Clinical Trials Register

Summary
EudraCT Number:	2013-002080-26
Sponsor's Protocol Code Number:	V58P15
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-01
Trial results	View 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

2013-002080-26

A.3

Full title of the trial

A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (tivc) or in Embryonated Eggs (TIV), in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

Estudio de fase III, multicéntrico, aleatorizado con observador ciego para evaluar la seguridad de las vacunas antigripales trivalentes de subunidades producidas en cultivo de células de mamífero (VATc) o en huevos embrionados (VAT), en niños y adolescentes entre 3 y < 18 años de edad con riesgo de presentar complicaciones relacionadas con la gripe

A.3.1

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

Clinical study to compare the safety of two influenza vaccines in children and adolescents of 3 to less than 18 years of age at risk for influenza-related complications

Ensayo clínico para comparar la seguridad de dos vacunas antigripales en niños y adolescentes entre 3 y < 18 años de edad con riesgo de presentar complicaciones relacionadas con la gripe

A.4.1

Sponsor's protocol code number

V58P15

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/210/2012

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Vaccines & Diagnostics AG
B.1.3.4	Country	Switzerland
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	Novartis Vaccines and Diagnostics s.r.l
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Vaccines and Diagnostics S.L.
B.5.2	Functional name of contact point	Regional Clinical Research Associat
B.5.3	Address:
B.5.3.1	Street Address	Gran Via de les Corts Catalanes 764
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	E-08013
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034933064722
B.5.5	Fax number	0034933064572
B.5.6	E-mail	nuria.colillas@novartis.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	Optaflu
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Vaccines and Diagnostics GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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	A/ (H1N1)-LIKE VIRUS ANTIGEN
D.3.9.3	Other descriptive name	A/ (H1N1)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117552
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	A/ (H3N2)-LIKE VIRUS ANTIGEN
D.3.9.3	Other descriptive name	A/ (H3N2)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117553
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	B/ -LIKE VIRUS ANTIGEN
D.3.9.3	Other descriptive name	B/ -LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117554
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.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	Chiroflu
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Vaccines and Diagnostics S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	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	A/ (H1N1)-LIKE VIRUS ANTIGEN
D.3.9.3	Other descriptive name	A/ (H1N1)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117552
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
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	A/ (H3N2)-LIKE VIRUS ANTIGEN
D.3.9.3	Other descriptive name	A/ (H3N2)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117553
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	B/ -LIKE VIRUS ANTIGEN
D.3.9.3	Other descriptive name	B/ -LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117554
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

volunteers at high risk for influenza-related complications (protection against influenza)

voluntarios con riesgo de presentar complicaciones relacionadas con la gripe (protección contra la gripe)

E.1.1.1

Medical condition in easily understood language

volunteers at high risk for influenza-related complications (protection against flu (influenza))

voluntarios con riesgo de presentar complicaciones relacionadas con la gripe (protección contra la gripe)

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10016794
E.1.2	Term	Flu vaccination
E.1.2	System Organ Class	100000004865

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 evaluate the safety and tolerability of 1 or 2 intramuscular doses (administered 4 weeks apart) of either the cell culture-derived influenza vaccine TIVc or the egg-derived influenza vaccine TIV in children and adolescents 3 to <18 years of age at risk for influenza-related complications.

Evaluar la seguridad y la tolerabilidad de 1 o 2 dosis intramusculares (administradas con un intervalo de 4 semanas) de la vacuna antigripal obtenida a partir de cultivos celulares VATc o de la vacuna antigripal obtenida a partir de huevos VAT en niños y adolescentes entre 3 y <18 años de edad con riesgo de presentar complicaciones relacionadas con la gripe.

E.2.2

Secondary objectives of the trial

This study has no secondary objectives.

