Clinical Trials Register

Summary
EudraCT Number:	2011-000758-41
Sponsor's Protocol Code Number:	115345
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:	2011-07-22
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

2011-000758-41

A.3

Full title of the trial

Estudio fase III, observador ciego, aleatorizado, multinacional y controlado con una vacuna no antigripal, para demostrar la eficacia de la vacuna antigripal estacional tetravalente de GSK Biologicals GSK2321138A (FLU D-QIV), administrada intramuscularmente en niños de 6 a 35 meses de edad

A.3.1

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

Estudio de eficacia de la vacuna antigripal tetravalente de GSK Biologicals GSK2321138A (FLU D-QIV), administrada en niños

A.3.2

Name or abbreviated title of the trial where available

FLU D-QIV-004 PRI

A.4.1

Sponsor's protocol code number

115345

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 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	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	------------
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	vacuna antigipal estacional tetravalente (Flu D-QIV)
D.3.2	Product code	GSK2321138A
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	A/CALIFORNIA/7/2009 (H1N1)
D.3.9.4	EV Substance Code	SUB30763
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	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NYMC X-187)
D.3.9.4	EV Substance Code	SUB31350
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	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	B/FLORIDA/4/2006-LIKE STRAIN (B/BRISBANE/3/2007)
D.3.9.4	EV Substance Code	SUB29298
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	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	B/BRISBANE/60/2008-LIKE VIRUS
D.3.9.4	EV Substance Code	SUB30542
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	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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Prevenar 13
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth
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	Prevenar 13
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 5 CONJUGADO CON CRM197
D.3.9.4	EV Substance Code	SUB30927
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 1 CONJUGADO CON CRM197
D.3.9.4	EV Substance Code	SUB30925
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 3 CONJUGADO CON CRM197
D.3.9.4	EV Substance Code	SUB30926
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 4 CONJUGADO CON CRM197
D.3.9.4	EV Substance Code	SUB25336
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 6A CONJUGADO CON CRM197
D.3.9.4	EV Substance Code	SUB30928
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 6B CONJUGADO CON CRM197 ADSORBIDO CON FOSFATO DE ALUMINIO
D.3.9.4	EV Substance Code	SUB25344
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 7F CONJUGADO CON CRM197
D.3.9.4	EV Substance Code	SUB30929
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 7V CONJUGADO CON CRM197 ADSORBIDO CON FOSFATO DE ALUMINIO
D.3.9.4	EV Substance Code	SUB25342
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 14 CONJUGADO CON CRM197 ADSORBIDO CON FOSFATO DE ALUMINIO
D.3.9.4	EV Substance Code	SUB25340
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 18C
D.3.9.4	EV Substance Code	SUB20580
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 19A CONJUGADO CON CRM197
D.3.9.4	EV Substance Code	SUB30930
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 19F CONJUGADO CON CRM197 ADSORBIDO CON FOSFATO DE ALUMINIO
D.3.9.4	EV Substance Code	SUB25366
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	POLISACARIDO DE NEUMOCOCO SEROTIPO 23F CONJUGADO CON CRM197 ADSORBIDO CON FOSFATO DE ALUMINIO
D.3.9.4	EV Substance Code	SUB25347
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	2.2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Varivax/ProVarivax
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur MSD
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	Varivax/ProVarivax
D.3.4	Pharmaceutical form	Powder and solvent 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	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS
D.3.9.4	EV Substance Code	SUB25312
D.3.10	Strength
D.3.10.1	Concentration unit	PFU/dose plaque forming unit(s)/dose
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1350
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Varilrix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
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	Varilrix
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	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	VARICELLA VIRUS
D.3.9.4	EV Substance Code	SUB20954
D.3.10	Strength
D.3.10.1	Concentration unit	PFU/dose plaque forming unit(s)/dose
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1033
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Havrix Junior
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
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.3.1	Product name	Havrix Junior
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	N/A
D.3.9.3	Other descriptive name	VIRUS DE LA HEPATITIS A (INACTIVADA) ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED PRODUCED ON HUMAN DIPLOID (MRC-5) CELLS
D.3.9.4	EV Substance Code	SUB25294
D.3.10	Strength
D.3.10.1	Concentration unit	ELISA unit enzyme-linked immunosorbent assay unit
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	720
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Inmunización frente a la gripe A y/o B (vacuna candidata frente a la gripe de GSK Biologicals, 2321138A) de niños sanos de 6 a 35 meses de edad

E.1.1.1

Medical condition in easily understood language

Gripe estacional

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10022000
E.1.2	Term	Influenza
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

Evaluar la eficacia de FLU D-QIV en la prevención de la enfermedad gripal A y/o B confirmada mediante RCP-TI causada por cualquiera de las cepas estacionales, en comparación con referencias distintas a la vacuna antigripal en niños de 6 a 35 meses.

