Clinical Trials Register

Summary
EudraCT Number:	2019-000201-69
Sponsor's Protocol Code Number:	D5290C00005
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:	2019-09-04
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

2019-000201-69

A.3

Full title of the trial

A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

Estudio en fase II/III aleatorizado, doble ciego, controlado con palivizumab para evaluar la seguridad de MEDI8897, un anticuerpo monoclonal con una semivida prolongada frente al virus respiratorio sincitial, en niños de alto riesgo (MEDLEY)

A.3.1

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

Clinical Study to Evaluate the Safety of MEDI8897, an Experimental Drug, for Preventing Serious Respiratory Syncytial Virus Disease in High-risk Children.

Estudio clínico para evaluar la seguridad de MEDI8897, un fármaco experimental, para prevenir la enfermedad grave por virus respiratorio sincitial en niños de alto riesgo.

A.3.2

Name or abbreviated title of the trial where available

MEDLEY

A.4.1

Sponsor's protocol code number

D5290C00005

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/141/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MedImmune, LLC
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	MedImmune, LLC
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	MedImmune, LLC
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	One MedImmune Way
B.5.3.2	Town/ city	Gaithersburg, MD
B.5.3.3	Post code	20878
B.5.3.4	Country	United States
B.5.6	E-mail	information.center@astrazeneca.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	No
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.3.2	Product code	MEDI8897
D.3.4	Pharmaceutical form	Solution for injection
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	nirsevimab
D.3.9.1	CAS number	1989556-22-0
D.3.9.2	Current sponsor code	MEDI8897
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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)	No
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	Synagis
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Deutschland GmbH Co. KG
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	Synagis
D.3.2	Product code	Palivizumab
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
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)	No
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The prevention of medically attended RSV LRTI.

Prevención de infecciones de las vías respiratorias inferiores por VRS.

E.1.1.1

Medical condition in easily understood language

To prevent serious lower respiratory tract infection caused by RSV.

Prevención de infecciones graves de las vías respiratorias inferiores causadas por VRS.

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	LLT
E.1.2	Classification code	10066742
E.1.2	Term	Respiratory syncytial virus infection prophylaxis
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 MEDI8897 compared to palivizumab when administered to high-risk infants eligible to receive palivizumab entering their first RSV season and children with chronic lung disease (CLD) or congenital heart disease (CHD) entering their first and second RSV season.

Evaluar la seguridad y la tolerabilidad de MEDI8897 comparado con palivizumab cuando se administra a bebés prematuros que inician su primera temporada del VRS y niños con EPC o CPC que inician su primera y segunda temporada del VRS

E.2.2

Secondary objectives of the trial

1. To evaluate serum concentrations of MEDI8897 and palivizumab
2. To evaluate ADA responses to MEDI8897 and to palivizumab in serum
3. To assess the descriptive efficacy of MEDI8897 when administered as a single IM dose in the first RSV season or a single IM dose administered in the second RSV season, in reducing medically attended LRTI (inpatient and outpatient) and hospitalization due to RT-PCR-confirmed RSV, compared to palivizumab

1. Evaluar las concentraciones séricas de MEDI8897 y de palivizumab
2. Evaluar las respuestas por AAF frente a MEDI8897 y palivizumab en suero
3. Evaluar la eficacia descriptiva de MEDI8897, cuando se administra como una única dosis en la primera temporada del VRS o de una única administrada en la segunda temporada del VRS, en la reducción de las IVRI atendidas médicamente (asistencia intrahospitalaria y ambulatoria) y de la hospitalización debidas a VRS confirmado con RT-PCR, en comparación con palivizumab.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following criteria:
1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born ≤ 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:
(a) Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
(b) Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
2. For the CLD/CHD cohort:
(a) Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
(b) Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
3. Infants who are entering their first RSV season at the time of screening
4. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
5. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator
6. Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD

