Clinical Trials Register

Summary
EudraCT Number:	2013-002454-78
Sponsor's Protocol Code Number:	V72_62
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-12-16
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

2013-002454-78

A.3

Full title of the trial

A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine when administered to Immunocompromised Patients from 2 to 17 years of age who are at Increased Risk of Meningococcal Disease because of Complement Deficiency or Asplenia compared to matched Healthy Controls

Studio multicentrico di fase IIIb, controllato, in aperto, per valutare la sicurezza, tollerabilità e immunogenicità di due dosi del vaccino Novartis contro il meningococco di gruppo B somministrato a pazienti immunocompromessi tra i 2 e i 17 anni di età che presentano un rischio più elevato di sviluppare la malattia meningococcica a causa di un deficit del complemento o asplenia, rispetto a un gruppo di controllo formato da soggetti sani’

A.3.1

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

Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.

Studio in pazienti immunocompromessi da 2 a 17 anni, che sono a rischio di contrarre la malattia da meningocococco B, in quanto soggetti privi della milza o che presentano difetti nel complemento. Lo scopo dello studio è di valutare la sicurezza, tollerabilità e la risposta anticorpale dopo la somministrazione di 2 dosi del vaccino in studio, prodotto da NVD e diretto contro il Meningococco B, paragonando i risultati con quelli del gruppo di controllo costituito da soggetti sani .

A.4.1

Sponsor's protocol code number

V72_62

A.5.4

Other Identifiers

Name:

Not applicable

Number:

Not applicable

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/38/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Vaccines and Diagnostics S.r.l.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Vaccines and Diagnostics S.r.l.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Vaccines and Diagnostics S.r.l.
B.5.2	Functional name of contact point	Clinical Cluster
B.5.3	Address:
B.5.3.1	Street Address	Via Fiorentina 1
B.5.3.2	Town/ city	Siena
B.5.3.3	Post code	53100
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 0577539588
B.5.5	Fax number	+390577539236
B.5.6	E-mail	marco.calabresi@novartis.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Bexsero, meningococcal group-B vaccine
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Vaccines and Diagnostics, srl
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	Meningococcal Group B Vaccine (Bexsero)
D.3.2	Product code	rMenB+OMV NZ
D.3.4	Pharmaceutical form	Suspension 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	not applicable
D.3.9.2	Current sponsor code	not applicable
D.3.9.3	Other descriptive name	N. meningitidis group B 936-741 purified antigen
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not applicable
D.3.9.2	Current sponsor code	not applicable
D.3.9.3	Other descriptive name	N. meningitidis group B 287-953 purified antigen
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not applicable
D.3.9.2	Current sponsor code	not applicable
D.3.9.3	Other descriptive name	N. meningitidis group B 961c purified antigen
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not applicable
D.3.9.2	Current sponsor code	not applicable
D.3.9.3	Other descriptive name	OMV from N. meningitidis Strain NZ 98/254
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	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.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 Group B disease.

Malattia del Maningococco di gruppo B

E.1.1.1

Medical condition in easily understood language

Meningitidis.

Meningite

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	16.1
E.1.2	Level	PT
E.1.2	Classification code	10027202
E.1.2	Term	Meningitis bacterial
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

Immunogenicity Objective
▫ To evaluate the immunogenicity of two doses of rMenB+OMV NZ in subjects with
increased risk of meningococcal disease because of complement deficiency or
asplenia and in healthy age-matched subjects, at 1 month after the second
vaccination.
Safety Objective
▫ To assess the safety and tolerability of two doses of rMenB+OMV NZ in subjects
with increased risk of meningococcal disease because of complement deficiency or
asplenia and in healthy age-matched subjects.

