Clinical Trials Register

Summary
EudraCT Number:	2016-000598-19
Sponsor's Protocol Code Number:	115461
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:	2017-03-10
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

2016-000598-19

A.3

Full title of the trial

A phase IIIA, randomised, observer-blind, multi-centre study to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of GSK Biologicals’ HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks.

Estudio fase IIIA, multicéntrico, aleatorizado y observador ciego para evaluar la consistencia de tres lotes de producción de la formulación líquida de la vacuna oral humana atenuada frente al rotavirus (RVH) de GlaxoSmithKline (GSK) Biologicals sin circovirus porcino (PCV) y evaluar la formulación líquida de la vacuna frente al RVH de GSK Biologicals sin PCV en comparación con la formulación liofilizada de la vacuna frente al RVH autorizada actualmente en cuanto a inmunogenicidad, reactogenicidad y seguridad, administrada como pauta de vacunación de dos dosis a lactantes sanos a partir de las 6 12 semanas de vida

A.3.1

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

Evaluation of immunogenicity and safety of two formulations of human rotavirus (HRV) vaccine, in healthy infants starting at age 6-12 weeks.

Evaluación de la inmunogenicidad y seguridad de dos formulaciones de la vacuna humana frente al rotavirus (RVH) en lactantes sanos a partir de las 6 12 semanas de vida.

A.3.2

Name or abbreviated title of the trial where available

ROTA-081

A.4.1

Sponsor's protocol code number

115461

A.5.4

Other Identifiers

Name:

IND Number

Number:

BB-IND-16992

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 S.A.
B.5.2	Functional name of contact point	Centro de Información
B.5.3	Address:
B.5.3.1	Street Address	Severo Ochoa 2
B.5.3.2	Town/ city	Tres Cantos
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34902202700
B.5.5	Fax number	+34918070479
B.5.6	E-mail	es-ci@gsk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Vacuna RVH sin PCV liquido
D.3.2	Product code	Vacuna RVH sin PCV liquido
D.3.4	Pharmaceutical form	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	-
D.3.9.3	Other descriptive name	Rotavirus humano cepa RIX4414 (viva atenuada)
D.3.9.4	EV Substance Code	SUB22357
D.3.10	Strength
D.3.10.1	Concentration unit	log10 CCID50/dose log10 cell culture infective dose 50/dose
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	6.0
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	Rotarix
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	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	-
D.3.9.3	Other descriptive name	Rotavirus humano cepa RIX4414 (viva atenuada)
D.3.9.4	EV Substance Code	SUB22357
D.3.10	Strength
D.3.10.1	Concentration unit	log10 CCID50/dose log10 cell culture infective dose 50/dose
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	6.0
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

Rotarix is indicated to prevent infants against gastroenteritis (GE) due to rotavirus (RV).

Rotarix esta indicada en la prevención de lactantes frenta a la gastroenteritis (GE) por rotavirus (RV).

E.1.1.1

Medical condition in easily understood language

Rotarix is a vaccine that protects infants against diarrhoea, vomiting, nausea and fever.

Rotarix es una vacuna que protege a los lactantes frente a la diarrea, vómitos, nausea y fiebre

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	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10039232
E.1.2	Term	Rotavirus gastroenteritis
E.1.2	System Organ Class	100000004862

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 demonstrate the lot-to-lot consistency of the PCV-free liquid HRV vaccine in terms of immunogenicity as measured by serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.
•To demonstrate the immunological non-inferiority of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine in terms of seroconversion rates 1-2 months after Dose 2.
•To demonstrate the non-inferiority of the PCV-free liquid HRV vaccine to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.

-Demostrar la uniformidad lote a lote de la vacuna frente al RVH líquida sin PCV en cuanto a la inmunogenicidad, medida mediante las concentraciones séricas de anticuerpo IgA anti RV 1 2 meses después de la dosis 2.
-Demostrar la ausencia de inferioridad inmunológica de la vacuna frente al RVH líquida sin PCV con respecto a la vacuna frente al RVH liofilizada autorizada actualmente en cuanto a las tasas de seroconversión 1 2 meses después de la dosis 2.
-Demostrar la ausencia de inferioridad de la vacuna frente al RVH liquida sin PCV con respecto a la vacuna frente al RVH liofilizada autorizada actualmente en cuanto a la concentración sérica de anticuerpos IgA anti RV 1 2 meses después de la dosis 2.

