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STOP-FLU Influenza Prevention Organ Transplant Phase 3 Trial

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Summary

The EU Clinical Trials Register has published registration details for EudraCT 2019-001974-27, the Phase 3 STOP-FLU trial titled 'Reducing the Burden of Influenza after Solid-Organ Transplantation.' The non-commercial trial is sponsored by Centre Hospitalier Universitaire Vaudois (CHUV) in Switzerland with funding from the Swiss National Science Foundation, and is being conducted at sites in Spain under AEMPS oversight. The trial compares adjuvanted influenza vaccine Fluad (test IMP) against standard inactivated vaccine VaxigripTetra (comparator) in solid organ transplant recipients, with a focus on assessing immunological response in immunocompromised patients.

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

— EMA , verbatim from source
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The EU Clinical Trials Register published a Phase 3 clinical trial registration for the STOP-FLU trial (EudraCT 2019-001974-27), an EEA CTA under Spain's AEMPS oversight, testing adjuvanted influenza vaccine Fluad against comparator VaxigripTetra in immunocompromised solid organ transplant recipients.

Healthcare providers, clinical investigators, and transplant programs should note this trial registration as it reflects ongoing research into improved influenza vaccination strategies for immunocompromised populations. Pharmaceutical companies and clinical research organizations involved in vaccine development or transplant medicine may also find this relevant for pipeline and trial landscape awareness.

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Apr 23, 2026

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| Summary | |
| --- | |
| EudraCT Number: | 2019-001974-27 |
| Sponsor's Protocol Code Number: | STOPFLU |
| National Competent Authority: | Spain - AEMPS |
| Clinical Trial Type: | EEA CTA |
| Trial Status: | Ongoing |
| Date on which this record was first entered in the EudraCT database: | 2019-08-09 |
| Trial results | |

Index
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Expand All Collapse All
| A. Protocol Information
A.1
A.2
A.3
[Swiss Trial in solid Organ transplantation on Prevention of inFLUenza]
Reducción de la carga de enfermedad por gripe tras un trasplante de órganos sólidos: ensayo clínico STOP-FLU [Swiss Trial in solid Organ transplantation on Prevention of inFLUenza]
[Swiss Trial in solid Organ transplantation on Prevention of inFLUenza]
Reducing the Burden of Influenza after Solid-Organ Transplantation: the STOP-FLU trial
[Swiss Trial in solid Organ transplantation on Prevention of inFLUenza]
Reducción de la carga de enfermedad por gripe tras un trasplante de órganos sólidos: ensayo clínico STOP-FLU [Swiss Trial in solid Organ transplantation on Prevention of inFLUenza]
A.3.1
Reducción de la carga de enfermedad por gripe tras un trasplante de órganos sólidos: ensayo clínico STOP-FLU
Reducing the Burden of Influenza after Solid-Organ Transplantation: the STOP-FLU trial
Reducción de la carga de enfermedad por gripe tras un trasplante de órganos sólidos: ensayo clínico STOP-FLU
A.3.2
STOP-FLU
A.4.1
A.7
A.8

| B. Sponsor Information
B.Sponsor: 1
B.1.1
B.1.3.4
B.3.1 and B.3.2
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1
B.4.2
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1
B.5.2
B.5.3
B.5.3.1
B.5.3.2
B.5.3.3
B.5.3.4
B.5.4
B.5.5
B.5.6

