Clinical Trials Register

Summary
EudraCT Number:	2021-001367-24
Sponsor's Protocol Code Number:	217043
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Temporarily Halted
Date on which this record was first entered in the EudraCT database:	2021-07-20
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-001367-24

A.3

Full title of the trial

A Phase II, randomized, partially blinded study to assess the safety, tolerability and immunogenicity of meningococcal combined ABCWY vaccine when administered to healthy infants.

Estudio Fase II, aleatorizado y parcialmente ciego, para evaluar la seguridad, reactogenicidad e inmunogenicidad de la vacuna antimeningocócica combinada ABCWY tras su administración a lactantes sanos.

A.3.1

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

A study on the safety, tolerability and immune response of meningococcal combined ABCWY vaccine in healthy infants.

Estudio de seguridad, reactogenicidad e inmunogenicidad de la vacuna antimeningocócica combinada ABCWY en lactantes sanos

A.4.1

Sponsor's protocol code number

217043

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 SA
B.1.3.4	Country	Spain
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 SA
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 S.A.
B.5.2	Functional name of contact point	CENTRO DE INFORMACIÓN
B.5.3	Address:
B.5.3.1	Street Address	c/ Severo Ochoa, 2
B.5.3.2	Town/ city	TRES CANTOS (MADRID)
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	34902202700
B.5.5	Fax number	3491 8070479
B.5.6	E-mail	es-ci@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	Combined Meningococcal Groups A, B, C, W and Y vaccine
D.3.2	Product code	MenACWY-7B
D.3.4	Pharmaceutical form	Powder and suspension for 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	-
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	GSKVx000000017986
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	Recombinant Neisseria meningitidis group B NHBA fusion protein
D.3.9.2	Current sponsor code	NHBA fusion protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NadA protein
D.3.9.2	Current sponsor code	NadA protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B fHbp fusion protein
D.3.9.2	Current sponsor code	fHbp fusion protein
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.3.8	INN - Proposed INN	Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Meningococcal group A oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
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.3.8	INN - Proposed INN	Meningococcal group C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.9.2	Current sponsor code	MenC-CRM197 conjugate
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.3.8	INN - Proposed INN	Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
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.3.8	INN - Proposed INN	Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
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	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	Yes
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.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	Combined Meningococcal Groups A, B, C, W and Y vaccine
D.3.2	Product code	MenACWY-7B
D.3.4	Pharmaceutical form	Powder and suspension for 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	-
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	GSKVx000000017986
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	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NHBA fusion protein
D.3.9.2	Current sponsor code	NHBA fusion protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NadA protein
D.3.9.2	Current sponsor code	NadA protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B fHbp fusion protein
D.3.9.2	Current sponsor code	fHbp fusion protein
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.3.8	INN - Proposed INN	Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Meningococcal group A oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.9.2	Current sponsor code	SUB31082
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.3.8	INN - Proposed INN	Meningococcal group C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.9.2	Current sponsor code	MenC-CRM197 conjugate
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.3.8	INN - Proposed INN	Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
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.3.8	INN - Proposed INN	Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.9.2	Current sponsor code	SUB126362
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	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	Yes
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	Combined Meningococcal Groups A, B, C, W and Y vaccine
D.3.2	Product code	MenABCWY
D.3.4	Pharmaceutical form	Powder and suspension for 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	Recombinant Neisseria meningitidis group B NHBA fusion protein
D.3.9.2	Current sponsor code	NHBA fusion protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NadA protein
D.3.9.2	Current sponsor code	NadA protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B fHbp fusion protein
D.3.9.2	Current sponsor code	fHbp fusion protein
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.3.8	INN - Proposed INN	Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Meningococcal group A oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
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.3.8	INN - Proposed INN	Meningococcal group C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.9.2	Current sponsor code	MenC-CRM197 conjugate
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.3.8	INN - Proposed INN	Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
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.3.8	INN - Proposed INN	Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
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	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	Yes
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.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	Bexsero - Meningococcal group B vaccine (rDNA, component, adsorbed)
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	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	Bexsero
D.3.4	Pharmaceutical form	Suspension for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NHBA fusion protein
D.3.9.2	Current sponsor code	NHBA fusion protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NadA protein
D.3.9.2	Current sponsor code	NadA protein
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.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B fHbp fusion protein
D.3.9.2	Current sponsor code	fHbp fusion protein
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.3.8	INN - Proposed INN	Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1
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	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	Yes
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.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 Europe MA EEIG
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 serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
D.3.2	Product code	J07AH08
D.3.4	Pharmaceutical form	Powder and solution for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein
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.3.8	INN - Proposed INN	Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
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.3.8	INN - Proposed INN	Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
D.3.9.2	Current sponsor code	MenW-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.3.8	INN - Proposed INN	Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
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	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	Yes
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

