Clinical Trials Register

Summary
EudraCT Number:	2010-019775-29
Sponsor's Protocol Code Number:	V114-003
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-07-29
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

2010-019775-29

A.3

Full title of the trial

"Estudio multicéntrico y doble ciego de la seguridad, la tolerabilidad y la inmunogenicidad de una vacuna antineumocócica conjugada (V114) en comparación con Prevenar 13™ en lactantes sanos";"A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants"

A.4.1

Sponsor's protocol code number

V114-003

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	V114 adjuvanted Pneumococcal 15-valent Conjugate Vaccine (Diphtheria CRM 197 Protein)
D.3.2	Product code	V114
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pnp Serotipos 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F ,CRM197 (carrier protein)
D.3.9.2	Current sponsor code	V114
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	64
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Prevenar 13
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	Belgium
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	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, CRM197 (carrier protein)
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	61.6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	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	V114 non-adjuvanted Pneumococcal 15-valent Conjugate Vaccine (Diphtheria CRM 197 Protein)
D.3.2	Product code	V114- sin adjuvante
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pnp Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, CRM197 (carrier protein)
D.3.9.2	Current sponsor code	V114
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	64
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prevención de la enfermedad invasiva neumocócica, la neumonía neumocócica y la otitis media causada por S. pneumoniae, debido a los serotipos capsulares incluidos en la vacuna (4, 6B,9V,14,18C,19F,1,5,7F,3,6A,19A,22F,33F) en lactantes y niños pequeños

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13
E.1.2	Level	LLT
E.1.2	Classification code	10054047
E.1.2	Term	Sepsis neumocócica

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13
E.1.2	Level	LLT
E.1.2	Classification code	10058886
E.1.2	Term	Bacteriemia por neumococo

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13
E.1.2	Level	LLT
E.1.2	Classification code	10027253
E.1.2	Term	Meningitis neumocócica

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13
E.1.2	Level	LLT
E.1.2	Classification code	10035647
E.1.2	Term	Neumonía neumocócica

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13
E.1.2	Level	LLT
E.1.2	Classification code	10033078
E.1.2	Term	Otitis media

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

(1) Objetivo: demostrar que la vacuna antineumocócica conjugada 15 valente (V114) con aluminio como adyuvante o V114 sin adyuvante no es inferior a la vacuna antineumocócica conjugada 13 valente (Prevenar 13™) en cuanto a los 7 serotipos compartidos con Prevenar™ (serotipos 4, 6B, 9V, 14, 18C, 19F, 23F), según la proporción de sujetos que alcancen las concentraciones de referencia de IgG específica de cada serotipo después de la dosis 3.
(2) Objetivo: describir el perfil de seguridad de una serie de 3 dosis de vacuna antineumocócica conjugada 15 valente (V114) con y sin aluminio como adyuvante en comparación con la vacuna antineumocócica conjugada 13 valente (Prevenar 13™) administrada a lactantes sanos a los 2, 4 y 6 meses de edad.

E.2.2

Secondary objectives of the trial

(1) Objetivo: demostrar que la vacuna antineumocócica conjugada 15 valente (V114) con aluminio como adyuvante o V114 sin aluminio como adyuvante no es inferior a la vacuna antineumocócica conjugada 13 valente (Prevenar 13™) en cuanto a los 6 serotipos compartidos con Prevenar 13™ pero no con Prevenar™ (serotipos 1, 3, 5, 6A, 7F, 19A), según la proporción de sujetos que alcancen las concentraciones de referencia de IgG después de la dosis 3.
(2) Objetivo: demostrar que la vacuna antineumocócica conjugada 15 valente (V114) con o sin aluminio como adyuvante es más inmunógena que la vacuna antineumocócica conjugada 13 valente (Prevenar 13™) en cuanto a los dos serotipos no compartidos con Prevenar 13™ (serotipos 22F y 33F), según la proporción de sujetos que alcancen la concentración de referencia de IgG después de la dosis 3.
(3) Objetivo: describir el perfil de seguridad de una cuarta dosis de las formulaciones de la vacuna antineumocócica conjugada 15 valente (V114) con y sin aluminio

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Se va a realizar una investigación genética y biomédica de otro tipo con las muestras que queden una vez finalizado el estudio principal. Dicha investigación genética y biomédica de otro tipo podría incluir análisis genéticos (ADN), determinación de perfiles de expresión génica (ARN), proteómica, metabolómica (suero, plasma) o determinación de otros elementos. El objetivo de la obtención de muestras para investigaciones futuras es explorar e identificar biomarcadores que amplíen el conocimiento.

