Clinical Trials Register

Summary
EudraCT Number:	2006-003762-33
Sponsor's Protocol Code Number:	106481
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:	2012-08-13
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

2006-003762-33

A.3

Full title of the trial

A phase IIIb, double blind, randomised, placebo?controlled, multi?country, multicentre study to assess the safety, reactogenicity and immunogenicity of two doses of GlaxoSmithKline (GSK) Biologicals? oral live attenuated Human Rotavirus (HRV) Vaccine in pre?term infants.

Estudio fase IIIb, doble ciego, aleatorizado, controlado con placebo, multinacional, multicéntrico para evaluar la seguridad, reactogenicidad e inmunogenicidad de dos dosis de la vacuna antirrotavirus de origen humano (RVH) viva atenuada y de administración oral de GlaxoSmithKline (GSK) Biologicals en niños prematuros

A.3.1

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

To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants.

Evaluar la seguridad, reactogenicidad e inmunogenicidad de dos dosis de la vacuna antirrotavirus de origen humano (RVH) viva atenuada y de administración oral de GlaxoSmithKline (GSK) Biologicals en niños prematuros.

A.3.2

Name or abbreviated title of the trial where available

Rota-054

A.4.1

Sponsor's protocol code number

106481

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
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	Yes
D.2.1.1.1	Trade name	Rotarix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals
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.3.4	Pharmaceutical form	Powder and solvent for oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Human rota virus RIX4414 strain
D.3.9.3	Other descriptive name	Human rota virus RIX4414 strain
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50 cell culture infective dose 50
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1000000
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	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
D.2.1.1.2	Name of the Marketing Authorisation holder	GSK Biologicals
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.3.4	Pharmaceutical form	Powder and suspension for suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphtheria toxoid
D.3.9.2	Current sponsor code	DT
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	Tetanus toxoid
D.3.9.2	Current sponsor code	TT
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	Pertussis toxoid
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	Pertussis 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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Filamentous haemagglutinin
D.3.9.3	Other descriptive name	Filamentous haemagglutinin
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	Pertactin
D.3.9.3	Other descriptive name	Pertactin
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	Hepatitis B surface antigen
D.3.9.3	Other descriptive name	Hepatitis B surface antigen
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 1(Mahoney Strain)
D.3.9.3	Other descriptive name	Inactivated polio virus type 1(Mahoney Strain)
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen 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	Inactivated polio virus type 2 (MEF 1 strain)
D.3.9.3	Other descriptive name	Inactivated polio virus type 2 (MEF 1 strain)
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen 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	Inactivated polio virus type 3 (Saukett strain)
D.3.9.3	Other descriptive name	Inactivated polio virus type 3 (Saukett strain)
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haemophilus influenzae type b polysaccharide
D.3.9.3	Other descriptive name	Haemophilus influenzae type b polysaccharide
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)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Yes
D.2.1.1.1	Trade name	Infanrix-IPV+Hib
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 suspension for suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphtheria toxoid
D.3.9.2	Current sponsor code	DT
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	Tetanus toxoid
D.3.9.2	Current sponsor code	TT
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	Pertussis toxoid
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	Pertussis 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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Filamentous haemagglutinin
D.3.9.3	Other descriptive name	Filamentous haemagglutinin
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	Pertactin
D.3.9.2	Current sponsor code	PRN
D.3.9.3	Other descriptive name	Pertactin
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	Inactivated polio virus type 1 (Mahoney Strain)
D.3.9.3	Other descriptive name	Inactivated polio virus type 1 (Mahoney Strain)
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen 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	Inactivated polio virus type 2 (MEF 1 strain)
D.3.9.3	Other descriptive name	Inactivated polio virus type 2 (MEF 1 strain)
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen 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	Inactivated polio virus type 3 (Saukett strain)
D.3.9.3	Other descriptive name	Inactivated polio virus type 3 (Saukett strain)
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haemophilus influenzae type b polysaccharide
D.3.9.3	Other descriptive name	Haemophilus influenzae type b polysaccharide
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)	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	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	Engerix-B
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	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	Hepatitis B recombinant surface antigen
D.3.9.3	Other descriptive name	Hepatitis B recombinant surface antigen
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	Prevenar
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth Lederle Vaccines S.A.
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.3.4	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	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO THE CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO THE CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.4	EV Substance Code	SUB25261
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
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
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: 6
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	NeisVac-C
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	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. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED)
D.3.9.3	Other descriptive name	N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED)
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)	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral suspension
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary immunisation of pre?term infants against human rotavirus gastroenteritis (GE)

Inmunogenicidad primaria de niños prematuros frente a la gastroenteritis causada por rotavirus humano

E.1.1.1

Medical condition in easily understood language

Rotavirus gastroenteritis

Gastroenteritis causada por rotavirus humano

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10039232
E.1.2	Term	Rotavirus gastroenteritis
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 assess the safety of GSK Biologicals? HRV vaccine in terms of occurrence of serious adverse events (SAEs), throughout the study period in pre?term infants receiving HRV vaccine versus pre?term infants receiving placebo.