| D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3
D.2
D.2.1
D.2.1.1.1
D.2.1.1.2
D.2.1.2
D.2.5
D.2.5.1
D.3 Description of the IMP
D.3.4
D.3.4.1
D.3.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8
D.3.9.3
D.3.9.4
D.3.10
D.3.10.1
D.3.10.2
D.3.10.3
D.3.8
D.3.9.3
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.8
D.3.9.3
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.8
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.11 The IMP contains an:
D.3.11.1
D.3.11.2
D.3.11.3
D.3.11.3.1
D.3.11.3.2
D.3.11.3.3
D.3.11.3.4
D.3.11.3.5
D.3.11.4
D.3.11.5
D.3.11.6
D.3.11.7
D.3.11.8
D.3.11.9
D.3.11.10
D.3.11.11
D.3.11.12
D.3.11.13
D.IMP: 2
D.1.2 and D.1.3
D.2.1.1.1
D.2.1.1.2
D.2.5.1
D.3 Description of the IMP
D.3.4.1
D.3.8
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.8
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.8
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.11 The IMP contains an:
D.3.11.3
D.3.11.3.2
D.3.11.3.3
D.3.11.8
D.3.11.9
D.3.11.11
D.3.11.12
D.IMP: 3
D.1.2 and D.1.3
D.2.1.1.1
D.2.1.1.2
D.2.1.2
D.2.5.1
D.3 Description of the IMP
D.3.4
D.3.4.1
D.3.8
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.8
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.8
D.3.9.4
D.3.10
D.3.10.2
D.3.10.3
D.3.11 The IMP contains an:
D.3.11.3
D.3.11.3.2
D.3.11.3.3
D.3.11.8
D.3.11.9
D.3.11.11
D.3.11.12

| D.8 Information on Placebo

| E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1
Gripe en pacientes con trasplante de órgano sólido
Influenza in solid organ transplant patients
Gripe en pacientes con trasplante de órgano sólido
E.1.1.1
Influenza in solid organ transplant patients
E.1.1.2
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.2
E.1.3
E.2 Objective of the trial
E.2.1