Healthy volunteers (Active immunization against IMD caused by Neisseria Meningitidis (N.meningitidis) serogroups A, B, C, W and Y)

Voluntarios sanos( inmunización activa frente la enfermedad meningocócica invasiva (EMI) causada por 5 serogrupos de Neisseria Meningitidis (N.meningitidis): A, B, C, W e Y

E.1.1.1

Medical condition in easily understood language

Meningitis, Invasive meningococcal disease

Meningitis, enfermedad meningocócica invasiva

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	10027249
E.1.2	Term	Meningitis meningococcal
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 2 formulations of MenABCWY-2Gen vaccine, the MenABCWY-1Gen vaccine, the MenB vaccine and the MenACWY-TT vaccine.
• To assess the immune response to the 2 formulations of MenABCWY-2Gen vaccine, to the MenABCWY-1Gen vaccine and to the MenB vaccine against all serogroup B indicator strains.
• To assess the immune response to the 2 formulations of MenABCWY-2Gen vaccine, to the MenABCWY-1Gen vaccine and to the MenACWY-TT vaccine against serogroups A, C, W and Y.

• Evaluar la seguridad y la reactogenicidad de la vacuna MenACWY-7B (50 μg y 100 μg), la vacuna MenABCWY, la vacuna MenB y la vacuna MenACWY-TT.
• Evaluar la respuesta inmunitaria a la vacuna MenACWY-7B (50 μg y 100 μg), la vacuna MenABCWY y la vacuna MenB frente a todas las cepas indicadoras del serogrupo B*.
• Evaluar la respuesta inmunitaria a la vacuna MenACWY-7B (50 μg y 100 μg), la vacuna MenABCWY y la vacuna MenB frente a todas las cepas indicadoras del serogrupo B*.

E.2.2

Secondary objectives of the trial

Not applicable

No aplicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Participants’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
• Healthy participants as established by medical history and clinical examination before entering into the study.
• A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
• Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.

• Progenitores/representantes legales de los sujetos que, en opinión del investigador puedan y vayan a cumplir los requisitos del protocolo.
• Consentimiento informado firmado o suscrito ante testigos/firmado con la huella digital de los padres/RLA del participante antes de realizar ningún procedimiento específico.
• Participantes sanos, según lo establecido en la historia clínica y exploración física previas a la entrada en el estudio.
• Lactantes de ambos sexos con edades comprendidas entre 55 y 89 días, ambas inclusive, (aprox. 2 ME) en el momento de la primera vacunación del estudio.
• Lactantes nacidos tras una gestación de ≥37 semanas, con un peso al nacer ≥2,5 kg.

E.4

Principal exclusion criteria

Medical conditions
• Current or previous, confirmed or suspected disease caused by N. meningitidis.
• Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth.
• Progressive, unstable or uncontrolled clinical conditions.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures.
• Congenital or peripartum disorders resulting in a chronic condition
• Major congenital defects, as assessed by the investigator.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
• Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
• Abnormal function or modification of the immune system resulting from:
- Autoimmune disorders or immunodeficiency syndromes.
- Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
- Administration of antineoplastic and immunomodulating agents or radiotherapy from birth.
- Administration of long-acting immune-modifying drugs at any time during the study period.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy
• Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period.
• Previous vaccination with any meningococcal vaccine.
• Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.

Prior/Concurrent clinical study experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).

Other exclusions
• Child in care.
• Study personnel as an immediate family or household member.
• For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.

