Clinical Trials Register

Summary
EudraCT Number:	2018-000431-27
Sponsor's Protocol Code Number:	204894
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:	2021-01-05
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

2018-000431-27

A.3

Full title of the trial

A Phase 1/2, randomized, observer-blind, controlled, multi-center study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A), when administered intramuscularly as a single dose or as two doses according to a 0, 1-month schedule to infants aged 6 and 7 months.

Studio clinico multicentrico di Fase I/II, randomizzato e controllato, con osservatore in cieco, volto a valutare la sicurezza, la reattogenicità e l’immunogenicità del vaccino sperimentale (GSK3389245A) di GlaxoSmithKline Biologicals diretto contro il virus respiratorio sinciziale (RSV) e basato sulle proteine virali F, N e M2-1 codificate dall’adeno-vettore ChAd155-RSV, quando somministrato con una singola dose o con due dosi per via intramuscolare, secondo una schedula a 0, 1-mesi, a bambini di 6 e 7 mesi d’età.

A.3.1

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

Respiratory syncytial virus (RSV) investigational vaccine in infants aged 6 and 7 months likely to be unexposed to RSV.

Vaccino sperimentale diretto contro il virus respiratorio sinciziale (RSV) somministrato in bambini di 6 e 7 mesi d’età probabilmente non esposti precedentemente al virus RSV.

A.3.2

Name or abbreviated title of the trial where available

RSV PED-011

A.4.1

Sponsor's protocol code number

204894

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	GLAXOSMITHKLINE BIOLOGICALS
B.1.3.4	Country	Belgium
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	GlaxoSmithKline Biologicals
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Biologicals
B.5.2	Functional name of contact point	Clinical Disclosure Advisor
B.5.3	Address:
B.5.3.1	Street Address	Rue de l'Institut, 89
B.5.3.2	Town/ city	Rixensart
B.5.3.3	Post code	1330
B.5.3.4	Country	Belgium
B.5.4	Telephone number	442089904466
B.5.5	Fax number	00000000
B.5.6	E-mail	GSKClinicalSupportHD@gsk.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	ChAd155-RSV (high dose, 50000000000 vp)
D.3.2	Product code	[ChAd155-RSV (high dose, 50000000000 vp))]
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ChAd155-RSV
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Yes
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	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	ChAd155-RSV (low dose, 15000000000 vp)
D.3.2	Product code	[ChAd155-RSV (low dose, 15000000000 vp)]
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ChAd155-RSV
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Yes
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	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	Bexsero
D.2.1.1.2	Name of the Marketing Authorisation holder	GSK vaccine S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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 contro il meningococco di gruppo B
D.3.2	Product code	[Vaccino contro il meningococco di gruppo B]
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.3.9.2	Current sponsor code	NHBA
D.3.9.4	EV Substance Code	SUB96088
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.3.9.2	Current sponsor code	NadA
D.3.9.4	EV Substance Code	SUB96089
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.3.9.2	Current sponsor code	fHbp
D.3.9.4	EV Substance Code	SUB96090
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.3.9.2	Current sponsor code	OMV
D.3.9.4	EV Substance Code	SUB96091
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	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	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	Menveo
D.2.1.1.2	Name of the Marketing Authorisation holder	GSK Vaccines S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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 meningococcico coniugato del gruppo A, C, W135 e Y
D.3.2	Product code	[Vaccino meningococcico coniugato del gruppo A, C,
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.3.9.2	Current sponsor code	MenA-CRM197 conjugate
D.3.9.4	EV Substance Code	SUB31082
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MenC-CRM197
D.3.9.4	EV Substance Code	SUB26743
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.3.9.2	Current sponsor code	MenW-CRM197 conjugate
D.3.9.4	EV Substance Code	SUB31083
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.3.9.2	Current sponsor code	MenY-CRM197 conjugate
D.3.9.4	EV Substance Code	SUB126362
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.3.11 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: 5
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	Italy
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 meningococcico gruppo A, C, W-135 e Y
D.3.2	Product code	[Vaccino coniugato meningococcico gruppo A, C, W-1
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.3.9.2	Current sponsor code	MenA-TT
D.3.9.4	EV Substance Code	SUB36479
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.3.9.2	Current sponsor code	MenC-TT
D.3.9.4	EV Substance Code	SUB26116
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.3.9.2	Current sponsor code	MenW-135-TT
D.3.9.4	EV Substance Code	SUB36481
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.3.9.2	Current sponsor code	MenY-TT
D.3.9.4	EV Substance Code	SUB36482
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.3.11 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: 6
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	Synflorix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals S.A
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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 pneumococcico polisaccaridico coniugato (adsorbito)
D.3.2	Product code	[Vaccino pneumococcico polisaccaridico coniugato (
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.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38400
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38432
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.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38414
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.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38420
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38432
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38449
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38459
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38342
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38402
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB38409
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.3.11 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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Active immunization of infants for the prevention of any lower respiratory tract infections (LRTI; bronchiolitis and [broncho] pneumonia) associated with respiratory syncytial virus (RSV).