E.2.2

Secondary objectives of the trial

Reactogenicity and safety
•To evaluate the reactogenicity of the liquid HRV vaccine and currently licensed lyophilised HRV vaccine in terms of solicited AEs during the 8 days (Day 0-Day 7) follow-up period after each vaccination.
•To assess the safety of the study vaccines in terms of unsolicited AEs during the 31 days (Day 0-Day 30) follow-up period after each vaccination and Serious Adverse Events (SAEs) during the entire study period.

Immunogenicity
•To assess the immunogenicity of the PCV-free liquid HRV vaccine and the currently licensed lyophilised HRV vaccine, in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL 1-2 months after Dose 2.

Reactogenicidad y seguridad
-Evaluar la reactogenicidad de la vacuna frente al RVH líquida y la vacuna frente al RVH liofilizada autorizada actualmente en cuanto a los AA notificados durante el periodo de seguimiento de 8 días (día 0 día 7) después de cada vacunación.
-Evaluar la seguridad de las vacunas del estudio en cuanto a los AA notificados durante el periodo de seguimiento de 31 días (día 0 día 30) después de cada vacunación y los acontecimientos adversos graves (AAG) durante todo el periodo del estudio.
Inmunogenicidad
-Evaluar la inmunogenicidad de la vacuna frente al RVH liquida sin PCV y la vacuna frente al RVH liofilizada autorizada actualmente en cuanto al porcentaje de participantes con concentraciones de anticuerpos IgA anti RV ≥ 90 U/ml 1 2 meses después de la dosis 2.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects’ parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
•A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
•Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
•Healthy subjects as established by medical history and clinical examination before entering into the study.

-Padres o RAL del niño que, en opinión del investigador, puedan cumplir y cumplan los requisitos del protocolo.
-Consentimiento informado por escrito obtenido de los padres/RAL del niño antes de realizar ningún procedimiento específico del estudio.
-Lactantes de ambos sexos y de 6 a 12 semanas (42 90 días) de vida en el momento de la primera vacunación del estudio.
-Nacidos a término completo (es decir, un periodo de gestación de 37 semanas 0 días a 41 semanas 6 días).
-Lactantes sanos según la historia clínica y la exploración física antes de la inclusión en el estudio.

E.4

Principal exclusion criteria

•Child in care
•Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Administration of long-acting immune-modifying drugs at any time during the study period.
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
•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 vaccine/product.
•Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
•History of IS.
•Family history of congenital or hereditary immunodeficiency.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•Major congenital defects or serious chronic illness.
•Previous vaccination against RV.
•Previous confirmed occurrence of RVGE.
•GE within 7 days preceding the study vaccine administration.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
•Hypersensitivity to latex.
•Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator

-Niño en acogida
-Uso de cualquier producto (fármaco o vacuna) en investigación o no registrado distinto de las vacunas del estudio durante el período iniciado 30 días antes de la primera dosis de la vacuna del estudio (día 29 a día 0) o uso previsto durante el periodo del estudio.
-Administración prolongada (definida como más de 14 días en total) de inmunodepresores u otros fármacos inmunomoduladores desde el nacimiento. En cuanto a los corticosteroides, eso significará una dosis media de prednisona de 0,5 mg/kg al día o equivalente. Se permitirá el uso de esteroides inhalados y tópicos.
-Administración de inmunoglobulinas o de cualquier hemoderivado desde el nacimiento o administración prevista durante el periodo del estudio.
-Administración de fármacos inmunomoduladores de acción prolongada en cualquier momento durante el período del estudio.
-Administración programada/administración de una vacuna no prevista en el protocolo del estudio en el período iniciado 30 días antes de la primera dosis de la de la vacuna y finalizado en la visita 3, con la salvedad de la vacuna antigripal de virus inactivados, que está permitida en cualquier momento durante el estudio, y otras vacunas infantiles habituales autorizadas.
-Participación simultánea en otro estudio clínico, en cualquier momento del período de estudio, en que el lactante haya estado expuesto o vaya a exponerse a un producto/vacuna en investigación o no (fármaco o producto sanitario).
-Malformación congénita no corregida del tubo digestivo que predisponga a la invaginación.
-Antecedente de invaginación.
-Antecedentes familiares de inmunodeficiencia congénita o hereditaria.
-Cualquier enfermedad causante de inmunodepresión o inmunodeficiencia confirmada o supuesta, basándose en los antecedentes médicos y la exploración física
-Anomalía congénita importante o enfermedad crónica grave.
-Vacunación previa frente al RV.
-Episodio previo confirmado de GERV.
-GE en los 7 días previos a la administración de las vacunas del estudio.
-Antecedentes de cualquier reacción o hipersensibilidad que probablemente pueda agravarse por alguno de los componentes de la vacuna.
-Hipersensibilidad al látex.
-Enfermedad aguda o fiebre en el momento de la inclusión
 La fiebre se define como una temperatura ≥ 38,0 °C. El lugar preferido para medir la temperatura en este estudio será la cavidad bucal, la axila y el recto.
 Los lactantes con enfermedad leve (como diarrea leve, infección leve de las vías respiratorias superiores) y sin fiebre pueden participar a criterio del investigador.