Este estudio no tiene objetivos secundarios.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males and females 3 through 17 years of age at the time of enrollment who are at high risk for influenza-related complications including subjects with confirmed documented medical history of any of the following criteria, as per the WHO recommendations (Weekly Epidemiological Record. 2005;33(80):279-87).
2. Individuals with parents/legal guardians who have given written consent after the nature of the study has been explained according to local regulatory requirements (and where applicable according to local regulations, informed assent for subjects above the specified age).
3. Subjects who, or subjects whose parent/legal guardian, are able to comply with all study procedures and requirements

1.Sujetos de ambos sexos entre 3 y 17 años de edad en el momento de inclusión que estén en alto riesgo de presentar complicaciones relacionadas con la gripe, incluidos los sujetos con historia clínica confirmada documentada de alguno de los siguientes criterios según las recomendaciones de la OMS (OMS 2005, Weekly Epidemiological Record. 2005;33(80):279-87
2 .Sujetos cuyos padres/tutores legales hayan dado consentimiento escrito después de que se les haya explicado la naturaleza del estudio según los requisitos normativos locales (y si procede según la normativa local, el asentimiento informado en el caso de sujetos mayores de la edad determinada).
3. Sujetos que sean capaces de cumplir con todos los procedimientos y requisitos del estudio o sujetos cuyos padres/tutor legal sean capaces de cumplir con los mismos.

E.4

Principal exclusion criteria

1. Individuals whose parent(s)/legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
2. Individuals with a history of Guillain-Barré syndrome.
3. Individuals with any fatal prognosis of an underlying medical condition (<12 month life expectancy).
4. Individuals hospitalized at the time of enrolment.
5. Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components.
6. Children of research staff involved with the clinical study at this institution or who are otherwise related to research staff or have household members who are research staff associated with the investigator.
7. Individuals with acute disease and/or fever (ie, body temperature measurement ?38°C [?100.4°F]) within 3 days prior to vaccination.
8. Individuals who have received vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment into this study.
9. Individuals who received another investigational agent within 30 days prior to enrollment or before completion of the safety follow-up period or who are unwilling to refuse to participate in another clinical study through the duration of this study.
10. Individuals who have been immunized with any influenza vaccine (licensed or investigational) within 6 months prior to enrolment or with planned influenza vaccination (other than study vaccine) during the study.
11. Individuals who have been given an antipyretic in the past 24 hours prior to vaccination.
12. Individuals with any other condition which, in the opinion of the investigator, prevents the subject?s participation in the study.
13. Individuals whose parent(s)/legal guardian(s) are unwilling to be contacted by the phone for the safety phone calls or active influenza surveillance.
14. Individuals who are pregnant or breastfeeding.
15. If 9-17 years of age and female, ?of childbearing potential?, sexually active, and has not used any of the ?acceptable contraceptive methods? for at least 2 months prior to study entry and refuses to use an acceptable contraceptive method through the end of the study.
16. Female subjects of childbearing potential with a positive or indeterminate pregnancy test.

1.Sujetos cuyos padres/tutores legales no puedan comprender ni seguir todos los procedimientos del estudio necesarios durante el periodo del estudio.
2. Sujetos con antecedentes de síndrome de Guillain-Barré.
3. Sujetos con pronóstico mortal de enfermedad subyacente (esperanza de vida <12 meses).
4. Sujetos hospitalizados en el momento de la inclusión.
5. Sujetos con antecedentes de cualquier anafilaxis, reacciones graves a vacunas o hipersensibilidad a alguno de los componentes de la vacuna.
6. Hijos/as del personal investigador que esté involucrado en el estudio clínico en este centro o niños que estén relacionados con el personal investigador o que tengan miembros familiares que formen parte del personal investigador relacionado con el investigador.
7. Sujetos con enfermedad aguda y/o fiebre (es decir, medición de la temperatura corporal ?38°C [?100,4°F]) durante los 3 días anteriores a la vacunación.
8. Sujetos que hayan recibido vacunas durante los 14 días (en el caso de vacunas inactivadas) o 28 días (en el caso de vacunas vivas) anteriores a su inclusión en este estudio.
9. Sujetos que hayan recibido otro fármaco en investigación durante los 30 días anteriores a la inclusión o antes de la finalización del periodo de seguimiento de seguridad o que tengan falta de voluntad para negarse a participar en otro estudio clínico durante el periodo de este estudio.
10. Sujetos que hayan sido inmunizados con alguna vacuna antigripal (comercializada o en investigación) durante los 6 meses anteriores a la inclusión o que tengan prevista una vacunación antigripal (salvo la vacuna del estudio) durante el estudio.
11. Sujetos que hayan recibido un antipirético durante las 24 horas anteriores a la vacunación.
12. Sujetos con cualquier otra condición que, según el criterio del investigador, impida la participación del sujeto en el estudio.
13. Sujetos cuyos padres/tutores legales no deseen ser contactados por teléfono en las llamadas telefónicas de seguridad o en la vigilancia activa de la gripe.
14. Sujetos que estén embarazadas o en periodo de lactancia.
15. Sujetos (mujeres) entre 9 y 17 años de edad, en edad fértil, sexualmente activas que no hayan utilizado ningún "método anticonceptivo aceptable" durante al menos 2 meses antes de entrar en el estudio y que se nieguen a utilizar un método anticonceptivo aceptable hasta el final del estudio.
16. Sujetos (mujeres) en edad fértil que con un resultado positivo o indeterminado en la prueba de embarazo.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint for this study is safety: proportion of subjects reporting solicited AEs (including local and systemic and other solicited AEs); proportion of subjects reporting unsolicited AEs; proportion of subjects reporting SAEs, new onset of chronic diseases, medically attended AEs, and AEs leading to vaccine/study withdrawal