Evaluar la seguridad de la vacuna antirrotavirus de origen humano de GSK Biologicals en función del número de acontecimientos adversos graves (AAG), acaecidos a lo largo del periodo de estudio, entre prematuros que reciban la vacuna antirrotavirus de origen humano en comparación con otros que reciban placebo

E.2.2

Secondary objectives of the trial

?To assess the safety of GSK Biologicals? HRV vaccine in terms of unsolicited adverse events (AEs) within 31 days (Day 0?Day 30) after any dose of the HRV vaccine/Placebo, in pre?term infants receiving HRV vaccine versus pre?term infants receiving placebo.
In a subset of subjects (N = 300)
Reactogenicity
?To assess the reactogenicity of GSK Biologicals? HRV vaccine in terms of occurrence of solicited symptoms within 15 days (Day 0?Day 14) after each dose of the HRV vaccine/Placebo in pre?term infants receiving HRV vaccine versus pre?term infants receiving placebo.
Immunogenicity
?To assess the immunogenicity of GSK Biologicals? HRV vaccine at Visit 3 (Month 2 or 3), when administered concomitantly with routine immunisation.

Seguridad ?Evaluar la seguridad de la vacuna antirrotavirus de origen humano de GSK Biologicals a partir de los acontecimientos adversos (AA) no solicitados durante los 31 días (días 0-30) siguientes a la administración de cualquier dosis de la vacuna RVH/placebo, entre prematuros que reciban la vacuna antirrotavirus de origen humano en comparación con otros que reciban un placebo. En un subgrupo de sujetos (N = 300), Reactogenicidad ?Evaluar la reactogenicidad de la vacuna antirrotavirus de origen humano de GSK Biologicals en función del número de síntomas solicitados durante los 15 días (días 0?14) siguientes a cada dosis de la vacuna antirrotavirus de origen humano/placebo entre prematuros que reciban la vacuna RVH en comparación con otros que reciban un placebo. Inmunogenicidad ?Evaluar la inmunogenicidad de la vacuna antirrotavirus de origen humano de GSK Biologicals en la 3ª visita (2º o 3er mes) durante su administración concomitante con la vacunación habitual

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow?up visits) should be enrolled in the study. ?A male or female infant between, and including, 6 and 14 weeks (42 ? 104 days) of age at the time of first study vaccination in Portugal, France and Poland. A male or female infant between, and including, 6 and 12 weeks of age at the time of first study vaccination in Spain. ?Written informed consent obtained from the parent/guardian of the subject. ?Medically stable* pre?term infants, born within a gestational period of 27 ?36 weeks. * Medically stable refers to the condition of pre?term infants who do not require significant medical support or ongoing management for a debilitating disease and who have demonstrated a clinical course of sustained recovery as established by medical history and physical examination before entering into the study. ?Planned to be discharged from hospital?s neonatal stay on or before the day of the first HRV vaccine/Placebo administration

? Sujetos cuyos padres/tutores puedan y deseen cumplir, en opinión del investigador, los requisitos del protocolo (p. ej., cumplimentación de las fichas diarias, retorno a las visitas de seguimiento).
? Lactantes de ambos sexos con una edad de entre 6 y 14 semanas ( 42-98 días) en el momento de la primera vacunación del estudio en Portugal, Francia y Polonia. Lactantes de ambos sexos con edad entre 6 y 12 semanas en el momento de la primera vacunación del estudio en España.
? Obtención de la firma del consentimiento informado por los padres/tutores del sujeto.
? Lactantes prematuros clínicamente estables*, nacidos tras un período de gestación de 27 a 36 semanas.
* Clínicamente estable se refiere a un estado de los prematuros que no exija un soporte médico importante o el tratamiento continuo de una enfermedad debilitante y a una recuperación clínica sostenida de los niños, establecida a través de la anamnesis y exploración física previa a la inclusión en el estudio.
? Previsión del alta del servicio hospitalario de neonatología en o antes del día de la primera administración de la vacuna RVH/placebo

E.4

Principal exclusion criteria

?Use of any investigational or non?registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
?Chronic administration (defined as more than 14 days) of immunosuppressants or other immune?modifying drugs from birth to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
?Planned administration/administration of a vaccine not foreseen (except routine paediatric vaccines) by the study protocol within the period starting from birth up to study end.
?Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non?investigational product (pharmaceutical product or device).
?Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
?Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
?History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
?Major congenital defects or serious chronic illness.
?History of any neurologic disorders or seizures. Grade I and II intra?ventricular bleeding are allowed.
?Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low?grade febrile illness, i.e. Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F)
?Administration of immunoglobulins, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the study period. Monoclonal anti?RSV therapy/prophylaxis and recombinant erythropoietin are allowed.

