Clinical Trials Register

Summary
EudraCT Number:	2021-000104-38
Sponsor's Protocol Code Number:	MEQ00073
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-05-18
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2021-000104-38

A.3

Full title of the trial

A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of the Priming Dose of MenACYW Conjugate Vaccine in Children in the European Union who had been Vaccinated 5 Years Earlier as Toddlers with MenACYW Conjugate Vaccine as Part of the MET51 Study

A MenACYW konjugált vakcina kezdőadagja immunperzisztenciájának leírására, valamint az emlékeztető oltás immunogenitásának és biztonságosságának értékelésére irányuló IIIb fázisú, nyílt, többközpontú vizsgálat az Európai Unióban 5 évvel korábban, kisgyermekként, a MET51 vizsgálat keretében MenACYW konjugált vakcinával oltott gyermekeknél

A.3.1

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

Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a Booster Dose in Children Vaccinated 5 Years Earlier as Toddlers

Egy emlékeztető dózisként alkalmazott kvadrivalens, meningococcus elleni, konjugált vizsgálati vakcina (MenACYW konjugált vakcina) vizsgálata 5 évvel korábban, kisgyermekként oltott gyermekeknél

A.4.1

Sponsor's protocol code number

MEQ00073

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1255-4941

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
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 Pasteur SA
B.5.2	Functional name of contact point	Medical Affairs Europe
B.5.3	Address:
B.5.3.1	Street Address	14 Espace Henry Vallée
B.5.3.2	Town/ city	Lyon
B.5.3.3	Post code	69007
B.5.3.4	Country	France
B.5.4	Telephone number	+33437 37 7525
B.5.6	E-mail	isabelle.bertrand-gerentes@sanofi.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	MenQuadfi - TM
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur
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	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	Neisseria Meningitidis Serogroup A Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
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	Neisseria Meningitidis Serogroup C Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
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	Neisseria Meningitidis Serogroup Y Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
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	Neisseria Meningitidis Serogroup W Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
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	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

Meningococcal infection

Meningococcus fertőzés

E.1.1.1

Medical condition in easily understood language

Meningococcal infection

Meningococcus fertőzés

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 vaccine seroresponse sufficiency of meningococcal serogroups A, C, W, and Y after the administration of a booster dose of MenACYW conjugate vaccine in participants who received 1 dose of MenACYW conjugate vaccine approximately 5 years earlier

Annak bemutatása, hogy az A, C, W és Y meningococcus szerocsoport esetében a vakcina szero-válasza elégséges-e, miután egy MenACYW konjugált vakcinával történt emlékeztető oltást adtak be azoknak a résztvevőknek, akik körülbelül 5 évvel korábban 1 dózis MenACYW konjugált vakcinát kaptak

E.2.2

Secondary objectives of the trial

To describe in children who received 1 dose of MenACWY conjugate vaccine approximately 5y earlier:
- the antibody (Ab) persistence of meningococcal serogroups A, C, W, and Y before the administration of a booster dose of this vaccine
- the Ab responses to meningococcal serogroups A, C, W, and Y before and 30d after the administration of a booster dose of this vaccine
- the Ab responses to tetanus toxoid before and 30d after the administration of a booster dose of this vaccine
- the kinetics of Ab titers against meningococcal serogroups A, C, W, and Y in the first 60 participants, before, 6d and 30d after a booster dose of this vaccine
- the Ab responses to meningococcal serogroup C before and 30d after a booster dose of MenACYW conjugate vaccine in children who received this vaccine approximately 5y earlier as meningococcal vaccine naïve toddlers (MET51-Group 1) or as meningococcal C-primed toddlers (MET51-Group 3)
- the safety profile of a booster dose of this vaccine