E.2.2

Secondary objectives of the trial

EVALUAR:
-La eficacia de FLU D-QIV para prevenir la enfermedad gripal confirmada mediante cultivo
-para las cepas antigénicas idénticas a las vacunales,
-para cualquier cepa gripal estacional
- La eficacia de FLU D-QIV en la prevención de gripe moderada o severa confirmados mediante RCP-TI
-La eficacia de FLU D-QIV para prevenir la OMA asociada a la gripe confirmada mediante RCP-TI
-La eficacia de FLU D-QIV para prevenir la EVRB asociada a la gripe confirmada mediante RCP-TI
-La eficacia de FLU D-QIV para prevenir la gripe severa confirmada mediante RCP-TI
-La inmunogenicidad de la vacuna FLU D-QIV, en función de la respuesta de anticuerpos IH, en una subcohorte de sujetos.
-La reactogenicidad de FLU D-QIV y comparadores , a juzgar por los acontecimientos adversos (AA) locales y generales , por síntomas no solicitados, AA que exijan visita con asistencia médica (VAM), acontecimientos adversos graves (AAG) y enfermedades de posible mediación inmunitaria (EPMI).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

?Sujetos cuyos padres/RLA puedan y deseen cumplir, en opinión del investigador, los requisitos del protocolo (p. ej., cumplimentación de las tarjetas diario, notificación de SG o VAM mediante acceso por internet, disponibilidad para los contactos telefónicos durante el seguimiento).
?Niños o niñas de entre 6 y 35 meses de edad, ambos inclusive, en el momento de la primera vacunación; se considerará elegibles todos los niños, con independencia de los antecedentes de vacunación antigripal.
?Consentimiento informado y firmado por los padres/RLA del sujeto.
?Sujetos con una salud estable determinada a partir de la historia clínica y de la exploración física previa al inicio del estudio.

E.4

Principal exclusion criteria

- Niño bajo custodia:
- Uso de un producto en investigación o no registrado (medicamento o vacuna) diferente de las vacunas del estudio, en los 30 días anteriores a la administración de la primera dosis de la vacuna del estudio, o uso planificado durante el periodo de estudio.
- Administración previa de cualquier vacuna antigripal (registrada o en investigación) durante el semestre previo a la primera dosis de la vacuna del estudio, o uso previsto de estas vacunas durante el periodo de estudio.
- Antecedentes de hepatitis A o de varicela (si el niño tiene ?12 meses).
- Cualquier trastorno confirmado o sospechado de inmunosupresión o inmunodeficiencia (incluida la infección por VIH) de acuerdo con la historia clínica y la exploración física (no se exigirá ninguna prueba de laboratorio).
- Administración crónica (definida por una duración mayor de 14 días en total) de inmunosupresores o de inmunomoduladores durante los seis meses anteriores a la administración de la primera dosis de la vacuna. En el caso de los corticoides, esto significa una dosis equivalente a ? 0,5 mg/kg de peso corporal o un máximo de 10 mg/día de prednisona o sus equivalentes. Se permite el uso inhalado y tópico de esteroides.
- Administración de inmunoglobulinas y/o cualquier hemoderivado en los 3 meses previos a la administración de la primera dosis de la vacuna del estudio o administración prevista durante el periodo de estudio.
- Cualquier alergia conocida o sospechada a cualquier componente de las vacunas antigripales (incluidas las proteínas del huevo), o cualquier componente de las vacunas de referencia distintas a la antigripal (incluida la neomicina) y látex; antecedentes de reacción anafiláctica al consumo de huevos; o antecedentes de reacción adversa grave a una vacuna previa.
- Contraindicación para la inyección intramuscular.
- Enfermedad aguda o fiebre o ambas en el momento del reclutamiento.
La fiebre se define como una temperatura >= 37,5°C oral o axilar. Los sujetos con enfermedades leves (del tipo de diarrea o infección respiratoria alta leve) sin fiebre podrán ser reclutados, si el investigador lo cree oportuno.
- Cualquier otro trastorno que, en opinión del investigador, impida al sujeto participar en el estudio.
Criterios adicionales para los niños >= 12 meses de edad:
- Recepción previa de cualquier vacuna antivaricela* registrada o de cualquier vacuna frente a la hepatitis A registrada o uso previsto de estas vacunas durante el periodo de estudio. Se permitirá el uso de otras vacunas pediátricas sistemáticas registradas.
* España: Se admitirá la recepción previa de una dosis de la vacuna Varivax si se administra por lo menos 2 semanas antes de la primera vacunación del estudio. La decisión acerca de la necesidad de la vacunación de la varicela después del estudio se tomará cuando se desenmascare a los sujetos, sobre la base de los antecedentes vacunales de cada sujeto y la ficha técnica.
- Antecedentes de hepatitis A o de varicela.
Criterios adicionales para los niños de 6 - 11 meses de edad en los países sin una recomendación para la vacunación masiva universal frente al neumococo:
- Recepción previa de cualquier vacuna antineumocócica conjugada o uso previsto de esta vacuna durante el periodo de estudio. Se permitirá el uso de otras vacunas pediátricas de administración sistemática.

