Clinical Trials Register

Summary
EudraCT Number:	2009-016841-24
Sponsor's Protocol Code Number:	113369
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-03-15
Trial results	View results

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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-016841-24

A.3

Full title of the trial

Estudio de fase IIIB, abierto, multinacional, aleatorizado y controlado para demostrar la no inferioridad de la respuesta inmunitaria a la vacuna antimeningocócica (serogrupos A, C, W-135 e Y) conjugada (MenACWY-TT) de GSK Biologicals, administrada por vía intramuscular a los 2, 4 y 12 meses de edad o a los 2, 3, 4 y 12 meses de edad, en comparación con dos vacunas MenC conjugadas y autorizadas, administradas por vía intramuscular a los 2, 4 y 12 meses de edad.

A.3.2

Name or abbreviated title of the trial where available

MenACWY-TT-083

A.4.1

Sponsor's protocol code number

113369

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline S.A.
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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.3.2	Product code	MenACWY-TT
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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.3.9.3	Other descriptive name	Serotipo A del polisacárido de Neisseria meningitidis conjugada con toxoide tetánico
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.3.9.3	Other descriptive name	Serotipo C del polisacárido de Neisseria meningitidis conjugada con toxoide tetánico
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-TT
D.3.9.3	Other descriptive name	Serotipo W del polisacárido de Neisseria meningitidis conjugada con toxoide tetánico
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.3.9.3	Other descriptive name	Serotipo Y del polisacárido de Neisseria meningitidis conjugada con toxoide tetánico
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	MENJUGATE Kit polvo y disolvente para suspensión inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	ANTIGENO OLIGOSACARIDO MENINGOCOCO GRUPO C
D.3.9.3	Other descriptive name	ANTIGENO OLIGOSACARIDO MENINGOCOCO GRUPO C
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	CORYNEBACTERIUM DIPHTERIAE PROTEINA CRM 197
D.3.9.3	Other descriptive name	CORYNEBACTERIUM DIPHTERIAE PROTEINA CRM 197
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.3.11 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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	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	NEISVAC-C suspensión para inyección en jeringa precagada
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER HEALTHCARE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	ANTIGENO POLISACARIDO MENINGOCOCO GRUPO C
D.3.9.3	Other descriptive name	ANTIGENO POLISACARIDO MENINGOCOCO GRUPO C
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	TOXOIDE TETANICO
D.3.9.3	Other descriptive name	TETANUS TOXOID
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.3.11 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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	SYNFLORIX suspensión inyectable en jeringa precargada
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	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 1
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 1
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.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 14
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 14
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.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 18C
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 18C
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 19F
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 19F
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 23F
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 23F
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.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 4
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 4
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 5
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 5
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.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 6B
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 6B
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.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 7F
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 7F
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.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 9V
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 9V
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.3.11 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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	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	INFANRIX hexa. Polvo liofilizado y susp. para reconstituir en una susp. inyectable
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	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	ANTIGENO SUPERFICIE HEPATITIS B
D.3.9.3	Other descriptive name	ANTIGENO SUPERFICIE HEPATITIS B
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	BORDETELLA PERTUSSIS HEMAGLUTININA FILAMENTOSA
D.3.9.3	Other descriptive name	BORDETELLA PERTUSSIS HEMAGLUTININA FILAMENTOSA
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	BORDETELLA PERTUSSIS PROTEINA MEB EXTERNA 69KD
D.3.9.3	Other descriptive name	BORDETELLA PERTUSSIS PROTEINA MEB EXTERNA 69KD
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	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BORDETELLA PERTUSSIS TOXOIDE
D.3.9.3	Other descriptive name	BORDETELLA PERTUSSIS TOXOIDE
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	HAEMOPHILLUS INFLUENZAE TIPO B
D.3.9.3	Other descriptive name	HAEMOPHILLUS INFLUENZAE TIPO B
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	HINFLUENZAE TIPO B POLISACARIDO CONJUGADO TOXOIDE TETANICO
D.3.9.3	Other descriptive name	HINFLUENZAE TIPO B POLISACARIDO CONJUGADO TOXOIDE TETANICO
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TOXOIDE DIFTERICO
D.3.9.3	Other descriptive name	DIPHTHERIA TOXOID
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TOXOIDE TETANICO
D.3.9.3	Other descriptive name	TETANUS TOXOID
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VIRUS POLIO TIPO I
D.3.9.3	Other descriptive name	VIRUS POLIO TIPO I
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VIRUS POLIO TIPO II
D.3.9.3	Other descriptive name	VIRUS POLIO TIPO II
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VIRUS POLIO TIPO III
D.3.9.3	Other descriptive name	VIRUS POLIO TIPO III
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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