Los sujetos deben cumplir con todos los siguientes criterios:
1. Para la cohorte de prematuros (excluyendo los sujetos con EPC o CPC hemodinámicamente significativos): recién nacidos prematuros en su primer año de vida y nacidos ≤ 35 semanas 0 días GA elegible para recibir palivizumab de acuerdo con las pautas nacionales o locales, incluidas aquellas con:
(a) Defectos pequeños septales auriculares o ventriculares no complicados o conducto arterioso persistente, o
(b) Estenosis aórtica, estenosis pulmonar o solo coartación de la aorta
2. Para la cohorte EPC / CPC:
(a) Sujetos con EPC: bebés en su primer año de vida y un diagnóstico de EPC de prematuridad que requiere intervención / manejo médico (es decir, oxígeno complementario, broncodilatadores o diuréticos) dentro de los 6 meses anteriores a la asignación al azar
(b) Sujetos con cardiopatía coronaria: lactantes en su primer año de vida y cardiopatía hemodinámicamente significativa documentada (debe ser no operada o parcialmente corregida). Nota: los lactantes con lesiones cardiacas acianóticas hemodinámicamente significativas deben tener hipertensión pulmonar (≥40 mmHg, presión medida en el arteria pulmonar) o la necesidad de medicación diaria para controlar la CPC
3. Los bebés que están ingresando a su primera temporada de VRS en el momento de la evaluación
4. Consentimiento informado por escrito y cualquier autorización requerida localmente (p. Ej., La Ley de Responsabilidad y Portabilidad del Seguro de Salud en los EE. UU., Directiva de Privacidad de Datos de la UE en la UE) obtenida de los padres / representantes legales del sujeto antes de realizar cualquier protocolo procedimientos relacionados, incluidas las evaluaciones de detección
5. El (los) padre (s) / representante (s) legal (es) del sujeto son capaces de entender y cumplir con los requisitos del protocolo, incluidas las visitas de seguimiento y enfermedad según lo juzgue el investigador
6. El sujeto está disponible para completar el período de seguimiento, que será 1 año después de la Temporada 1 / Dosis 1 para sujetos sin EPC / CPC, o 1 año después de la Temporada 2 / Dosis 1 (o la última dosis de reemplazo según corresponda para CPC) para sujetos con EPC / CPC

E.4

Principal exclusion criteria

Any of the following would exclude the subject from participation in the study:
1. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
2. Any history of LRTI or active LRTI prior to, or at the time of, randomization
3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
6. Anticipated cardiac surgery within 2 weeks after randomization
7. Anticipated survival of < 6 months after randomization
8. Receipt of any investigational drug
9. Known renal impairment
10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
11. Clinically significant congenital anomaly of the respiratory tract
12. Chronic seizure, or evolving or unstable neurologic disorder
13. Prior history of a suspected or actual acute life-threatening event
14. Known immunodeficiency, including human immunodeficiency virus (HIV)
15. Mother with HIV infection (unless the child has been proven to be not infected)
16. Any known allergy, including to immunoglobulin products, or history of allergic reaction
17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
20. Concurrent enrollment in another interventional study
21. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Cualquiera de los siguientes excluiría al sujeto de la participación en el estudio:
1. Cualquier fiebre (≥ 100.4 ° F [≥ 38.0 ° C], independientemente de la ruta) o enfermedad aguda dentro de los 7 días anteriores a la aleatorización
2. Cualquier historia de infección de vías respiratorias inferiores o infección de vías respiratorias inferiores activa antes de, o en el momento de la aleatorización
3. Antecedentes conocidos de infección por VRS o infección activa por VRS antes de, o en el momento de la aleatorización
4. Hospitalización en el momento de la asignación al azar, a menos que se espere el alta dentro de los 7 días posteriores a la asignación al azar
5. Requisitos para ventilación mecánica, oxigenación por membrana extracorpórea, presión positiva continua en las vías aéreas u otro soporte respiratorio o cardíaco mecánico en el momento de la aleatorización
6. Cirugía cardíaca anticipada dentro de las 2 semanas posteriores a la aleatorización
7. Supervivencia anticipada de <6 meses después de la aleatorización
8. Recepción de cualquier droga en investigación.
9. Insuficiencia renal conocida.
10. Disfunción hepática conocida, incluida una infección por hepatitis crónica o activa o presunta, conocida o sospechada
11. Anomalía congénita clínicamente significativa del tracto respiratorio.
12. Ataque crónico, o desorden neurológico inestable o en evolución.
13. Antecedentes previos de un evento grave o sospechoso de amenaza para la vida real
14. Inmunodeficiencia conocida, incluido el virus de inmunodeficiencia humana (VIH)
15. Madre con infección por VIH (a menos que se haya comprobado que el niño no está infectado)
16. Cualquier alergia conocida, incluso a productos de inmunoglobulina, o historial de reacción alérgica
17. Recepción de palivizumab u otro mAb de VRS o cualquier vacuna de VRS, incluida la vacuna materna de VRS
18. Recibo de cualquier anticuerpo monoclonal o policlonal (por ejemplo, inmunoglobulina intravenosa, inmunoglobulina intravenosa) o uso anticipado durante el estudio.
19. Cualquier condición que, en opinión del investigador, interfiera con la evaluación del fármaco del estudio o la interpretación de la seguridad de los sujetos o los resultados del mismo.
20. Matrícula concurrente en otro estudio intervencionista.
21. Los hijos de los empleados del patrocinador, el sitio del estudio clínico o cualquier otra persona involucrada en la realización del estudio, o los familiares inmediatos de dichas personas

E.5 End points

E.5.1

Primary end point(s)

Safety and tolerability of MEDI8897 as assessed by the occurrence of all treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), adverse events of special interest (AESIs), and new onset chronic diseases (NOCDs).