A kb. 5 évvel ezelőtt MenACYW konjugált vakcina 1 adagjával beoltott gyermekekre vonatkozóan leírni az alábbiakat:
-Az A, C, W és Y meningococcus szerocsoport antitest (AT)-tartóssága az emlékeztető vakcina beadása előtt
-A meningococcus A, C, W és Y szerocsoportra adott AT-válasz az emlékeztető oltás beadása előtt és 30 nappal utána.
-A tetanusz toxoidra adott AT-válasz az emlékeztető oltás beadása előtt és 30 nappal utána.
-Az A, C, W és Y szerocsoport elleni AT-titerek kinetikája az első 60 résztvevőnél a vakcina emlékeztető dózisának beadása előtt, és 6 nappal, illetve 30 nappal azután
-A meningococcus C szerocsoport elleni AT-válaszok a MenACYW konjugált vakcina emlékeztető oltásának beadása előtt, majd 30 nappal azután azoknál a gyermekeknél, akik kb. 5 évvel korábban kapták a vakcinát, meningococcus vakcinával még nem kezelt kisgyermekként (MET51 1. csoport) vagy meningococcus C-vel először oltott kisgyermekként (MET51 3. csoport).
-Az oltás biztonságossági profilja

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
- Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
- Covered by health insurance, if required by local regulations
- Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, if required by local regulations

-A MET51 vizsgálatban MenACYW vakcinát kaptak (1. és 3. csoport) és befejezték a vizsgálatot (részt vettek a 2. viziten)
-A résztvevő aláírta és dátumozta a hozzájárulási nyilatkozatot (amennyiben szükséges) és a szülő vagy törvényes képviselő, illetve független tanú (amennyiben a helyi szabályozások előírják) aláírta és dátumozta a tájékoztatás utáni beleegyező nyilatkozatot.
-A résztvevő és a szülő/törvényes képviselő képes az összes tervezett viziten részt venni és eleget tenni az összes vizsgálati eljárásnak
-Rendelkezik egészségbiztosítással, amennyiben a helyi szabályozások ezt előírják

E.4

Principal exclusion criteria

- 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
- At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
- Personal history of Guillain-Barré syndrome (GBS)
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 and of Meningococcal B vaccine
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

A résztvevők nem alkalmasak a vizsgálatra, ha bármelyik alábbi feltétel teljesül:
-A vizsgálatba való bevonás időpontjában (vagy a vizsgálati vakcina adása előtti 4 hétben) való részvétel vagy a jelen vizsgálat tartama alatt tervezett részvétel másik, vakcinával, gyógyszerrel, orvosi eszközzel vagy eljárással folytatandó klinikai vizsgálatban.
-Korábbi vakcináció a meningococcus betegséggel szemben akár a vizsgálati vakcinával vagy más vakcinával (azaz mono- vagy polivalens, poliszacharid vagy konjugált meningococcus elleni védőoltás, ami tartalmazza az A, C, W vagy Y szerocsoportot), kivéve az engedélyezett MenC csecsemőkori védőoltást (MET51 3. csoport), a MET51 vizsgálat keretében kapott egyadagos meningococcus vakcinát, és a Meningococcus B vakcinát.
-A vizsgálati oltást megelőző 4 hétben történt, vagy a vizsgálati oltást követő 4 hétben tervezett egyéb oltás, kivéve az influenzaoltást, ami a vizsgálat előtt vagy után minimum 2 héttel beadható. Ez a kivétel a monovalens pandémiás influenza vakcinákra és a multivalens influenza vakcinákra terjed ki.
-Immunglobulinok, vér vagy véreredetű készítmények beadása az elmúlt 3 hónapban
-Ismert, vagy feltételezett veleszületett vagy szerzett immunhiány, vagy immunszupresszáns terápia mint pl. daganatellenes kemoterápia vagy sugárterápia a vizsgálati oltást megelőző 6 hónapban, vagy hosszú távú szisztémás kortikoszteroid-terápia (prednizon vagy azzal ekvivalens készítmény használata több mint 2 egymást követő héten az elmúlt 3 hónapban)
-Meningococcus fertőzés kórelőzménye, amelyet klinikailag, szerológiailag vagy mikrobiológiailag megerősítettek.
-Meningococcus fertőzés magas kockázata a vizsgálat ideje alatt (kifejezetten, de nem kizárólag olyan résztvevők, akiknek tartós komplementhiányuk van, anatómiai vagy funkcionális asplenia, vagy olyan résztvevők, akik erősen járvány sújtotta országokba terveznek utazni)
-GBS (Guillain-Barré szindróma) a kórtörténetben
-Korábbi Arthus-szerű reakció tetanus toxoidot tartalmazó oltás után
-Ismert szisztémás túlérzékenység a vakcina bármely összetevőjére, vagy életveszélyes reakciók a vizsgálatban használandó vakcinára, vagy egy korábbi, ugyanezen összetevők valamelyikét tartalmazó oltásra
-A szülő(k) vagy a törvényes képviselő által jelentett vagy gyanított trombocitopénia, ebben az esetben nem javallott az IM adagolás
-Vérzési rendellenesség, vagy alvadásgátló szedése a vizsgálat előtti 3 hétben, ebben az esetben nem javallott az IM adagolás
-Közigazgatási vagy bírósági végzés miatti szabadságvesztés vagy vészhelyzet vagy nem önkéntes kórházi ellátás
-Olyan krónikus betegség , ami a vizsgálóorvos megítélése szerint megzavarhatja a vizsgálat folyamatát, vagy annak befejezését
-(A vizsgálatvezető megítélése szerint) mérsékelt vagy súlyos akut betegség/fertőzés az oltás napján, illetve lázas megbetegedés (≥ 38,0° C testhőmérséklet). A potenciális résztvevőt nem szabad bevonni, amíg az adott betegség nem oldódott meg, vagy a lázas esemény el nem múlt.
-Orálisan vagy injekció formájában alkalmazott antibiotikum-terápia az első vérvételt megelőző 72 órán belül.
-A vizsgálatvezető vagy a javasolt vizsgálatban közvetlenül részt vevő alkalmazott saját, illetve adoptált gyermeke.

