Clinical Trials Register

Summary
EudraCT Number:	2020-001665-37
Sponsor's Protocol Code Number:	MEQ00071
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-15
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-001665-37

A.3

Full title of the trial

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly with 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents

Studio di immunogenicità e sicurezza di un vaccino coniugato meningococcico quadrivalente rispetto a Nimenrix®, quando somministrato in monoterapia o in concomitanza con i vaccini 9vHPV e Tdap-IPV in adolescenti sani

A.3.1

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

Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or Concomitantly with Two Other Vaccines in Healthy Adolescents

Studio di un vaccino coniugato meningococcico quadrivalente (vaccino coniugato MenACYW) rispetto a un vaccino di riferimento meningococcico, quando somministrato in monoterapia o in concomitanza con altri due vaccini in adolescenti sani

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

MEQ00071

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1249-2973

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SANOFI PASTEUR
B.1.3.4	Country	France
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 SA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SANOFI S.p.A.
B.5.2	Functional name of contact point	Contact Point
B.5.3	Address:
B.5.3.1	Street Address	Viale Luigi Bodio 37/B
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20158
B.5.3.4	Country	Italy
B.5.4	Telephone number	800226343
B.5.5	Fax number	0239394168
B.5.6	E-mail	informazioni.medicoscientifiche@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	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.3.1	Product name	vaccino coniugato MenACYW
D.3.2	Product code	[395]
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	polisaccaride di Neisseria Meningitidis Gruppo A coniugato al tossoide tetanico come proteina carrier
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36479
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polisaccaride di Neisseria Meningitidis Sierogruppo C coniugato al tossoide tetanico
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
D.3.9.4	EV Substance Code	SUB31471
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polisaccaride di Neisseria Meningitidis Gruppo Y coniugato al tossoide tetanico come proteina carrier
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36482
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polisaccaride di Neisseria Meningitidis Gruppo W coniugato al tossoide tetanico come proteina carrier
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36481
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Nimenrix
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	Nimenrix
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Powder and solvent for 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	Polisaccaride di Neisseria Meningitidis Gruppo A coniugato al tossoide tetanico come proteina carrier
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36479
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polisaccaride di Neisseria Meningitidis Sierogruppo C coniugato al tossoide tetanico
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
D.3.9.4	EV Substance Code	SUB31471
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polisaccaride di Neisseria Meningitidis Gruppo W coniugato al tossoide tetanico come proteina carrier
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36481
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Polisaccaride di Neisseria Meningitidis Gruppo Y coniugato al tossoide tetanico come proteina carrier
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36482
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 3
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	GARDASIL® 9
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD VACCINS
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	GARDASIL® 9
D.3.2	Product code	[NA]
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	proteina L1 HPV 6
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22591
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 11
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22592
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 16
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22593
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	60
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 18
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22594
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 31
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130868
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 33
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130869
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 45
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130870
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 52
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130871
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	proteina L1 HPV 58
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130872
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	20
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 4
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	ADACEL®-POLIO
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	ADACEL®-POLIO
D.3.2	Product code	[NA]
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	Tossoide tetanico
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB12608MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	tossoide difterico
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	DIPHTHERIA TOXOID
D.3.9.4	EV Substance Code	SUB12489MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	tossoide pertossico
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PERTUSSIS TOXOID
D.3.9.4	EV Substance Code	SUB14817MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ng nanogram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	emagglutinina filamentosa
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	FILAMENTOUS HAEMAGGLUTININ
D.3.9.4	EV Substance Code	SUB38509
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertactina
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PERTUSSIS PERTACTIN
D.3.9.4	EV Substance Code	SUB20527
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	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fimbrie di tipo 2 e 3
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	PERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3
D.3.9.4	EV Substance Code	SUB25272
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vaccino per la poliomielite inattivato di tipo 1 (Mahoney)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN)
D.3.9.4	EV Substance Code	SUB25292
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vaccino per la poliomielite inattivato di Tipo 2 (MEF-1)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN)
D.3.9.4	EV Substance Code	SUB25266
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vaccino per la poliomielite inattivato di Tipo 3 (Saukett)
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN)
D.3.9.4	EV Substance Code	SUB25264
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Meningococcal infection

Infezione meningococcica

E.1.1.1

Medical condition in easily understood language

Meningococcal infection

Infezione meningococcica

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10027274
E.1.2	Term	Meningococcal infection
E.1.2	System Organ Class	10021881 - Infections and infestations

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-inferiority of the seroprotection rate (serum bactericidal assay using human complement [hSBA] titer >= 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of MenACYW conjugate vaccine (Group 1) compared to a single dose of Nimenrix® (Group 2).