Immunizzazione attiva dei bambini per prevenire le infezioni del tratto respiratorio inferiore (LRTI =Lower Respiratory Tract Infections; bronchiolite e (bronco)polmonite) associate al virus respiratorio sinciziale (RSV).

E.1.1.1

Medical condition in easily understood language

Respiratory tract infection caused by respiratory syncytial virus (RSV)

Infezione del tratto respiratorio causata dal virus respiratorio sinciziale (RSV).

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10035692
E.1.2	Term	Pneumonia due to respiratory syncytial virus
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061603
E.1.2	Term	Respiratory syncytial virus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10038718
E.1.2	Term	Respiratory syncytial virus bronchiolitis
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 evaluate the safety and reactogenicity of the RSV investigational vaccine when administered intramuscularly (IM) as one (1.5x10^10
viral particles [vp]) dose or as two (5x10^10 vp) doses according to a 0, 1-month schedule, up to 60 days after Dose 1 (i.e., Day 61) in infants
aged 6 and 7 months.

Valutare la sicurezza e la reattogenicità del vaccino sperimentale anti-RSV somministrato per via intramuscolare in dose singola (1,5 x 1010 vp) o in due dosi (5 x 1010 vp) secondo una schedula a 0, 1-mesi, fino a 60 giorni dopo la Dose 1 (Giorno 61), in bambini di 6 e 7 mesi d’età.

E.2.2

Secondary objectives of the trial

¿ To evaluate RSV respiratory tract infections of any severity from Visit 1 through end of first RSV transmission season, in infants (6 and 7
months);
¿ To evaluate the safety of the RSV investigational vaccine administered IM as 1 (1.5x10^10 vp) or 2 (5x10^10 vp) doses by a 0, 1-
month schedule from study start to the end of the second RSV transmission season in infants (6 and 7 months);
¿ To evaluate RSV respiratory tract infections from Visit 1 to the end of the second RSV transmission season, in infants (6 and 7 months);
¿ To evaluate very severe RSV-LRTI from Visit 1 to the end of the first RSV transmission season in RSV infected infants (6 and 7 months) with negative RSV exposure status;
¿ To evaluate humoral immunogenicity induced by the RSV investigational vaccine administered IM as 1 (1.5x10^10 vp) or 2 (5x10^10 vp) doses by a 0, 1-month schedule, from study start to the end of the first RSV transmission season in infants (6 and 7 months).

Valutare:
-la comparsa di infezioni RSV al tratto respiratorio a partire dalla V1 fino alla fine della prima stagione di trasmissibilità dell’RSV
-la sicurezza del vaccino sperimentale anti-RSV somministrato per via intramuscolare in dose singola o in due dosi secondo una schedula a 0, 1-mesi, dall’inizio dello studio fino alla fine della seconda stagione di trasmissibilità dell’RSV
-la comparsa di infezioni RSV al tratto respiratorio dalla V1 fino alla fine della seconda stagione di trasmissibilità dell’RSV
-la comparsa di infezioni RSV-LRTI molto gravi, dalla V1 fino alla fine della prima stagione di trasmissibilità dell’RSV in bambini con sierostato RSV-negativo alla visita di screening
-l’immunogenicità umorale indotta dal vaccino sperimentale anti-RSV somministrato per via intramuscolare in dose singola o in due dosi secondo una schedula a 0,1-mesi, dall’inizio dello studio fino alla fine della prima stagione di trasmissibilità dell’RSV

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subjects' parent(s)/Legally Acceptable Representative [LAR(s)] who, in the opinion of the investigator, can and will comply with the
requirements of the protocol
- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- A male or female between and including 6 and 7 months of age (from the day the infant becomes 6 months of age until the day before the
infant achieves 8 months of age) at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born full-term with a minimum birth weight of 2.5 kg.
- Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer.