La seguridad y la tolerabilidad de MEDI8897 según la evaluación de la aparición de todos los eventos adversos emergentes consecuencia del tratamiento (EAECT), los eventos adversos graves emergentes consecuencia del tratamiento (EAGECT), los eventos adversos de interés especial (EAIE) y las enfermedades crónicas de inicio reciente (ECIR).

E.5.1.1

Timepoint(s) of evaluation of this end point

Occurrence of all TEAEs, TESAEs, AESIs, and NOCDs, will be assessed through the follow-up period (Day 361).

La ocurrencia de todos los EAECT, EAGECT, EAIE y ECIR se evaluará durante el período de seguimiento (día 361).

E.5.2

Secondary end point(s)

1. a. MEDI8897 and palivizumab serum concentrations
b. MEDI8897 and palivizumab PK parameters: Summary of serum concentrations and estimated PK parameters (Cmax, AUC, apparent clearance, and t1/2, if data permit)
2. Incidence of ADA to MEDI8897 and palivizumab in serum
3. a. Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2
b. Incidence of hospitalizations due to RT-PCR-confirmed RSV through 150 days after Dose 1 for Season 1 and Season 2

1. a. Concentraciones séricas de MEDI8897 y palivizumab.
b. Parámetros PK de MEDI8897 y palivizumab: resumen de las concentraciones séricas y parámetros estimados de PK (Cmax, AUC, eliminación aparente y t1 / 2, si los datos lo permiten)
2. Incidencia de ADA a MEDI8897 y palivizumab en suero
3. a. Incidencia de infecciones de vías respiratorias inferiores con asistencia médica (paciente hospitalizado y ambulatorio) debido a VRS confirmado por RT-PCR hasta 150 días después de la dosis 1 para la temporada 1 y la temporada 2
b. Incidencia de hospitalizaciones debido a VRS confirmado por RT-PCR hasta 150 días después de la dosis 1 para la temporada 1 y la temporada 2

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Blood will be collected to evaluate the PK of MEDI8897 and palivizumab in serum at screening and on Day 15, Day 151, Day 361 and as needed (PK samples will be collected for subjects hospitalised with LRTI) for season 1 and season 2 (CLD/CHD Cohort Only). Subjects requiring a replacement dose of study drug due to cardiac surgery with cardiopulmonary bypass will have a blood sample collected before and after surgery (prior to administering replacement dose) for PK evaluation.
2. ADA will be measured at screening and on Day 151 and Day 361 and as needed (ADA samples will be collected for subjects hospitalised with LRTI).
3. Incidence of LRTI and hospitalizations due to RSV will be monitored through Day 151 post dose in Season 1 and Season 2.

1. Se recogerá sangre para evaluar la PK de MEDI8897 y palivizumab en suero en la selección y en el Día 15, Día 151, Día 361 y según sea necesario para la temporada 1 y la temporada 2 ( Sólo cohorte EPC / CPC). A los sujetos que requieren una dosis de reemplazo del fármaco del estudio debido a una cirugía cardíaca con bypass cardiopulmonar se les tomará una muestra de sangre antes y después de la cirugía (antes de administrar la dosis de reemplazo) para la evaluación de la PK.
2. La ADA se medirá en la selección y en el Día 151 y el Día 361 y según sea necesario.
3. La incidencia de infecciones respiratorias inferiores y las hospitalizaciones debidas a VRS se controlarán hasta el Día 151 después de la dosis en la Temporada 1 y en la Temporada 2.

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

Yes

E.6.6

Pharmacokinetic

Yes

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)

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

palivizumab

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

117

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

Argentina

Australia

Austria

Belgium

Brazil

Bulgaria

Canada

Chile

Colombia

Czech Republic

Estonia

Finland

France

Germany

Hungary

Israel

Italy

Japan

Korea, Republic of

Latvia

Lithuania

Mexico

New Zealand

Panama

Poland

Russian Federation

South Africa

Spain

Sweden

Turkey

Ukraine

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

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

The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study.

El final del estudio ("finalización del estudio") se define como la fecha de la última visita / evaluación especificada en el protocolo (incluido el contacto telefónico) para el último sujeto del estudio.

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 years

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:

1500

F.1.1.1

In Utero

F.1.1.2

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

Yes

F.1.1.2.1

Number of subjects for this age range:

1000

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

1450

F.1.1.5

Children (2-11years)

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

The study is conducted in infants in their first year of life.

El estudio se realiza en lactantes en su primer año de vida.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

350

F.4.2

For a multinational trial

F.4.2.1

In the EEA

890

F.4.2.2

In the whole clinical trial

1500

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

Ninguno

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

2019-09-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-08-08

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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