• Enfermedad confirmada o sospechada por N. meningitidis actual o previa.
• Contacto domiciliario y/o exposición cercana a una persona con infección por N. meningitidis (confirmada en el laboratorio) desde el nacimiento.
• Trastornos clínicos progresivos, inestables o no controlados.
• Trastornos clínicos que supongan una contraindicación para la vacunación intramuscular y la extracción de sangre.
• Cualquier trastorno neuroinflamatorio, enfermedades neurológicas congénitas y periparto, encefalopatías, crisis epilépticas .
• Trastornos congénitos o periparto que ocasionen una afección crónica
• Defectos congénitos importantes, a criterio del el investigador.
• Antecedentes de reacción o de hipersensibilidad posiblemente exacerbada por algún componente de la(s) vacuna(s).
• Hipersensibilidad, incluida la alergia, a cualquier componente de las vacunas, incluido el toxoide diftérico (CRM197) o a los medicamentos o material médico, incluido el látex, cuyo uso esté previsto en este estudio.
• Disfunción o modificación del sistema inmunitario secundarias a lo siguiente:
− Trastornos autoinmunes (entre otros, trastornos autoinmunes hematológicos, endocrinológicos, hepáticos, musculares, nerviosos o cutáneos; lupus eritematoso y trastornos asociados; artritis reumatoide y trastornos asociados; esclerodermia y trastornos asociados) o síndromes de inmunodeficiencia (entre otros, síndromes de inmunodeficiencia adquirida y síndromes de inmunodeficiencia primaria).
− Administración sistémica de corticosteroides (v.o./i.v./i.m.) durante más de 14 días consecutivos desde el nacimiento hasta la visita 5. Esta se corresponde con un equivalente de prednisona de ≥0,5 mg/kg/día (con un máximo de 20 mg/día). Se permite el uso inhalado y tópico de esteroides.
− Administración de antineoplásicos e inmunomoduladores o radioterapia desde el nacimiento.
− Administración de inmunomoduladores de acción prolongada en cualquier momento durante el período de estudio (p. ej., infliximab).
• Cualquier otro estado clínico que, en opinión del investigador, pudiera suponer un riesgo para el participante como consecuencia de su participación en el estudio.

Tratamiento previo/concomitante
• Uso de un producto (medicamento, vacuna o dispositivo médico) en investigación o no registrado, distinto de las vacunas del estudio desde el nacimiento o previsión de su uso durante el periodo de estudio.
• Vacunación previa con cualquier vacuna meningocócica.
• Administración de inmunoglobulinas y/o cualquier hemoderivado o derivado del plasma desde el nacimiento o administración prevista durante el período de estudio hasta la visita 5.
• Administración crónica (definida por una duración mayor de 14 días en total) de inmunosupresores o de otros inmunomoduladores desde el nacimiento hasta la visita 5. En el caso de los corticoides, esta se corresponde con un equivalente de prednisona de ≥0,5 mg/kg/día (con un máximo de 20 mg/día). Se permite el uso inhalado y tópico de esteroides.

Experiencia previa y actual en ensayos clínicos
Participación simultánea en otro ensayo clínico, en el que la participante se haya expuesto o se puede exponer a una vacuna/producto (medicamento o producto sanitario) en investigación o de naturaleza no experimental en cualquier momento del período de estudio.

Otras exclusiones
• Niños en situación de acogida
• Personal del estudio (familiares inmediatos o miembros de la unidad familiar).
• En cuanto a las contraindicaciones de la administración de las vacunas sistemáticas previstas en el estudio , consulte las fichas técnicas/prospectos autorizados de los productos.

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of participants with solicited administration site events
2. Percentage of participants with solicited systemic events
3. Percentage of participants with any unsolicited adverse events (AEs), including all medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal, and adverse events of special interest (AESIs)
4. Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs
5. Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each serogroup B indicator strain
6. Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
7. Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
8. hSBA geometric mean titers (GMTs) for each serogroup B indicator strain
9. hSBA GMTs for each serogroup B indicator strain
10. hSBA GMTs for each serogroup B indicator strain
11. Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain
12. Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
13. Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
14. Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
15. hSBA GMTs for each A, C, W and Y serogroup
16. hSBA GMTs for each A, C, W and Y serogroup
17. hSBA GMTs for each A, C, W and Y serogroup
18. Within group hSBA GMRs for each A, C, W and Y serogroup