? Uso de algún producto en fase de investigación o no registrado (medicamento o vacuna) distinto de la vacuna del estudio durante los 30 días anteriores a la primera dosis de la vacuna del estudio o uso previsto durante el período de estudio.
? Administración crónica (definida como más de 14 días) de inmunosupresores u otros inmunomoduladores desde el nacimiento hasta la primera dosis de la vacuna. (En el caso de los corticoides, esto significa una cantidad media de prednisona, o equivalente, ? 0,5 mg/kg.día. Se autorizará el uso de esteroides inhalados y por vía tópica.)
? Administración programada/administración imprevista de una vacuna (salvo las vacunas pediátricas habituales) desde el nacimiento hasta el final del estudio.
? Participación simultánea en otro estudio clínico, en algún momento del estudio, en el que el sujeto haya sido o se vea expuesto a un producto en fase de investigación, o no (producto farmacéutico o sanitario).
? Antecedentes clínicamente relevantes de enfermedad gastrointestinal crónica, incluida cualquier malformación congénita no corregida del tubo digestivo u otros trastornos médicos graves determinados por el investigador
? Inmunodepresión o inmunodeficiencia, confirmada o sospechada por la anamnesis y la exploración física (no se exigirán pruebas de laboratorio).
? Antecedentes de enfermedades o reacciones alérgicas que se pudieran exacerbar por cualquier componente de la vacuna.
? Malformaciones congénitas importantes o enfermedades crónicas graves (sujetos con displasia broncopulmonar que requieran oxígeno terapia continuada serán excluidos).
? Antecedentes de trastornos neurológicos o crisis epilépticas. Se permitirán los antecedentes de hemorragia intraventricular de grado I o II.
? Enfermedad aguda en el momento del reclutamiento. (La enfermedad aguda se define por la presencia de enfermedad moderada o grave, con o sin fiebre.) Todas las vacunas se pueden administrar a personas con enfermedades menores, infección respiratoria de vías altas leve más febrícula o no (es decir, temperatura axilar <37,5°C/rectal <38°C).
? Administración de inmunoglobulinas o hemoderivados durante el mes (30 días) anterior a la administración de la primera dosis de las vacunas del estudio o a aplicación prevista durante el período de investigación. Se permitirá el tratamiento/profilaxis con anticuerpos monoclonales anti-RSV y eritropoyetina recombinante.

E.5 End points

E.5.1

Primary end point(s)

?Occurrence of SAEs throughout the study period

Frecuencia de acontecimientos adversos graves (AAG) durante el estudio

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the study period

Durante todo el periodo de estudio

E.5.2

Secondary end point(s)

a) Occurrence of unsolicited adverse events in all subjects, according to MedDRA classification.
b) Occurrence of each type of solicited symptoms in a subset of subjects.
c) Presence of rotavirus in gastroenteritis stools in all subjects.
d) Seroconversion to anti?rotavirus IgA antibody in a subset of subjects.
e) Serum anti?rotavirus IgA antibody concentration in a subset of subjects.

a)Frecuencia de acontecimientos adversos no solicitados de todos los sujetos según la clasificación MedDRA
b)Frecuencia de cada tipo de síntomas solicitado de un subgrupo de sujetos
c)Presencia de RV en las deposiciones de los lactantes con gastroenteritis en todos los casos
d)Seroconversión a los anticuerpos IgA antirrotavirus en un subgrupo de sujetos
e)Concentración sérica de anticuerpos IgA antirrotavirus en un subgrupo de sujetos

E.5.2.1

Timepoint(s) of evaluation of this end point

a) Within 31 days after any HRV vaccine/Placebo dose.
b) Within 15 days after each HRV vaccine/Placebo dose.
c) From Dose 1 of the HRV vaccine/Placebo up to Visit 3.
d) Visit 3
e) Visit 3

a)Durante los 31 días siguientes a cada dosis de la vacuna antirrotavirus de origen humano/dosis del placebo
b)Durante los 15 días siguientes a cada dosis de la vacuna antirrotavirus de origen humano/dosis del placebo
c)Desde la primera dosis de la vacuna antirrotavirus de origen humano/placebo hasta la 3ª visita
d)Visita 3
e)Visita 3

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

immunogenicity

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)

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

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

Yes

E.8.8

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

Last visit of the Last subject

Ultima 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

Number of subjects for this age range:

1009

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Yes

F.1.1.2.1

Number of subjects for this age range:

1009

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

354

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1009

F.4.2.2

In the whole clinical trial

1009

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)

A plan for treatment or care after the subject has ended the participation in the trial is not provided for prophylactic vaccine studies, as the subjects are healthy and do not need any treatment or care after end of the study.

En estudios de vacunas profilácticas no se facilita un plan para el tratamiento o
cuidado del sujeto una vez que haya finalizado su participación en este estudio, ya que se trata de sujetos sanos que no necesitan ningún tratamiento o cuidado adicional.

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

2006-12-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-03-31

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