E.5 End points

E.5.1

Primary end point(s)

Vaccine seroresponse against meningococcal serogroups A, C, W, and Y; Antibody titers measured by serum bactericidal assay using human complement (hSBA),
Seroresponse defined as the proportions of participants with an hSBA pre-vaccination titer < 1:8 who achieved a post-vaccination titer ≥ 1:16 or participants with a pre-vaccination titer ≥ 1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 01 (pre-vaccination) and Day 31 (postvaccination)

E.5.2

Secondary end point(s)

1. Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA)
2. Antibody titers against meningococcal serogroups A, C, W, and Y before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and rSBA
3. Antibody concentrations against tetanus toxoid before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody concentration measured by immunoglobulin (Ig)G enzyme-linked immunosorbent assay (ELISA)
4. Antibody titers against meningococcal serogroups A, C, W, and Y before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and rSBA in a subset of first 60 participants
5. Antibody titers against meningococcal serogroup C before and after the administration of a booster dose of MenACYW conjugate vaccine; Antibody titers measured by hSBA and rSBA
6. Number of participants with immediate adverse events (AEs); Unsolicited systemic AEs reported within 30 minutes after vaccination
7. Number of participants with solicited injection site reactions or systemic reactions; Pre-defined adverse reactions
Injection site reactions: pain, redness and swelling
Systemic reactions: fever, headache, malaise, myalgia
8. Number of participants with unsolicited AEs; AEs other than solicited reactions
9. Number of participants with serious adverse events (SAEs); SAEs (including adverse events of special interest [AESIs]) reported throughout the study

E.5.2.1

Timepoint(s) of evaluation of this end point

1: Day 01 (pre-vaccination)
2, 3, 5: Day 01 (pre-vaccination) and Day 31 (post-vaccination)
4: Day 01 (pre-vaccination), Day 07 and Day31 (post-vaccination)
6: Within 30 minutes after vaccination
7: Within 7 days after vaccination
8, 9: Within 30 days after vaccination

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

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

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:

250

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:

250

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

250

F.4.2.2

In the whole clinical trial

250

F.5

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

None

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-06-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-15

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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