Dimostrare la non inferiorità del tasso di sieroprotezione (saggio battericida sierico con complemento umano [hSBA], titolo >= 1:8) contro i sierogruppi meningococcici A, C, W e Y in seguito alla somministrazione di una singola dose del vaccino coniugato MenACYW (Gruppo 1) rispetto ad una singola dose di Nimenrix® (Gruppo 2).

E.2.2

Secondary objectives of the trial

To describe:
- the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine [adsorbed, reduced antigen(s) content] (Tdap-IPV) vaccines (Group 3)
- the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination
- the safety profile in each group after each and any vaccination.

Descrivere:
- la risposta anticorpale dei sierogruppi meningococcici A, C, W e Y misurata tramite hSBA, prima e 1 mese dopo la vaccinazione meningococcica somministrata in monoterapia (Gruppi 1 e 2) o in concomitanza con i vaccini 9vHPV e Tdap-IPV (Gruppo 3)
- la risposta anticorpale contro gli antigeni dei vaccini 9vHPV e Tdap-IPV, prima e 1 mese dopo la vaccinazione
-il profilo di sicurezza di ciascun gruppo dopo ogni singola vaccinazione.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Aged 10 to 17 years on the day of inclusion ("10 to 17 years" means from the day of the 10th birthday to the day before the 18th birthday)
- Meningococcal C conjugate (MenC) naïve participants or participants having received monovalent MenC priming in infancy (< 2 years of age)
- Assent form has been signed and dated by the participant, and informed consent form has been signed and dated by the parent/ legally acceptable representative
- Participants and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
- Covered by health insurance, if required by local regulations.

- Età da 10 a 17 anni il giorno dell’inclusione (“da 10 a 17 anni” significa dal giorno del 10° compleanno al giorno prima del 18° compleanno)
- Partecipanti naïve al vaccino coniugato meningococcico di sierogruppo C (MenC) o partecipanti che hanno ricevuto la vaccinazione primaria monovalente MenC durante l’infanzia (< 2 anni di età)
- Il modulo di assenso è stato firmato e datato dal partecipante e il modulo di consenso informato è stato firmato e datato dal genitore/rappresentante legalmente riconosciuto
- Il partecipante e il genitore/rappresentante legalmente riconosciuto sono in grado di presentarsi a tutte le visite programmate e di seguire tutte le procedure dello studio
- Copertura di assicurazione sanitaria, se richiesta dalle normative locali.

E.4

Principal exclusion criteria

- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche
- Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years
- Previous human papilloma virus (HPV) vaccination
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- 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)
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
- Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease. At high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
- Personal history of Guillain-Barré syndrome
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination
- Personal history of new or past encephalopathy, progressive or unstable neurological disorder, or unstable epilepsy
- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C [>= 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