- I genitori/i legali rappresentanti del soggetto devono essere ritenuti dallo Sperimentatore capaci e desiderosi di osservare quanto richiesto dal protocollo di studio (per esempio: completare le schede diario, ritornare per le visite di follow-up).
- Si deve ottenere il consenso informato scritto dai genitori/tutori legali del soggetto prima di eseguire qualsiasi procedura dello studio.
- Soggetto di sesso femminile o maschile, d’età compresa tra i 6 e i 7 mesi (cioè dal giorno in cui il soggetto compie 6 mesi d’età fino al giorno prima del compimento dell’8° mese) al momento della prima vaccinazione.
- Soggetto sano come stabilito dalla storia medica e dalla visita clinica prima dell’entrata nello studio.
- Soggetto nato a termine, cioè dopo una gestazione di 37-42 settimane, con un peso minimo alla nascita di 2,5 kg.
- I genitori/i tutori legali del soggetto devono possedere un computer o un telefono (fisso o mobile) per essere contattati.

E.4

Principal exclusion criteria

- Child in care
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
- Chronic administration of immunosuppressants or other immunemodifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day (for pediatric subjects), or equivalent. Topical steroids are allowed.
- Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
- Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of scheduled routine pediatric vaccines. Scheduled routine pediatric vaccines may be administered = 7 days before a dose of study vaccine or = 7 days following a dose of study vaccine, with the exception of live viral vaccines which may be administered = 14 days before a dose or = 7 days after a dose.
- Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical
examination or laboratory screening tests.
- A history of, or on-going confirmed RSV disease or highly compatible clinical picture.
- Serious chronic illness.
- Major congenital defects.
- •History of any neurological disorders or seizures.
- History of or current autoimmune disease.
- History of recurrent wheezing.
- History of chronic cough.
- Previous hospitalization for lower respiratory illnesses.
- Previous, current or planned administration of Synagis (palivizumab).
- Neurological complications following any prior vaccination.
- Born to a mother known or suspected to be Human Immmunodeficiency Virus (HIV)-positive.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
- Family history of congenital or hereditary immunodeficiency.
- Previous vaccination with a recombinant simian or human adenoviral vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Current severe eczema.
- Acute disease and/or fever at the time of enrolment (Visit 1).
- Any clinically significant Grade 1 or any =Grade 2 hematological or biochemical laboratory abnormality detected at the last screening blood sampling.
- Any medical condition that in the judgment of the investigator would make IM injection unsafe.
- Any other conditions that the investigator judges may interfere with study procedures, findings.
- Any conditions that could constitute a risk for the subjects while participating to this study.
- Weight below the fifth percentile of the local weight-for-age curve.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject or mother has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Planned move to a location that will prohibit participating in the trial until study end.

