Measure	Time frame
Secondary end point(s): The main secondary outcomes will include the proportion of patients with clinical and subclinical influenza at day 180 and additional immunogenicity parameters (seroprotection rate and antibody titers).;Timepoint(s) of evaluation of this end point: The main secondary outcomes will include the proportion of patients with clinical and subclinical influenza at day 180 and additional immunogenicity parameters (seroprotection rate and antibody titers).	—

Measure

Time frame

Secondary end point(s): The main secondary outcomes will include the proportion of patients with clinical and subclinical influenza at day 180 and additional immunogenicity parameters (seroprotection rate and antibody titers).;Timepoint(s) of evaluation of this end point: The main secondary outcomes will include the proportion of patients with clinical and subclinical influenza at day 180 and additional immunogenicity parameters (seroprotection rate and antibody titers).

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Countries

Spain, Switzerland

Contacts

Public ContactUICEC - HUVR

Unidad de Investigación Clínica y Ensayos Clínicos del Hospital Universitario Virgen del Rocío

claram.rosso.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026