E.5 End points

E.5.1

Primary end point(s)

Evaluation of immunogenicity in terms of anti-RV antibody concentrations.
-Serum anti-RV IgA antibody concentrations expressed as GMCs in each of the HRV liquid formulation groups (Liq_A, Liq_B and Liq_C).
-Anti-RV IgA antibody seroconversion rate* in the lyophilised and pooled liquid groups.
-Serum anti-RV IgA antibody concentrations expressed as GMCs in the lyophilised and pooled liquid groups.
*Seroconversion rate is defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration < 20 U/mL prior the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration ≥ 20 U/mL at Visit 3.

Evaluación de la inmunogenicidad en cuanto a la concentración de anticuerpos anti RV
Concentración sérica de anticuerpos IgA anti RV expresada como MGC en cada uno de los grupos de la formulación líquida de RVH (Liq_A, Liq_B y Liq_C).
Tasa de seroconversión de anticuerpos IgA Anti RV* en los grupos de la vacuna liofilizada y los grupos de la vacuna líquida combinados.
Concentración sérica de anticuerpos IgA anti RV expresada como MGC en el grupo de la vacuna liofilizada y los grupos de la vacuna liquida combinados.
*La tasa de seroconversión se define como el porcentaje de participantes que sean inicialmente seronegativos (es decir, con una concentración de anticuerpos IgA anti RV < 20 U/ml antes de la primera dosis de la vacuna frente al RVH) y presenten una concentración de anticuerpos IgA anti RV ≥ 20 U/ml en la visita 3.

E.5.1.1

Timepoint(s) of evaluation of this end point

1-2 months after Dose 2

1 2 meses después de la dosis 2

E.5.2

Secondary end point(s)

1. Number of subjects with solicited adverse events.
2. Number of subjects with unsolicited adverse events.
3. Number of subjects with serious adverse events.
4. Number of subjects with serum anti-RV IgA antibody concentrations ≥ 90 U/mL in the lyophilised and pooled liquid groups.

1. Número de sujetos con acontecimientos adversos solicitados
2. Número de sujetos con acontecimientos adversos no solicitados
3. Número de sujetos con acontecimientos adversos graves
4. Número de sujetos con concentración sérica de anticuerpos IgA anti RV ≥ 90 U/ml en el grupo de la vacuna liofilizada y los grupos de la vacuna líquida combinados.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Within the 8 days (Day 0-Day 7) follow-up period
2. Within 31 days (Day 0-Day 30) after any dose of HRV vaccine
3. Dose 1 up to the study end
4. 1-2 months after Dose 2

1. En el periodo de seguimiento de 8 días (día 0 día 7)
2. En los 31 días (días 0 30) siguientes a cualquier dosis de la vacuna frente al RVH
3. Desde la dosis 1 hasta el final del estudio.
4. 1- 2 meses después de la dosis 2

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

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

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

Observador ciego

Observer-blind

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Costa Rica

Finland

Germany

Japan

Korea, Democratic People's Republic of

Spain

Taiwan

United States

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 testing results released of samples collected at Visit 3 or Last Subject Last Visit (LSLV) (Follow up contact at month 7-8).

Últimos resultados de las muestras recogidas en visita 3 o última visita del último sujeto (Contacto de seguimiento en el mes 7-8)

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:

1600

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:

1600

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

660

F.4.2.2

In the whole clinical trial

1600

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.

No se planea ningún tratamiento para los sujetos una vez terminado el estudio debido a que la vacuna en estudio es una vacuna profiláctica. Debido a que los sujetos son sanos no ncecesitan ningún tratamiento tras la
finalización del estudio

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

2017-05-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-11-26

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