E.5 End points

E.5.1

Primary end point(s)

?Primer episodio de enfermedad gripal A y/o B confirmado por RCP-TI causado por cualquier cepa de la gripe durante el periodo de vigilancia de la gripe.
? La variable principal exigirá un resultado de RCP-TI positivo para el virus de la gripe A y/o B del frotis nasal , juntamente con SG (fiebre y al menos un síntoma respiratorio), OMA o EVRB

E.5.1.1

Timepoint(s) of evaluation of this end point

Durante el periodo de vigilancia de la gripe

E.5.2

Secondary end point(s)

Eficacia:
?Primer episodio de enfermedad gripal A y/o B confirmada por el cultivo, según se define en la variable principal, debida a cepas de gripe antigénicamente idénticas, durante el periodo de vigilancia de la gripe.
?Primer episodio de enfermedad gripal A y/o B confirmada por cultivo, según se describe para la variable principal, producida por cualquier cepa de gripe, durante el periodo de vigilancia de esta enfermedad.
?Primer episodio de enfermedad gripal* A y/o B moderada o severa confirmada mediante RCP-TI durante el periodo de vigilancia de gripe.
?Primer episodio de OMA con gripe A y/o B confirmada por RCP-TI causada por cualquier cepa de la gripe detectada desde 7 días antes del inicio de la OMA hasta 7 días después de su terminación durante el periodo de vigilancia de la gripe
?Primer episodio de EVRB con gripe A y/o B confirmada por RCP-TI causada por cualquier cepa de la gripe detectada desde 7 días antes del inicio de la EVRB hasta 7 días después de su terminación durante el periodo de vigilancia de la gripe
?Primer episodio de gripe severa A y/o B confirmada por RCP-TI durante el periodo de vigilancia de la gripe.
Inmunogenicidad:
?Respuesta inmunitaria humoral basada en los títulos de anticuerpos inhibidores de la hemaglutinación (IH) frente a cada una de las cuatro cepas vacunales contenidas en FLU D-QIV (en la subcohorte de inmunogenicidad de sujetos exclusivamente).
Safety:
?Síntomas solicitados locales y generales
?Acontecimientos adversos (AA) no solicitados)
?AA con VAM
?AAG
?EPMI

E.5.2.1

Timepoint(s) of evaluation of this end point

Eficacia
?Durante el periodo de vigilancia de la gripe
Inmunogenicidad
?Media geométrica de los títulos (MGT) de anticuerpos IH en los días 0 y 28/56.
?Tasas de seropositividad en los días 0 y 28/56.
?Tasas de seroconversión (SCR) en el día 28/56.
?Incremento geométrico medio (MGI) en el día 28/56.
?Tasas de seroprotección (SPR) en los días 0 y 28/56
Seguridad
?Síntomas solicitados locales y generales durante los 7 días (días 0-6) posteriores a cada vacunación
?Acontecimientos adversos (AA) no solicitados en los 28 días (días 0-27) posteriores a cada vacunación
?AA con VAM, AAG y EPMI: durante todo el periodo de estudio

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

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

Último sujeto, última visita

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:

8200

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:

4100

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

4100

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

Los sujetos son niños de edad entre 6 y 35 meses. El consentimiento informado se obtendrá de los padres o tutores legales de los sujetos

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

600

F.4.2

For a multinational trial

F.4.2.1

In the EEA

8200

F.4.2.2

In the whole clinical trial

8200

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)

Se ha previsto un plan de vacunación para los sujetos que reciban las vacunas no antigripales (grupo control), efectivo a la conclusión de su participación. Se administrará una dosis de recuerdo de Prevenar o Havrix, y si procede, una dosis de Varilrix o Varivax/ProVarivax tras la finalización del estudio una vez se cierre la base de datos y se abra el ciego, en función de la historia de vacunación de cada sujeto y conforme a las pautas de vacunación descritas en la ficha técnica de las vacunas.

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

2011-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-31

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