Clinical Trials Register

Summary
EudraCT Number:	2010-023947-14
Sponsor's Protocol Code Number:	COMVI-B
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:	2011-09-15
Trial results

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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2010-023947-14

A.3

Full title of the trial

Prospective, Randomized and Comparative Study to evaluate the efficacy of two vaccines against Hepatitis B virus in inflammatory bowel disease patients

ENSAYO CLÍNICO MULTICÉNTRICO, PROSPECTIVO, ALEATORIZADO Y COMPARATIVO PARA EVALUAR LA EFICACIA DE DOS VACUNAS FRENTE AL VIRUS DE LA HEPATITIS B EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL

A.3.1

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

Prospective, Randomized and Comparative Study to evaluate the efficacy of two vaccines against Hepatitis B virus in inflammatory bowel disease patients

ENSAYO CLÍNICO MULTICÉNTRICO, PROSPECTIVO, ALEATORIZADO Y COMPARATIVO PARA EVALUAR LA EFICACIA DE DOS VACUNAS FRENTE AL VIRUS DE LA HEPATITIS B EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL

A.3.2

Name or abbreviated title of the trial where available

COMVI-B Proyect

Proyecto COMVI-B

A.4.1

Sponsor's protocol code number

COMVI-B

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	Hospital Universitario La Princesa
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Hospital Universitario La Princesa
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital Universitario La Princesa
B.5.2	Functional name of contact point	Javier Perez Gisbert
B.5.3	Address:
B.5.3.1	Street Address	C/ Diego de León, 62
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28006
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034913093911
B.5.5	Fax number	0034914022299
B.5.6	E-mail	gisbert@meditex.es

D. IMP Identification
D.IMP: 1
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	ENGERIX-B 20µg / 1ml suspensión inyectable en jeringa precargada
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE, 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.3.1	Product name	FENDRIX
D.3.2	Product code	Not Applicable
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	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	40
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	FENDRIX, suspensión 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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	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	20
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

Prophylaxis against Hepatitis B virus

Profilaxis contra el virus de la hepatitis B

E.1.1.1

Medical condition in easily understood language

Prophylaxis against Hepatitis B virus

Profilaxis contra el virus de la hepatitis B

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10019743
E.1.2	Term	Hepatitis B virus (HBV)
E.1.2	System Organ Class	10022891 - Investigations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the response rate to the vaccination to HBV in IBD patients.

1º) Evaluar la tasa de respuesta frente a la vacunación por el VHB en los pacientes con EII.

E.2.2

Secondary objectives of the trial

1) To compare response rate to the vaccination to HBV in patients with IBD of two types of vaccines:
a) Engerix (double dose) in months 0, 1, 2 and 6
b) Fendrix in months 0,1,2 and 6
2) To identify the predictor factors to the HBV vaccine response (Specially in the treatment with immunosupresors such as azathioprine / mercaptopurine or biological treatment such as infliximab/adalimumab).

3) To study the kinetics of the decrease of anti-HBs title overtime in patients that initially responded to the HBV vaccine (this objective will be evaluated in a follow-up study)

1º) Comparar la tasa de respuesta a la vacunación del VHB en los pacientes con EII de 2 tipos de vacuna:
a) Engerix (doble dosis) a los meses 0, 1, 2 y 6.
b) Fendrix a los meses 0, 1, 2 y 6. 3º)

2º) Identificar los factores predictores de respuesta a la vacuna del VHB (especialmente el tratamiento con inmunosupresores como la azatioprina/mercaptopurina o biológicos como el infliximab/adalimumab).

3º) Conocer la cinética del descenso de los títulos de anti-HBs a lo largo del tiempo en los pacientes que inicialmente respondieron a la vacuna del VHB. (Este objetivo se evaluará en un estudio posterior de continuación).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Patients diagnosed of IBD with negative HBV serology.

2) Men & women commited to abstinence of sexual relations or to use, al least, an effective birth control method (condom, diaphragm, IUD)

1-Pacientes diagnosticados de EII con serología del VHB negativa.

2- Mujeres y hombres que se comprometan a abstenerse de mantener relaciones sexuales o a utilizar, al menos, un método anticonceptivo eficaz (preservativo, diafragma, DIU)

E.4

Principal exclusion criteria

1- Age below 18 years old.
2- Advanced Chronic Disease or any other disease that prevent from attending controls and follow-up.
3- Allergy to any of the vaccine components.
4- Previous vaccination to the HBV.
5- Women willing to get pregnant.
6- Pregnancy or breastfeeding.
7- alcohol abuse.
8- Positive serology to HBV.
9- People with immune disorders caused by other causes than treatments administered to control IBD.
10- People with chronic antibiotic treatment.
11- Lack of consent for participating in the study.

1-Edad inferior a 18 años.
2-Enfermedad crónica avanzada o cualquier otra patología que impida acudir a controles y seguimiento.
3-Alergia a algún componente de la vacuna.
4- Vacunación previa a VHB.
5- Mujeres que deseen quedarse embarazadas.
6-Embarazo o lactancia.
7- Abuso de alcohol.
8- Tener serología positiva para el VHB
9-Personas con alteraciones de la inmunidad por otras causas que no sean los tratamientos administrados para el control de la EII
10-Personas con tratamientos prolongados con antibióticos
11-Negativa a dar el consentimiento para la participación en el estudio.

E.5 End points

E.5.1

Primary end point(s)

The main outcome will be the response to the vaccine defined as an anti-HBs title of 100 mUI/ml in month 2 after the last vaccine dose.

La variable principal será la respuesta a la vacuna, definida como un título de anti-HBs 100 mUI/ml a los 2 meses de la última dosis de vacuna

E.5.1.1

Timepoint(s) of evaluation of this end point

Two months after the last vaccine dose ( eight months after the start of the clinical trial)

Dos meses después de la última dosis de vacuna (a los 8 meses del inicio del ensayo clínico)

E.5.2

Secondary end point(s)

The response to the vaccine in accordance with age of the patient, gender, the type of IBD (Crohn´s Disease or ulcerative colitis) and the concomitant treatments.

La respuesta a la vacuna en función de la edad del paciente, el sexo, el tipo de enfermedad inflamatoria intestinal (enfermedad de Crohn o colitis ulcerosa) y los tratamientos concomitantes.

E.5.2.1

Timepoint(s) of evaluation of this end point

Two months after the last vaccine dose ( eight months after the start of the clinical trial)

Dos meses después de la última dosis de vacuna (a los 8 meses del inicio del ensayo clínico)

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

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

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

Last follow-up visit of the last patient of the clinical trial.

Fecha en la que el último paciente completa la visita de seguimiento del estudio.

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

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

118

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

118

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

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

Yes

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

236

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)

Not applicable

No aplica

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

2011-07-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-03-10

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

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