Inmunización activa de lactantes frente a los serogrupos A, C, W-135 e Y de Neisseria meningitidis durante el primer año de vida, seguida de una dosis de recuerdo administrada a los 12 meses de edad.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10062371
E.1.2	Term	Active immunization

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demostrar, a los 5 meses de edad:
1.la no inferioridad del esquema de 3 dosis de la vacuna MenACWY-TT conjugada en comparación con el esquema de 2 dosis de la vacuna MenC-CRM197 conjugada
2.la no inferioridad del esquema de 3 dosis de la vacuna MenACWY-TT conjugada, frente al esquema de 2 dosis de la vacuna MenC-TT conjugada
3.la no inferioridad del esquema de 2 dosis de la vacuna MenACWY-TT conjugada frente al esquema de 2 dosis de la vacuna MenC-CRM197 conjugada
4.la no inferioridad del esquema de 2 dosis de la vacuna MenACWY-TT conjugada, frente al esquema de 2 dosis de la vacuna MenC-TT conjugada

E.2.2

Secondary objectives of the trial

Evaluar la inmunogenicidad de:
1.los serogrupos A, C, W 135 e Y, en términos de rSBA en todos los sujetos (excepción: para el tiempo previo a la vacunación: subgrupo aleatorizado del 50% de los sujetos de los grupos de estudio; subgrupo aleatorizado del 50% de Men C y subgrupo aleatorizado del 25% de MenA, W 135 e Y en los grupos de control), de hSBA en un subgruo aleatorizado del 25% de los sujetos y de anti-PS en un subgrupo aleatorizado del 25% de los sujetos
2.Infanrix hexa, en términos de porcentaje de sujetos con cifras superiores a los valores clásicos de punto de corte excepto para anti-FHA, anti-PRN y anti-PT, en cuyo caso se calcularán los GMC en un subgrupo aleatorizado del 50% de los sujetos.
3.inmunogenicidad de Synflorix, en términos de porcentaje de sujetos con concentraciones de anticuerpos antineumocócicos (ELISA) por encima del punto de corte y GMC y con titulos de actividad opsonofagocítica 1:8 y GMT
4. Seguridad y reactogenicidad de la vacuna en investigación

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Sujetos cuyos padres/representantes legales aceptables (RLA) puedan y deseen , en opinión del investigador, cumplir los requisitos del protocolo (p. ej., cumplimentación de las tarjetas diarias, retorno a la visita de seguimiento).
•Niños o niñas de entre 6 y 12 semanas (42-90 días) de edad en el momento de la primera vacunación.
•Firma del consentimiento por los padres o tutores del sujeto.
•Ausencia de problemas claros de salud recogidos en la historia clínica y en la exploración física antes de empezar el estudio.
•Nacimiento tras un periodo mínimo de gestación de 36 semanas