La variable principal de este estudio es la seguridad: proporción de sujetos que notifiquen AA solicitados (incluidos los AA locales y sistémicos y otros AA solicitados); proporción de sujetos que notifiquen AA no solicitados; proporción de sujetos que notifiquen AAG, ECNA, AA que hayan requerido asistencia médica y AA que causen la retirada de la vacuna/estudio

E.5.1.1

Timepoint(s) of evaluation of this end point

- Solicited adverse events: day of vaccination and the following 6 days (day 1 to day 7 and day 29 to day 35?the latter only for not previously vaccinated subjects);
- Unsolicited adverse events: AEs occurring for approximately 3 to 4 weeks after each vaccination (ie, from day 1 to day 28; and from day 29 to day 49?the latter only for not previously vaccinated subjects);
- SAEs, new onset of chronic diseases, medically attended AEs, and AEs leading to vaccine/study withdrawal: up to day 213 for ?not previously vaccinated? subjects 3 to <9 years or up to day 183 for all other subjects.

- AA solicitados: el día de la vacunación y durante los 6 días siguientes (del día 1 al día 7 y del día 29 al día 35; este último solo para sujetos no previamente vacunados).
- AA no solicitados: AA que ocurran aproximadamente 3 o 4 semanas después de cada vacunación (es decir, del día 1 al día 1 al día 28; y del día 29 al día 49; este último solo para sujetos no previamente vacunados).
- AAG, ECNA, AA que hayan requerido asistencia médica y AA que causen la retirada de la vacuna/estudio: hasta el día 213 en los sujetos ?no previamente vacunados? entre 3 y <9 años de edad o hasta el día 183 en el resto de sujetos.

E.5.2

Secondary end point(s)

There are no secondary endpoints in this study

En este estudio no se consideran otras variables.

E.5.2.1

Timepoint(s) of evaluation of this end point

There are no secondary endpoints in this study

En este estudio no se consideran otras variables.

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

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Observador ciego

Observer blind

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

UVUS

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

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:

504

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:

280

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

224

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

F.3.2

Patients

Yes

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

Yes

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

Patients with neurological and neurodevelopmental conditions and in particular intellectual disability (mental retardation) and moderate to severe developmental delay.
Patients under age.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

300

F.4.2

For a multinational trial

F.4.2.1

In the EEA

504

F.4.2.2

In the whole clinical trial

504

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)

If the subject agrees to submit this information, the pregnancy must be followed to determine outcome. This follow-up should occur even if the intended duration of safety follow-up for the study has ended. Any AE that occurs outside of the protocol-specified observation period or after the end of the study, but considered to be caused by the study vaccine, must be reported to NVD.

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

2013-09-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-08-05

P. End of Trial
P.	End of Trial Status	Completed

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