Obiettivo di immunogenicità
• Valutare l’immunogenicità di due dosi di rMenB+OMV NZ nei soggetti che presentano un rischio più elevato di sviluppare la malattia meningococcica a causa di deficit del complemento o asplenia e in soggetti sani della stessa età, a 1 mese di distanza dalla seconda vaccinazione.
Obiettivo di sicurezza
Valutare la sicurezza e tollerabilità di due dosi di rMenB+OMV NZ nei soggetti che presentano un rischio più elevato di sviluppare la malattia meningococcica a causa di deficit del complemento o asplenia e in soggetti sani della stessa età.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria applicable to the relevant group.
Inclusion criteria applicable to All Groups (A, B and C)
1. Subjects aged 2 to 17 years (inclusive) at enrollment;
2. who have given written informed assent (if appropriate) and whose parent/legal guardian have given written informed consent after the nature of the study has been explained;
3. available for all the visits scheduled in the study;
4. weighing at least 13 Kg at the time of enrollment.
Inclusion criterion applicable to Group A
5. Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies:
a. Primary deficiencies: patients with a congenital condition leading to a reduced concentration of one or more proteins in the complement cascade, including C1 (q,r,s), C2, C3, C4, Factor D, Properdin, C5, C6, C7, C8, C9, Factor H, Factor I (homozygous)
b. Secondary deficiencies: patients with a condition indirectly leading to a reduced concentration of one or more proteins in the complement cascade, including patients who are already in treatment with eculizumab at the time of enrollment and have been diagnosed with paroxysmal nocturnal hemoglobinuria or with atypical hemolytic uremic syndrome
For patients with a secondary complement deficiency the investigator should include in the source documentation evidence of the increased risk of meningococcal disease based on reduced complement protein concentrations or on previous meningococcal infection. This should be documented in the medical records.
Inclusion criterion applicable to Group B
6. Subjects at risk of meningococcal disease because of functional or anatomic asplenia:
a. Congenital anomalies of the spleen, isolated or in association with other splenic anomalies
b. Surgical splenectomy, which may occur after significant splenic trauma or other clinical disorders, such as idiopathic (autoimmune) thrombocytopenic purpura
c. Autosplenectomy (i.e. infarction) which may occur in patients with sickle cell disease or other haemoglobinopathies
For patients with functional asplenia the investigator will collect medical documentation for reduced splenic function diagnosed with an appropriate technique. Patients with anatomic asplenia or sickle-cell disease do not require assessment of the splenic function.
Inclusion criterion applicable to Group C
7. healthy immunocompetent subjects, in good health as determined by medical history, physical examination and clinical judgment of the investigator.

Criteri di Inclusione applicabili a Tutti i Gruppi (A, B e C)
1.Soggetti che al momento dell’arruolamento abbiano un’età compresa tra i 2 e i 17 anni
2.Soggetti che hanno dato il consenso informato scritto (se appropriato) e per quegli individui il cui genitore / tutore legale ha dato consenso informato scritto, dopo che gli è stata spiegata la natura dello studio
3.Disponibili a partecipare a tutte le visite programmate
4.Individui che pesano almeno 13 Kg al momento dell’arruolamento

Criteri di inclusione applicabili al Gruppo A

5.Soggetti ad alto rischio di infezione da meningococco a causa di una deficienza primaria o secondaria del complemento
a. Deficienza Primaria: pazienti con una condizione congenita che ha portato a una riduzione della concentrazione di una o di più proteine coinvolte nella reazione a cascata del complemento, incluso il C1 (q.r.s.), C2, C3, C4, Fattore D, Properdina, C5, C6, C7, C8, C9, Fattore H, Fattore I (omozigoti)
b. Deficienza secondaria: pazienti la cui condizione porta indirettamente a una riduzione della concentrazione di una o di più proteine coinvolte nella reazione a cascata del complemento, inclusi quei pazienti che sono sotto trattamento con eculizumab al momento dell’arruolamento e ai quali è stata diagnosticata emoglobinuria parossistica notturna oppure la sindrome emolitico-uremica atipica Per i pazienti con deficienza secondaria del complemento , lo sperimentatore dovrà riportare in cartella clinica l’evidenza del rischio di meningite basata sulla riduzione della concentrazione delle proteine del complemento oppure su precedenti infezioni meningococciche.
Il tutto dovrà essere documentato nelle cartelle cliniche
Criteri di Inclusione applicabili al Gruppo B
6. Soggetti con rischio d’infezione da meningococco dovuta ad asplenia funzionale o cronica:
c. Anomalie congenite della milza, isolate o in associazione con altre anomalie della milza.
d. Rimozione chirurgica della milza, avvenuta dopo un importante trauma della milza o dopo altri disordini clinici come gli idiopatici per (autoimmune), o Porpora Trombocitopenica
Autosplenectomia. (i.e. infarto) la quale può avvenire in pazienti con anemia falciforme oppure con altre emoglobinopatie
Per i pazienti con asplenia funzionale, lo sperimentatore deve raccogliere la documentazione medica che provi la riduzione della funzione splenica diagnosticata con tecniche appropriate. Per i pazienti con asplenia anatomica o con malattia a cellule falciformi non è richiesta una valutazione della funzione splenica.
Criteri di Inclusione applicabili al Gruppo C
Soggetti immunocompetenti sani, in buona salute come dimostrato dall’anamnesi, dall’esame fisico e dal giudizio clinico dello sperimentatore.