1. Porcentaje de participantes con eventos solicitados en el sitio de administración
2. Porcentaje de participantes con eventos sistémicos solicitados
3. Porcentaje de participantes con cualquier evento adverso no solicitado (AEs), incluyendo todos los eventos adversos atendidos médicamente (MAEs), eventos adversos graves (SAEs), AEs que conllevan a la retirada, y eventos adversos de interés especial (AESIs)
4. Porcentaje de participantes con MAEs, SAEs, AEs que conllevan a la retirada, y AESIs
5. Porcentaje de participantes con títulos de actividad bactericida en suero humano (hSBA) ≥ límite inferior de cuantificación (LIC) para cada cepa indicadora del serogrupo B
6. Porcentaje de participantes con títulos de actividad bactericida en suero humano (hSBA) ≥ límite inferior de cuantificación (LIC) para cada cepa indicadora del serogrupo B
7. Porcentaje de participantes con títulos de actividad bactericida en suero humano (hSBA) ≥ límite inferior de cuantificación (LIC) para cada cepa indicadora del serogrupo B
8. Títulos medios geométricos (GMT) hSBA para cada cepa indicadora del serogrupo B
9. Títulos medios geométricos (GMT) hSBA para cada cepa indicadora del serogrupo B
10. Títulos medios geométricos (GMT) hSBA para cada cepa indicadora del serogrupo B
11. Razones entre medias geométricas (GMR) de hSBA para cada cepa indicadora del serogrupo B.
12 Porcentaje de participantes con títulos hSBA ≥ LIC para cada serogrupo A, C, W e Y
13. Porcentaje de participantes con títulos hSBA ≥ LIC para cada serogrupo A, C, W e Y
14. Porcentaje de participantes con títulos hSBA ≥ LIC para cada serogrupo A, C, W e Y
15. GMT de hSBA para cada serogrupo A, C, W e Y 
16. GMT de hSBA para cada serogrupo A, C, W e Y
17. GMT de hSBA para cada serogrupo A, C, W e Y
18. • GMR de hSBA para cada serogrupo A, C, W e Y

E.5.1.1

Timepoint(s) of evaluation of this end point

1, 2. During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
3. During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
4. During the study period (Day 1 through Day 481)
5, 8, 12, 15. At 1 month after the second vaccination (Day 91)
6, 9, 13, 16. At pre-third vaccination (Day 301)
7, 10, 14, 17. At 1 month after the third vaccination (Day 331)
11, 18. At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)

1, 2. Durante los 7 días (incluido el día de la vacunación) después de cada vacunación (vacunas administradas los días 1 y 61 y el día 301)
3. Durante los 30 días (incluido el día de la vacunación) después de cada vacunación (vacunas administradas los días 1 y 61 y el día 301)
4. Durante el período de estudio (desde el día 1 hasta el día 481)
5, 8, 12, 15. 1 mes después de la segunda vacunación (día 91)
6, 9, 13, 16. Antes de la tercera vacunación (día 301)
7, 10, 14, 17. 1 mes después de la tercera vacunación (día 331)
11, 18. 1 mes después de la tercera vacunación (día 331) en comparación con antes de la tercera vacunación (día 301)

E.5.2

Secondary end point(s)

Not applicable

No aplicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

No aplicable

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability
Immunogenicity

Tolerabilidad
Inmunogenicidad

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Part I - abierta; Part II - observado ciego para los brazos de la parte 2 MenABCWY-2Gen y MenABCWY-

Part I - Open; Part II - Observer-blind manner for the 2 MenABCWY-2Gen and MenABCWY-1Gen arms

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

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

South Africa

Finland

Germany

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

End of Study (EoS): Date of the last testing/reading released of the Human Biological Samples or imaging data, related to primary endpoints. EoS must be achieved no later than 8 months after Last Subject Last Visit (LSLV).

Fin del estudio (EoS): Fecha de la última prueba/lectura publicada de las Muestras Biológicas Humanas o los datos de imágenes, relacionados con los criterios de valoración primarios. El fin del estudio debe lograrse no más tarde de los 8 meses después de la última visita al sujeto.

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:

688

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:

688

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Participants under age incapable of giving consent personally.

Participantes menores de edad incapaces de dar su consentimiento personalmente.

F.4 Planned number of subjects to be included

F.4.1

In the member state

160

F.4.2

For a multinational trial

F.4.2.1

In the EEA

470

F.4.2.2

In the whole clinical trial

688

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)

There is no plan for treatment as participants are healthy.

No hay ningún plan de tratamiento, ya que los participantes están sanos.

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

2021-11-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-29

P. End of Trial
P.	End of Trial Status	Temporarily Halted

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