Clinical Trials Register

Summary
EudraCT Number:	2022-000576-19
Sponsor's Protocol Code Number:	VAP00026
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2022-06-09
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2022-000576-19

A.3

Full title of the trial

Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared with Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.

Inmunogenicidad y seguridad de la vacuna antigripal tetravalente recombinante en comparación con la vacuna antigripal tetravalente de dosis estándar a base de huevo en niños de 3 a 8 años.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study with Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared with Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

Estudio con la vacuna antigripal tetravalente recombinante (RIV4) en comparación con la vacuna antigripal tetravalente a base de huevo (IIV4) en participantes de 3 a 8 años.

A.4.1

Sponsor's protocol code number

VAP00026

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1256-8841

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/100/2022

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sanofi Pasteur Inc
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sanofi Pasteur Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanofi-Aventis, S.A.
B.5.2	Functional name of contact point	Unidad de Estudios Clínicos
B.5.3	Address:
B.5.3.1	Street Address	c/ Josep Pla 2, 4ª Planta
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08019
B.5.3.4	Country	Spain
B.5.4	Telephone number	34934859400
B.5.6	E-mail	es-unidadestudiosclinicos@sanofi.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Supemtek
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Supemtek
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	rHA protein, derived from Influenza A virus subtype H1N1
D.3.9.3	Other descriptive name	Influenza A virus subtype H1N1 haemagglutinin, recombinant
D.3.9.4	EV Substance Code	SUB201781
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	rHA protein, derived from Influenza A virus subtype H3N2
D.3.9.3	Other descriptive name	Influenza A virus subtype H3N2 haemagglutinin, recombinant
D.3.9.4	EV Substance Code	SUB201783
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	rHA protein, derived from Influenza B virus Victoria lineage
D.3.9.3	Other descriptive name	Influenza B virus Victoria lineage haemagglutinin, recombinant
D.3.9.4	EV Substance Code	SUB201782
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	rHA protein, derived from Influenza B virus Yamagata lineage
D.3.9.3	Other descriptive name	Influenza B virus Yamagata lineage haemagglutinin, recombinant
D.3.9.4	EV Substance Code	SUB201784
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Fluarix Tetra
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fluarix Tetra
D.3.4	Pharmaceutical form	Suspension for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	A/ H1N1 strain
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	A/ H3N2 strain
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	B/ Victoria lineage strain
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	B/Yamagata lineage strain
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

E.1.1.1

Medical condition in easily understood language

Influenza

Gripe

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10059429
E.1.2	Term	Influenza immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate the non-inferior (NI) HAI immune response of RIV4 vs licensed IIV4 for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years

Demostrar la no inferioridad (NI) de la respuesta inmunitaria, medida por IHA, de la vacuna RIV4 con respecto a la vacuna IIV4 autorizada para las 4 cepas con base en el antígeno derivado de huevo en todos los participantes de 3 a 8 años. 

E.2.2

Secondary objectives of the trial

• To summarize the HAI immune response induced by RIV4 and IIV4 for the 4 strains based on the egg-derived antigen in participants aged 3 to 8 years
• To assess the safety profile of each vaccine in all participants and by age group

• Resumir la respuesta inmunitaria medida por IHA inducida por las vacunas RIV4 e IIV4 para las 4 cepas con base en el antígeno derivado de huevo en participantes de 3 a 8 años. 

• Evaluar el perfil de seguridad de cada vacuna en todos los participantes y por grupo de edad.  

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Aged 3 to 8 years on the day of inclusion
- Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations

- Edad de 3 a 8 años al día de la inclusión. 
- El participante firmó y fechó el formulario de asentimiento (de conformidad con las reglamentaciones locales) y el padre/la madre u otro representante legal y un testigo independiente firmaron y fecharon el formulario de consentimiento informado, si así lo requieren las reglamentaciones locales. 

E.4

Principal exclusion criteria

Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Thrombocytopenia
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
- Personal or family history of Guillain-Barré Syndrome (GBS)
- Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Se excluirá del estudio a los participantes que cumplan alguno de los siguientes criterios:
-Inmunodeficiencia congénita o adquirida, conocida o sospechada, o recepción de terapias inmunosupresoras, como quimioterapia o radioterapia anticancerosa, en los últimos 6 meses, o terapia con corticoides sistémicos de largo plazo (prednisona o equivalente durante más de 2 semanas consecutivas en los 3 meses anteriores). 
- Hipersensibilidad sistémica conocida a cualquiera de los componentes de la vacuna o antecedentes de reacciones que pongan en peligro la vida por administración de las vacunas utilizadas en el ensayo, o a una vacuna que contenga cualquiera de las mismas sustancias. 
- Trombocitopenia.
- Trastornos hemorrágicos o administración de anticoagulantes en las 3 semanas anteriores a la inclusión, por lo cual quede contraindicada una vacunación intramuscular según el criterio del investigador.
- Antecedentes personales o familiares de síndrome de Guillain-Barré (GBS).
- Antecedentes personales de retraso clínicamente significativo del desarrollo (a juicio del investigador), de trastorno neurológico o de trastorno convulsivo.
NOTA: no está previsto que la información anterior contenga todos los aspectos relevantes para la posible participación de un paciente en un estudio clínico.