E.4

Principal exclusion criteria

Exclusion criteria applicable to All Groups (A, B and C)
1. History of any previous immunization with a meningococcal B vaccine at the time of
enrollment;
2. History of severe allergic reaction after previous vaccinations, or hypersensitivity to
any component of the vaccine;
3. Known HIV infection;
4. History of any progressive or severe neurologic disorder, or seizure disorder
(exception: one self-limited febrile seizure is acceptable);
5. Contraindication to intramuscular injection or blood drawn;
6. Females who are pregnant, planning a pregnancy or nursing (breastfeeding);
7. Females of childbearing potential who have not used or do not plan to use acceptable
birth control measures, for the 3 months duration of the study. Oral, injected or
implanted hormonal contraceptive, barrier methods (diaphragm or condom with
spermicide), intrauterine device or sexual abstinence are considered acceptable forms
of birth control. If sexually active the subject must have been using one of the
accepted birth control methods for at least 60 days prior to study entry
8. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all
required study procedures for the whole period of the study;
9. Intent to participate in another clinical study during this study;
10. Family members or household members of site research staff;
11. History or any illness/condition that, in the opinion of the investigator, might interfere
with the results of the study or pose additional risk to the subjects due to participation
in the study.
Exclusion criterion applicable to Groups A and B
12. Previous known or suspected disease caused by N. meningitidis in the last year;
Exclusion criteria applicable to Group C
13. Previous known or suspected disease caused by N. meningitidis;
14. Known or suspected impairment/alteration of the immune system resulting from, for
example, receipt of immunosuppressive/immunostimulant therapy
There may be instances when individuals meet all entry criteria except one that relates to
transient clinical circumstances (e.g., body temperature elevation or recent use of
excluded medication or vaccine). Under these circumstances, a subject may be
considered eligible for study enrollment if the appropriate window for delay has passed,
inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be
eligible.

Criteri di Esclusione applicabili a Tutti i Gruppi (A, B e C)
Anamnesi di precedenti immunizzazioni con vaccino antimeningococco B, al momento dell’arruolamento
Anamnesi di reazioni allergiche gravi dovute a precedenti vaccinazioni, oppure di ipersensibilità ad ogni componente del vaccino.
Infezioni diagnosticate da HIV.
Anamnesi di disordini neurologici gravi o progressivi, oppure con epilessia (eccezione: un solo episodio di convulsione febbrile è accettabile)
Controindicazioni alle iniezioni intramuscolari o ai prelievi ematici
Donne in gravidanza o che abbiano pianificato una gravidanza e donne che stanno allattando
Donne in età potenzialmente fertile che non usano o non intendo usare misure contraccettive accettabili per i 3 mesi della durata dello studio. Sono considerati metodi contraccettivi validi quelli ormonali orali, iniettati o impiantati, metodi contraccettivi di barriera (diaframmi, o preservativi con crema spermicida), dispositivo intrauterino oppure astinenza sessuale. Se è presente attività sessuale il soggetto deve utilizzare uno dei contraccettivi validi per almeno 60 giorni prima dell’entrata dello studio.
I parenti o tutori legali che non siano in grado di comprendere e di seguire per l’intero periodo dello studio, tutte le procedure richieste.
Soggetti che intendono partecipare a un altro studio clinico durante questo studio.
Familiari o membri dello staff clinico;
Anamnesi o qualsiasi condizione o malattia che, a giudizio dello sperimentatore, possa interferire con i risultati dello studio o che possano porre i soggetti a rischio ulteriori per la partecipazione allo studio.

Criteri di Esclusione applicabili ai Gruppi A e B
Sospetta o malattia nota causata da N. meningitidis nell’ultimo anno.

Criteri di Esclusione applicabili al Gruppo C
Sospetta o malattia nota causata da N. meningitidis.
Nota o sospetta alterazione/insufficienza del sistema immunitario dovuto per esempio all’uso di immunonosoppressori o immunostimolanti.
Ci possono essere casi in cui gli individui rispondono a tutti i criteri di inclusione ad eccezione di uno, che può essere collegato a circostanze transitorie (per esempio temperatura elevata, oppure uso recente di farmaci o di vaccini non permessi dallo studio).
In queste circostanze un individuo può essere considerato idoneo per l’arruolamento allo studio se la ‘finestra’ appropriata per il ritardo è superata e i criteri di inclusione/esclusione sono stati ricontrollati, e il soggetto è confermato essere idoneo.