- La partecip. è incinta o in allatt. o è in età fertile e non usa un metodo efficace di contracc. o non ha praticato astinenza da almeno 4 sett prima della vaccinaz. fino ad almeno 4 sett. dopo l’ultima vaccinaz. Per essere considerata non in età fertile, la partecip. deve essere in fase pre-menarca
- Preced. vaccinaz. contro malattia meningococcica con il vaccino dello studio o altro vaccino (es. polisaccaride o vaccino coniugato meningococcico contenente i sierogruppi A,C,W o Y oppure vaccino meningococcico contenente il sierogruppo B), tranne la vaccinaz. MenC monovalente autorizz. ricevuta prima dei 2 anni di età
- Partecip. al momento dell’arruolam. allo studio (o nelle 4 sett. preced. alla prima vaccinaz. dello studio) o intenzione di partecip. nel corso del presente studio a un altro studio clinico su un vaccino, farmaco, disp. medico o proced. medica
- Somm.ne di un vaccino nelle 4 sett. precedenti a una vaccinaz. dello studio o intenzione di ricevere un vaccino nelle 4 sett. successive a una vaccinaz. dello studio, tranne la vaccinaz. antinfluenzale, che può essere somministrata almeno 2 sett. prima dei vaccini dello studio. Questa eccezione include i vaccini antinfluenzali pandemici monovalenti e i vaccini antinfluenzali polivalenti.
- Anamnesi di vaccinaz. con virus di tetano, difterite, pertosse o polio inatt. nei 3 anni precedenti
- Precedente vaccinaz. contro il papilloma virus umano (HPV)
- Somm.ne di immunoglobuline, sangue o prodotti emoderivati negli ultimi 3 mesi
- Immunodef. congenita o acquisita nota o sospetta; somm.ne di terapia immunosoppressiva, come chemioterapia o radioterapia antitumorale, nei 6 mesi precedenti; terapia sistemica a lungo termine con corticosteroidi (prednisone o equiv. per più di 2 sett. consecutive negli ultimi 3 mesi)
- Anamnesi di infez. meningococcica, confermata a livello clinico, sierologico o microbiologico
- Anamnesi nota di difterite, tetano, pertosse, poliomielite e/o infezione o patologia da HPV. Alto rischio di infezione meningococcica durante lo studio (nello specifico, a titolo non limitativo, partecipanti con carenze del complemento persistenti, con asplenia anatomica o funzionale o partecipanti che viaggiano in Paesi ad alto rischio di malattie endemiche o epidemiche).
- Ipersens. sistemica nota a un componente del vaccino o anamnesi di reazione potenzialmente letale ai vaccini utilizzati nello studio o a un vaccino contenente una delle stesse sostanze
- Anamnesi personale di sindrome di Guillain-Barré
- Anamnesi personale di fenomeno simile alla reazione di Arthus dopo un vaccino contenente tossoide tetanico in un periodo pari almeno ai 10 anni precedenti alla vaccinaz. dello studio proposta
- Anamnesi personale di encefalopatia, disturbo neurologico progr. o instabile o epilessia instabile, di nuova insorgenza o passata
- Segnalaz. verbale di trombocitopenia, che rende la vaccinaz. intram. controindicata
- Disturbo da sanguin. o somm.ne di anticoag. nelle 3 sett. precedenti all’inclusione, che rende la vaccinaz. intram. controindicata
- Privaz della libertà per mezzo di ordinan. Amm. o di tribunale o ricovero in pronto soccorso o ricovero osp. coatto
- Attuale abuso di alcool o tossicodip.
- Malattia cronica che, a giudizio del PI, si trova a uno stadio in cui potrebbe interferire con la conduz. o il complet. dello studio
- Malattia/infez. acuta moderata o grave (a giudizio dello Sperimentatore) il giorno della vaccinaz. o malattia febbrile (temperatura >= 38,0 °C [>= 100,4 °F]). Il potenziale partecipante non deve essere incluso nello studio finché la condiz. non si è risolta o l’evento febbrile non si è ridotto
- Somm.ne di terapia antibiotica orale o per iniezione nelle 72 ore precedenti al primo prelievo di sangue
- Sogg. identificato come PI o dip. del PI o del centro dello studio con coinvolg. diretto nello studio proposto o come parente stretto (es. genitore, coniuge, figlio naturale o adottato) del PI o dip. con coinvolg. diretto nello studio proposto.

E.5 End points

E.5.1

Primary end point(s)

Seroprotection against meningococcal serogroups A, C, W, and Y: Group 1 and Group 2; Antibody titers measured by hSBA in Groups 1 and 2 Seroprotection defined as antibody titer equal or greater than (>=) 1:8.

Sieroprotezione contro i sierogruppi meningococcici A, C, W e Y: Gruppo 1 e Gruppo 2; titoli anticorpali misurati tramite hSBA nei Gruppi 1 e 2 Sieroprotezione definita come titolo anticorpale uguale o maggiore >= 1:8.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 31

Giorno 31

E.5.2

Secondary end point(s)

1 - Antibody titers against meningococcal serogroups A, C, W, and Y; Antibody titers measured by hSBA in each group
2 - Antibodies titers against antigens contained in Tdap-IPV vaccine: Group 1 and Group 2; Anti-Polio 1, 2, and 3 antibody titers measured in Group 1 and Group 2
3 - Antibodies titers against antigens contained in Tdap-IPV vaccine: Group 3; Anti-Polio 1, 2, and 3 antibody titers measured in Group 3
4 - Antibodies concentrations against antigens contained in Tdap-IPV vaccine: Group 1 and Group 2; Anti-tetanus, anti-diphtheria and antipertussis antibody concentrations measured in Group 1 and Group 2
5 - Antibodies concentrations against antigens contained in Tdap-IPV vaccine: Group 3; Anti-tetanus, anti-diphtheria and anti-pertussis antibody concentrations measured in Group 3
6 - Antibodies titers against antigens contained in HPV vaccine: Group 1 and Group 2; Anti-HPV antibody titers measured in Group 1 and Group 2
7 - Antibodies titers against antigens contained in HPV vaccine: Group 3; Anti-HPV antibody titers measured in Group 3
8 - Number of participants reporting immediate adverse events (AEs); Unsolicited systemic AEs reported in the 30 minutes after each vaccination
9 - Number of participants reporting solicited injection site reactions and systemic reactions; Solicited (prelisted in the participant's diary card and [electronic] Case Report Form [CRF]) injection site and systemic reactions starting any time from the day of vaccination through 7 days after each vaccination
Injection site reactions: pain, erythema and swelling
Systemic reactions: fever, headache, malaise, myalgia
10 - Number of participants reporting unsolicited non-serious AEs; Unsolicited (recorded in a diary card) non-serious AEs reported up to 30 days after each vaccination
11 - Number of participants reporting serious adverse events (SAEs) ; Serious adverse events (SAEs) (including adverse events of special interest [AESIs]) reported throughout the study, i.e., from Day 01 (first vaccination) to the last study day (Day 61 for Groups 1 and 2 and Day 31 for Group 3).