- Bambino sotto assistenza
- Utilizzo di qualsiasi farmaco o vaccino sperimentale o non registrato, escluso il presente vaccino in studio, nei 30 giorni antecedenti la prima dose del vaccino in studio (dal Giorno -29 al Giorno 1) o programmazione del loro uso durante lo studio clinico.
- Somministrazione cronica (definita come più di 14 giorni in totale) di farmaci immunosoppressori o immunomodulatori nei sei mesi precedenti la prima vaccinazione. Per i corticosteroidi s’intenda il prednisone (= 0,5 mg/kg/die) o equivalente. Gli steroidi topici sono consentiti.
- Somministrazione di farmaci immuno-modulatori a lunga azione (es. infliximab) o programmazione del loro uso in qualsiasi momento dello studio.
-Somministrazione di immunoglobuline e/o di derivati ematici nei tre mesi precedenti la prima vaccinazione, o programmazione del loro uso durante lo studio.
- Pianificazione/somministrazione di un vaccino non previsto dal protocollo di studio da 30 giorni prima della prima vaccinazione fino a 30 giorni dopo la somministrazione dell’ultima dose del vaccino in studio, ad eccezione dei vaccini pediatrici di routine che possono essere somministrati da almeno 7 giorni prima di una dose del vaccino in studio, o a partire da almeno 7 giorni dopo, ad eccezione dei vaccini contenenti virus vivi che potranno essere somministrati da almeno 14 giorni prima di una dose del vaccino in studio, o a partire da almeno 14 giorni dopo.
- Disfunzione acuta o cronica, clinicamente significativa, polmonare, cardiovascolare, epatica o renale, determinata da esame fisico o da test di laboratorio.
- Storia di malattia da RSV o malattia da RSV in corso, confermata, o presenza di un quadro clinico fortemente compatibile (es. bronchiolite)
- Grave malattia cronica.
- Difetto congenito maggiore.
- Storia di un qualsiasi disordine neurologico o di convulsioni.
- Storia di malattia autoimmune o malattia autoimmune in corso.
- Storia di sibilo respiratorio (“wheezing”) ricorrente, definito come due o più episodi di “wheezing” negli ultimi 12 mesi (verificati dal medico tramite auscultazione).
- Storia di tosse cronica (di durata uguale o superiore alle 4 settimane).
- Precedente ospedalizzazione per malattie alle basse vie respiratorie.
- Somministrazione precedente, in corso o programmata di Synagis (palivizumab).
- Complicazioni neurologiche successive a qualsiasi vaccinazione precedente.
- Soggetto nato da madre nota o sospettata per essere HIV-positiva (non è richiesto il test di laboratorio).
- Qualsiasi condizione sospetta o confermata di immunosoppressione o immunodeficienza, in base alla storia medica e all’esame fisico .
- Storia familiare di immunodeficienza congenita o ereditaria.
- Vaccinazione precedente con un vaccino contenente un vettore adenovirale umano o da scimmia.
- Storia di una qualsiasi reazione o ipersensibilità che potrebbe essere aggravata da un qualsiasi componente del vaccino.
- Ipersensibilità al lattice.
- Eczema severo in corso.
- Malattia acuta e/o febbre al momento dell’arruolamento (VISITA 1)
- Ogni anomalia di laboratorio ematologica o biochimica clinicamente significativa di Grado 1* o qualsiasi di Grado = 2*, rilevata all’ultimo prelievo di sangue di screening.
- Qualsiasi altra condizione che il Medico Sperimentatore giudichi che possa interferire con le procedure dello studio o con i risultati.
- Qualsiasi condizione che possa costituire un rischio per il soggetto durante la partecipazione allo studio.
- Peso sotto il 5° percentile della curva locale peso/età.
- Contemporanea partecipazione ad un altro studio clinico, in qualsiasi momento durante il presente studio, in cui il soggetto, o la madre, sia stato o sarà esposto ad un farmaco o vaccino sperimentale o no, sia esso un prodotto farmaceutico o un dispositivo.
- Trasferimento programmato in località che non permetterebbe la partecipazione a questo studio fino alla sua conclusione.

E.5 End points

E.5.1

Primary end point(s)

- Occurrence of each solicited local and general AE
- Occurrence of any unsolicited AE
- Occurrence of any serious adverse event (SAE)
- Occurrence of episode of spontaneous or excessive bleeding (AE of special interest)

- Comparsa di qualsiasi AE sollecitato, locale e generale
- Comparsa di qualsiasi AE non sollecitato
- Comparsa di qualsiasi SAE (Serious Adverse Event = Evento Avverso Grave)
- Comparsa di episodi di sanguinamento spontaneo o eccessivo (AE d’interesse specifico)

E.5.1.1

Timepoint(s) of evaluation of this end point

- During a 7-day follow-up period after each vaccination (i.e., the day of vaccination and 6 subsequent days)
- During a 30-day follow-up period after each vaccination (i.e., the day of vaccination and 29 subsequent days)
- From Day 1 up to Day 61
- During a 30-day follow-up period after each vaccination (i.e., the day of vaccination and 29 subsequent days)