E.5 End points

E.5.1

Primary end point(s)

Primary Endpoint(s)
▫ Percentage of subjects with hSBA titers ≥ 5, hSBA titers ≥ 8 and hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain at baseline and one month after the second vaccination. Corresponding to the GMTs, within-subject Geometric Mean Ratios (GMRs), at one month after the second vaccination over baseline.
▫ Percentage of subjects with four-fold increases in hSBA titers against each of the serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain at one month after the second vaccination over baseline.
▫ ELISA geometric mean concentrations (GMCs), to evaluate antibody responses to vaccine antigen 287-953, at baseline and at one month after the second vaccination. Corresponding to the GMCs, within-subject ELISA GMRs, at one month after the second vaccination over baseline.
▫ Percentage of subjects with four-fold increases in ELISA concentrations, to evaluate antibody responses to vaccine antigen 287-953, at one month after the second vaccination over baseline.
Safety Endpoints
▫ The frequencies and percentages of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after Visits 1 and 2.
▫ The frequencies and percentages of subjects with any other (unsolicited) AEs including any SAEs, AEs leading to withdrawal and medically attended AEs during the 7 days (including the day of vaccination) after Visits 1 and 2.
▫ The frequencies and percentages of subjects with SAEs, AEs leading to withdrawal and medically attended AEs throughout the study period.

Endpoint di immunogenicità:
• Percentuale di soggetti con titoli hSBA ≥5, titoli hSBA ≥8 e media geometrica dei titoli (Geometric Mean Titers, GMT) hSBA rispetto a ciascun ceppo indicatore del sierogruppo B (H44/76, 5/99 e NZ98/254) e al ceppo M10713 al basale e un mese dopo la seconda vaccinazione. Media geometrica dei rapporti (Geometric Mean Ratios, GMR) tra i soggetti, corrispondente alla media GMT, un mese dopo la seconda vaccinazione sul basale.
• Percentuale di soggetti con un aumento di quattro volte dei titoli hSBA rispetto a ciascun ceppo indicatore del sierogruppo B (H44/76, 5/99 e NZ98/254) e al ceppo M10713 un mese dopo la seconda vaccinazione sul basale.
• Media geometrica delle concentrazioni (Geometric Mean Concentrations, GMC) secondo il metodo ELISA, per valutare le risposte anticorpali all’antigene vaccinico 287-953, al basale e un mese dopo la seconda vaccinazione. GMR ELISA tra i soggetti, corrispondente alla GMC, un mese dopo la seconda vaccinazione sul basale.
• Percentuale di soggetti con un aumento di quattro volte delle concentrazioni ELISA, per valutare le risposte anticorpali all’antigene vaccinico 287-953, un mese dopo la seconda vaccinazione sul basale.
Endpoint di sicurezza:
• Frequenze e percentuali di soggetti che presentano EA locali e sistemici predeterminati durante i 7 giorni (incluso il giorno della vaccinazione) successivi alla Visita 1 e alla Visita 2.
• Frequenze e percentuali di soggetti che presentano qualsiasi altro EA (non predeterminato), compresi EA seri, EA che hanno determinato il ritiro dallo studio e gli EA che hanno richiesto una visita medica durante i 7 giorni (incluso il giorno della vaccinazione) successivi alla Visita 1 e alla Visita 2.
• Frequenze e percentuali di soggetti con EA seri, EA che hanno determinato il ritiro dallo studio ed EA che hanno richiesto una visita medica nel corso di tutto lo studio.

E.5.1.1

Timepoint(s) of evaluation of this end point

Primary Endpoints:
-at baseline and one month after the second vaccination
Safety Endpoints:
-7 days (including the day of vaccination) after Visits 1 and 2.
-the entire study period.

Endpoint Primario:
- a livello basale ed a un mese dalla seconda vaccinazione
Endpoin di Sicurezza
- 7 giorno (incluso il giorno della vaccinazione) dopo ogni visita (V1 e V2)
- per l'intera durata dello studio

E.5.2

Secondary end point(s)

Not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

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

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

Healthy subjects arm

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Italy

Spain

Russian Federation

United Kingdom

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

The end of study is defined as reported in the study protocol.

La definizione di 'fine dello studio' è riportata nella sezione 11 del Protocollo. Si definisce 'fine studio' ,quando tutti i test serologici saranno completati.

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

Number of subjects for this age range:

150

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:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

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

100

F.4.2.2

In the whole clinical trial

150

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)

not applicable

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

2014-02-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-10-22

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IMP with orphan designation in the indication
Orphan Designation Number:
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