1- Titoli anticorpali contro i sierogruppi meningococcici A, C, W e Y; titoli anticorpali misurati tramite hSBA in ciascun gruppo
2- Titoli anticorpali contro gli antigeni contenuti nel vaccino Tdap-IPV: Gruppo 1 e Gruppo 2; Titoli anticorpali anti-polio 1, 2 e 3 misurati nel Gruppo 1 e nel Gruppo 2
3- Titoli anticorpali contro gli antigeni contenuti nel vaccino Tdap-IPV: Gruppo 3; Titoli anticorpali anti-polio 1, 2 e 3 misurati nel Gruppo 3
4- Concentrazioni anticorpali contro gli antigeni contenuti nel vaccino Tdap-IPV: Gruppo 1 e Gruppo 2; concentrazioni anticorpali anti-tetano, anti-difterite e anti-pertosse misurate nel Gruppo 1 e nel Gruppo 2
5- Concentrazioni anticorpali contro gli antigeni contenuti nel vaccino Tdap-IPV: Gruppo 3; concentrazioni anticorpali anti-tetano, anti-difterite e anti-pertosse misurate nel Gruppo 3
6- Titoli anticorpali contro gli antigeni contenuti nel vaccino HPV: Gruppo 1 e Gruppo 2; Titoli anticorpali anti-HPV misurati nel Gruppo 1 e nel Gruppo 2
7- Titoli anticorpali contro gli antigeni contenuti nel vaccino HPV: Gruppo 3; Titoli anticorpali anti-HPV misurati nel Gruppo 3
8- Numero di partecipanti che riportano eventi avversi (AE) immediati; Eventi avversi (AE) sistemici, non sollecitati, segnalati nei 30 minuti successivi a ogni vaccinazione
9- Numero di partecipanti che riportano reazioni sistemiche e reazioni nel sito di iniezione sollecitate; reazioni sistemiche e reazioni nel sito di iniezione sollecitate (pre-elencate nella scheda giornaliera del partecipante e nella scheda di raccolta dati [CRF] [elettronica]) che iniziano in qualsiasi momento dal giorno della vaccinazione fino a 7 giorni dopo ogni vaccinazione
Reazioni nel sito di iniezione: dolore, eritema e gonfiore
Reazioni sistemiche: febbre, mal di testa, malessere, mialgia
10- Numero di partecipanti che riportano AE non gravi, non sollecitati; AE non gravi, non sollecitati (registrati in una scheda giornaliera), segnalati fino a 30 giorni dopo ogni vaccinazione
11- Numero di partecipanti che riportano Eventi avversi gravi (SAE); Eventi avversi gravi (SAE) (inclusi eventi avversi di particolare interesse [AESI]) segnalati durante tutto lo studio, ovvero dal G01 (prima vaccinazione) all’ultimo giorno dello studio (G61 per i Gruppi 1 e 2 e G31 per il Gruppo 3)

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 3, 5, 7 : Day 01 (pre-vaccination) and Day 31 (post-vaccination)
2, 4, 6 : Day 31 (pre-vaccination) and Day 61 (post-vaccination)
8 : Within 30 minutes post-vaccination
9 : Within 7 days post-vaccination
10 : Within 30 days post-vaccination
11 : Up to Day 61 post-vaccination

1, 3, 5, 7 : G01 (pre-vaccinazione) e G31 (post-vaccinazione)
2, 4, 6 : G31 (pre-vaccinazione) e G61 (post-vaccinazione)
8 : entro 30 minuti post-vaccinazione
9 : entro 7 giorni post-vaccinazione
10 : entro 30 giorni post-vaccinazione
11: fino al G61 post-vaccinazione

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

immunogenicità

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

Information not present in EudraCT

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

Singapore

Hungary

Italy

Spain

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

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

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.1.1.1

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:

232

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

232

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

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

Children and Adolescents

bambini e adolescenti

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

464

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

nessuno

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

2020-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-10-05

P. End of Trial
P.	End of Trial Status	Ongoing

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