E.4

Principal exclusion criteria

•Niño bajo custodia
•Uso de un producto (medicamento o vacuna) en investigación o no registrado, diferente de la(s) vacuna(s) del estudio, en los 30 días anteriores a la administración de la primera dosis de la vacuna del estudio o uso previsto durante el periodo de estudio.
•Administración prolongada (definida por un periodo superior a 14 días en total) de inmunosupresores u otros inmunomoduladores desde el nacimiento. En el caso de los corticoides, esto supone una dosis de prednisona >= 0,5 mg/kg/día, o equivalente. Se permitirán los esteroides por vía inhalatoria o tópica.
•Administración prevista/administración de una vacuna no fijada en el protocolo del estudio desde 30 días antes de la primera dosis de la(s) vacuna(s) del estudio hasta 30 días después de administrar la última dosis de las mismas (es decir, dosis de recuerdo), con excepción de la vacuna antirrotavírica que podrá administrarse en cualquier momento del estudio de acuerdo con las recomendaciones nacionales de vacunación. La vacuna MMR(V) se podrá administrar, si se recomienda dentro de los programas nacionales de vacunación, después de la última extracción de sangre, es decir, después de la visita 6. La vacuna antigripal estacional o pandémica podrá administrarse en cualquier momento del estudio y con arreglo al resumen de características del producto y las recomendaciones nacionales.
•Participación simultánea, en cualquier momento durante el periodo del estudio, en otro ensayo clínico en el que el sujeto haya sido o será expuesto a un producto en investigación o de naturaleza no experimental (producto farmacéutico o sanitario).
•Vacunación previa contra la difteria, tétanos, tos ferina, poliomielitis, hepatitis B, Haemophilus influenzae tipo b, Streptococcus pneumoniae, Neisseria meningitidis de los serogrupos A, C, W-135 o Y, con excepción de las vacunas cuya primera dosis se pueda administrar en las dos primeras semanas de vida según las recomendaciones nacionales (por ejemplo, hepatitis B y BCG).
•Antecedentes de difteria, tétanos, tos ferina, poliomielitis, hepatitis B, enfermedad por Haemophilus influenzae tipo b, enfermedad neumocócica y/o meningocócica, o presencia intercurrente de cualquiera de ellas.
•Cualquier estado de inmunosupresión o inmunodeficiencia conocido o sospechado por la historia clínica y la exploración física (no se exigirá ninguna prueba de laboratorio).
•Antecedentes familiares de inmunodeficiencia congénita o hereditaria.
•Antecedentes de reacción o de hipersensibilidad posiblemente exacerbada por algún componente de la(s) vacuna(s).
•Defectos congénitos importantes o enfermedades crónicas graves.
•Antecedentes de cualquier enfermedad neurológica o crisis convulsiva (se permitirán los antecedentes de una única crisis febril simple).
•Enfermedad aguda y/o fiebre en el momento del reclutamiento.
La fiebre se define como una temperatura ≥ 37,5°C (99,5°F) según el registro oral, axilar o timpánico, o ≥ 38,0°C (100,4°F) según el registro rectal.
Los sujetos con enfermedades leves (del tipo de diarrea leve, infección respiratoria alta leve) sin fiebre podrán, a criterio del investigador, ser reclutados.
•Administración de inmunoglobulinas y/o cualquier hemoderivado desde el nacimiento o administración prevista durante el periodo de estudio

E.5 End points

E.5.1

Primary end point(s)

• Inmunogenicidad con respecto a los componentes de la vacuna en investigación.
Títulos rSBA ≥ 1:8 para cada uno de los cuatro serogrupos en todos los sujetos, un mes después de la pauta de primovacunación

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

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

immunogenicidad

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

abierto

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.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

Última visita del último 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.1.1.1

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.1.1.5

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Se pedirá el consentimiento a los padres o tutores legales

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

800

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1380

F.4.2.2

In the whole clinical trial

1380

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)

En cuanto los datos inmunológicos estén disponibles, a los sujetos que, tras las dosis de recuerdo de la vacuna, tengan una respuesta por debajo del corrrelato de protección establecido y publicado se les ofrecerá una dosis adicional de las vacunas autorizadas

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

2010-05-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-05-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-09-10

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