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. |
| Comparar la inmunogenicidad de dos nuevas estrategias de vacunación, que consisten en la vacunación con una vacuna antigripal de alta dosis o una vacuna antigripal adjuvaya con MF59, con la vacunación de dosis estándar (tratamiento estándar) en una población de receptores de trasplante de órgano sólido. | | 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. | Comparar la inmunogenicidad de dos nuevas estrategias de vacunación, que consisten en la vacunación con una vacuna antigripal de alta dosis o una vacuna antigripal adjuvaya con MF59, con la vacunación de dosis estándar (tratamiento estándar) en una población de receptores de trasplante de órgano sólido. |
| 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. |
| Comparar la inmunogenicidad de dos nuevas estrategias de vacunación, que consisten en la vacunación con una vacuna antigripal de alta dosis o una vacuna antigripal adjuvaya con MF59, con la vacunación de dosis estándar (tratamiento estándar) en una población de receptores de trasplante de órgano sólido. |
| E.2.2 | Secondary objectives of the trial | | 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. |
| Evaluar la eficacia de las nuevas estrategias de vacunación para reducir la incidencia de gripe, correlacionar las respuestas humorales a la vacunación con la protección contra la gripe y evaluar la influencia de la inmunosupresión en las respuestas de la vacuna antigripal. | | 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. | Evaluar la eficacia de las nuevas estrategias de vacunación para reducir la incidencia de gripe, correlacionar las respuestas humorales a la vacunación con la protección contra la gripe y evaluar la influencia de la inmunosupresión en las respuestas de la vacuna antigripal. |
| 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. |
| Evaluar la eficacia de las nuevas estrategias de vacunación para reducir la incidencia de gripe, correlacionar las respuestas humorales a la vacunación con la protección contra la gripe y evaluar la influencia de la inmunosupresión en las respuestas de la vacuna antigripal. |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
| Se incluirán los receptores estables de trasplante de órgano sólido de ≥ 18 años y ≥3 meses después del trasplante, seguidos regularmente en sus respectivas clínicas ambulatorias en los 7 centros de trasplante y seleccionados para recibir la vacuna anual contra la gripe. | | 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. | Se incluirán los receptores estables de trasplante de órgano sólido de ≥ 18 años y ≥3 meses después del trasplante, seguidos regularmente en sus respectivas clínicas ambulatorias en los 7 centros de trasplante y seleccionados para recibir la vacuna anual contra la gripe. |
| 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. |
| Se incluirán los receptores estables de trasplante de órgano sólido de ≥ 18 años y ≥3 meses después del trasplante, seguidos regularmente en sus respectivas clínicas ambulatorias en los 7 centros de trasplante y seleccionados para recibir la vacuna anual contra la gripe. |
| E.4 | Principal 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. |
| Los candidatos se excluirán en caso de reacción grave previa o alergia a una de las vacunas del estudio o en caso de tratamiento por rechazo agudo, entre otros. | | 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. | Los candidatos se excluirán en caso de reacción grave previa o alergia a una de las vacunas del estudio o en caso de tratamiento por rechazo agudo, entre otros. |
| 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. |
| Los candidatos se excluirán en caso de reacción grave previa o alergia a una de las vacunas del estudio o en caso de tratamiento por rechazo agudo, entre otros. |
| E.5 End points |
| E.5.1 | 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. |
| Tasa de seroconversión al día 28. | | 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. | Tasa de seroconversión al día 28. |
| 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. |
| Tasa de seroconversión al día 28. |
| E.5.1.1 | Timepoint(s) of evaluation of this end point | | The primary outcome will be the seroconversion rate at day 28. |
| Tasa de seroconversión al día 28. | | The primary outcome will be the seroconversion rate at day 28. | Tasa de seroconversión al día 28. |
| The primary outcome will be the seroconversion rate at day 28. |
| Tasa de seroconversión al día 28. |
| E.5.2 | 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). |
| Los principales resultados secundarios incluirán la proporción de pacientes con gripe clínica y subclínica en el día 180 y parámetros de inmunogenicidad adicionales (tasa de seroprotección y títulos de anticuerpos). | | 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). | Los principales resultados secundarios incluirán la proporción de pacientes con gripe clínica y subclínica en el día 180 y parámetros de inmunogenicidad adicionales (tasa de seroprotección y títulos de anticuerpos). |
| 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). |
| Los principales resultados secundarios incluirán la proporción de pacientes con gripe clínica y subclínica en el día 180 y parámetros de inmunogenicidad adicionales (tasa de seroprotección y títulos de anticuerpos). |
| E.5.2.1 | 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). |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 | The trial involves single site in the Member State concerned | Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | | Switzerland | | Switzerland |
| Switzerland |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 | Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial | | Planned Last Patient Last Visit: June 2020 |
| Último Paciente Última Visita: Junio 2020 | | Planned Last Patient Last Visit: June 2020 | Último Paciente Última Visita: Junio 2020 |
| Planned Last Patient Last Visit: June 2020 |
| Último Paciente Última Visita: Junio 2020 |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months |
| E.8.9.1 | In the Member State concerned days |
| E.8.9.2 | In all countries concerned by the trial years | 2 |

| F. Population of Trial Subjects
F.1 Age Range
F.1.1
F.1.1.1
F.1.1.2
F.1.1.3
F.1.1.4
F.1.1.5
F.1.1.6
F.1.2
F.1.2.1
F.1.3
F.1.3.1
F.2 Gender
F.2.1
F.2.2
F.3 Group of trial subjects
F.3.1
F.3.2
F.3.3
F.3.3.1
F.3.3.2
F.3.3.3
F.3.3.4
F.3.3.5
F.3.3.6
F.3.3.7
F.4 Planned number of subjects to be included
F.4.1
F.4.2
F.4.2.1
F.4.2.2
F.5
(if it is different from the expected normal treatment of that condition)
Ninguno
None
Ninguno

| G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1
G.4.3.4
G.4 Investigator Network to be involved in the Trial: 2
G.4.1
G.4.3.4

| N. Review by the Competent Authority or Ethics Committee in the country concerned
N.
N.
N.
N.
N.

| P. End of Trial
P.

Mentioned entities

European Medicines Agency

Parties

Centre Hospitalier Universitaire Vaudois

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Classification

Agency
EMA
Published
August 9th, 2019
Instrument
Notice
Branch
International
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Pharmaceutical companies Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Vaccination Clinical trial registration Immunological medicinal product
Geographic scope
European Union EU

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Public Health

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