- Durante il periodo di 7 giorni successivo ad ogni vaccinazione (s’intende il giorno della vaccinazione e i 6 giorni seguenti)
- Nel periodo di 30 giorni successivo ad ogni vaccinazione (s’intende il giorno della vaccinazione e i 29 giorni seguenti)
- Dal Giorno 1 al Giorno 61
- Nei 30 giorni di osservazione dopo ogni vaccinazione

E.5.2

Secondary end point(s)

Occurrence of RSV-RTI, RSV-LRTI, severe RSV-LRTI and very severe RSV-LRTI (according to standardized case
definitions); Occurrence of RSV-RTI, RSV-LRTI, severe RSV-LRTI and very severe RSV-LRTI (according to standardized case
definitions); Occurrence of SAEs; Occurrence of RSV-LRTI (AE of special interest); Occurrence of very severe RSV-LRTI (according to standardized case definitions) among RSV infected infants
with a negative RSV exposure status (at screening based on in-stream baseline serological testing); Humoral response to the investigational RSV vaccine:
- Neutralizing antibody titers against RSV-A.
- RSV F antibody concentrations.

Comparsa di RSV-RTI, RSV-LRTI e di RSV-LRTI gravi e molto gravi (secondo la definizione standardizzata dei casi); Comparsa di RSV-RTI, RSV-LRTI e di RSV-LRTI gravi e molto gravi (secondo la definizione standardizzata dei casi); Comparsa di SAE; Comparsa di RSV-LRTI (AE d’interesse specifico); Comparsa di RSV-LRTI molto gravi (secondo le definizioni standardizzate dei casi) nei bambini con sierostato RSV-negativo alla visita di screening; Risposta immunitaria umorale al vaccino sperimentale anti-RSV:
- Titoli degli anticorpi neutralizzanti diretti contro RSV-A
- Concentrazioni degli anticorpi anti-F dell’RSV

E.5.2.1

Timepoint(s) of evaluation of this end point

From first vaccination (Day 1) up to the end of the first RSV transmission season; From first vaccination (Day 1) up to the end of the second RSV transmission season; From first vaccination (Day 1) up to the end of the second RSV transmission season; From first vaccination (Day 1) up to the end of the first RSV transmission season, and up to the end of the second RSV
transmission season; From first vaccination (Day 1) up to the end of the first RSV transmission season; Prevaccination (Screening), post-Dose 1 (Day 31) and post-Dose 2 (Day 61 and at the end of the first RSV transmission
season)

Dalla somministrazione della prima vaccinazione (Giorno 1) fino alla fine della prima stagione di trasmissibilità dell’RSV; Dalla somministrazione della prima vaccinazione (Giorno 1) fino alla fine della seconda stagione di trasmissibilità dell’RSV; Dalla somministrazione della prima vaccinazione (Giorno 1) fino alla fine della seconda stagione di trasmissibilità dell’RSV; Dalla somministrazione della prima vaccinazione (Giorno 1) fino alla fine della prima e della seconda stagione di trasmissibilità dell’RSV; Dalla prima vaccinazione (Giorno 1) fino alla fine della prima stagione di trasmissibilità dell’RSV; Pre-vaccinazione (Screening), post-Dose 1 (Giorno 31) e post-Dose 2 (Giorno 61 e alla fine della prima stagione di trasmissibilità dell’RSV)

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

Immunogenicità

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

First administration in age group (6-7 month old infants)

Prima somministrazione in gruppo di età (bambini di 6-7 mesi)

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

E.8.1.7.1

Other trial design description

Con osservatore in cieco

Observer blind

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Nimenrix unico comparatore per l'Italia. Il placebo in Italia viene usato solo per mantenere il ciec

Nimenrix only comparator for Italy. The placebo in Italy is used only for mantain the blindness.

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

Argentina

Australia

Brazil

Canada

Colombia

Hong Kong

Mexico

Panama

South Africa

Thailand

Turkey

United States

Belgium

Finland

Italy

Poland

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last testing results released of samples collected at Visit 8 (end of the second RSV transmission season) related to primary and secondary endpoints.

Quando saranno stati rilasciati gli ultimi risultati di laboratorio dei campioni raccolti alla Visita 8 (fine della seconda stagione di trasmissibilità dell’RSV) e relativi agli endpoints primari e secondari.

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

176

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

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

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

F.4.2.2

In the whole clinical trial

176

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

2019-02-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-15

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

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