E.5 End points

E.5.1

Primary end point(s)

1- Individual Hemagglutination inhibition (HAI) titer at D29 after vaccination: Antibody titers are expressed as GMTs
2- Percentage of participants achieving seroconversion: Seroconversion for participants with a pre-vaccination titer lower than (<) 10 [1/dil] at D01 and a post-vaccination titer ≥ 40 [1/dil] at D29 or D57, or a pre-vaccination titer ≥ 10 [1/dil] at D1 and a ≥ 4-fold increase in post-vaccination titer at D29 or D57

1- Título individual de inhibición de la hemaglutinación (IHA) el D29 después de la vacunación: los títulos de anticuerpos se expresan como GMT 
2- Porcentaje de participantes que alcanzaron la seroconversión: seroconversión en los participantes con un título previo a la vacunación (<)10 [1/dil] en el D01 y un título posterior a la vacunación ≥40 [1/dil] en el D29 o el D57, o un título previo a la vacunación ≥10 [1/dil] en el D1 y un aumento de ≥4 veces en el título posterior a la vacunación el D29 o el D57.  

E.5.1.1

Timepoint(s) of evaluation of this end point

1 and 2: Day 29 or Day 57

1 y 2: día 29 o día 57

E.5.2

Secondary end point(s)

1- Individual Hemagglutination inhibition (HAI) titer at Day01 and at D29 after vaccination
2- Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil]
3- Percentage of participants with antibody titers greater than or equal to (≥) 40 [1/dil]
4- Occurrence of immediate adverse events (AEs): Immediate adverse events include unsolicited systemic adverse events within 30 minutes after vaccination
5- Occurrence of solicited injection site reactions and systemic reactions: Adverse reactions pre-listed in the (electronic) case report book (CRB)
Injection site reactions: pain, redness, swelling, hardening, bruising
Systemic reactions: fever, headache, malaise, myalgia
6- Occurrence of unsolicited AEs: AEs that other than solicited reactions
7- Occurrence of attended adverse event (MAAEs)
8- Occurrence of serious adverse events (SAEs): SAEs, including adverse event of special interest (AESIs)

1- Título individual de inhibición de la hemaglutinación (IHA) en el día 01 y el día 29 después de la vacunación. 
2- Porcentaje de participantes con títulos de anticuerpos detectables iguales o mayores a (≥) 10 [1/dil].
3- Porcentaje de participantes con títulos de anticuerpos iguales o mayores a (≥)40 [1/dil]. 
4- Ocurrencia de acontecimientos adversos (AA) inmediatos: los acontecimientos adversos inmediatos incluyen acontecimientos adversos sistémicos no solicitados en los 30 minutos posteriores a la vacunación. 
5- Ocurrencia de reacciones solicitadas en el lugar de la inyección y de reacciones sistémicas: reacciones adversas enumeradas previamente en el cuaderno (electrónico) de recogida de datos (CRB). Reacciones en el lugar de la inyección: dolor, enrojecimiento, hinchazón, endurecimiento y moretones. Reacciones sistémicas: fiebre, dolor de cabeza, malestar general y mialgia.
6- Ocurrencia de AA no solicitados: AA distintos a las reacciones solicitadas.
7- Ocurrencia del acontecimiento adverso tratado (AAm).
8- Ocurrencia de acontecimientos adversos graves (AAG): AAG, incluidos los acontecimientos adversos de interés especial (AAIE).

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 2 and 3: Day 1 and Day 29 or Day 57
4: Within 30 minutes after each vaccination
5: Within 8 days after each vaccination
6 and 7: Up to 28 days after each vaccination
8: From Day 1 until the EoS (up to 6 months after vaccination)

1, 2 y 3: día 1 y día 29 o día 57
4: en los 30 minutos siguientes a cada vacunación.
5: en los 8 días siguientes a cada vacunación. 
6 y 7: hasta 28 días después de cada vacunación.
8: desde el día 1 hasta la finalización del estudio (hasta 6 meses después de la vacunación).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

immunogenicity

Inmunogenicidad

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

United States

Poland

Bulgaria

Spain

Czechia

Denmark

E.8.7

Trial has a data monitoring committee

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

LVLS

Última visita del último sujeto

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

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 months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

1412

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

1412

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children (3 to 8 years old)

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

242

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1059

F.4.2.2

In the whole clinical trial

1412

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-07-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-07-27

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-12-07

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