E.3

Principal inclusion criteria

Se considerará que un sujeto es apto para participar en este estudio si cumple todos los criterios siguientes:
a. Lactantes sanos, edad > ó = 6 a < ó = 12 semana ( >ó= 42 a < ó= 89 días).
b. El progenitor/tutor del sujeto comprende los procedimientos del estudio, los tratamientos alternativos disponibles y los riesgos asociados, y acepta voluntariamente participar en él dando su consentimiento informado por escrito.
c. Afebril, con una temperatura rectal < 38,1° C o una temperatura axilar < 37,8° C el día de la vacunación.
d. El progenitor/tutor del sujeto es capaz de leer, comprender y responder a los cuestionarios del estudio (es decir, la tarjeta de vacunación).
e. El sujeto puede acudir a todas las visitas programadas y cumplir los procedimientos del estudio.
f. El progenitor/tutor del sujeto tiene acceso a un teléfono.

E.4

Principal exclusion criteria

Se considerará que un sujeto no es apto para participar en este estudio si cumple alguno de los criterios siguientes:
a. Administración previa de cualquier vacuna antineumocócica.
b. Hipersensibilidad conocida a cualquier componente de la vacuna antineumocócica conjugada.
c. Sospecha o certeza de deterioro de la función inmunológica.
d. El sujeto tiene antecedentes de inmunodeficiencia congénita o adquirida (por ejemplo, esplenomegalia).
e. El sujeto o su madre tiene una infección por el VIH documentada.
f. Asplenia funcional o anatómica.
g. Antecedentes de enfermedad autoinmunitaria como esclerosis múltiple (EM), lupus sistémico, polimiositis, miositis con cuerpos de inclusión, dermatomiositis, tiroiditis de Hashimoto, síndrome de Sjogren, artritis reumatoide u otros trastornos autoinmunitarios.
h. Trastornos neurológicos o cognitivo conductuales conocidos como esclerosis múltiple (EM), enfermedad de tipo EM, encefalitis/mielitis, encefalomielitis diseminada aguda, trastorno generalizado del desarrollo y trastornos relacionados.
i. Uso de cualquier tratamiento inmunodepresor (Nota: se permitirán los esteroides tópicos e inhalados/nebulizados). Se excluirá a los sujetos en tratamiento con corticoides por vía intramuscular, oral o intravenosa en caso de recibir o tener previsto recibir, en el período comprendido entre 30 días antes de la visita 1 y la visita 6 (30 días DD4), más de 2 mg/kg al día de prednisona (o equivalente), o con más de 20 mg al día si pesan más de 10 kg y no están inmunodeprimidos por lo demás. Entre los tratamientos inmunodepresores excluidos figuran también los quimioterápicos contra el cáncer u otras enfermedades y los tratamientos asociados al trasplante de órganos o de médula ósea o enfermedades autoinmunitarias.
j. El sujeto ha recibido otras vacunas inactivadas autorizadas en los 14 días anteriores a la administración de la vacuna del estudio.
k. El sujeto ha recibido una vacuna de virus vivos autorizada en los 30 días anteriores a la administración de la vacuna del estudio.
l. Recepción previa de una transfusión de sangre o hemoderivados, incluidas inmunoglobulinas.
m. Recepción de fármacos o vacunas en fase de investigación en los 2 meses anteriores a la administración de la vacuna del estudio.
n. Participación en otro estudio clínico en los 42 días anteriores al inicio o en cualquier momento durante el presente estudio clínico.
o. Antecedentes de enfermedad neumocócica invasora (hemocultivo positivo, cultivo positivo de líquido cefalorraquídeo u otro sitio estéril) o de cualquier otra enfermedad neumocócica con cultivo positivo.
p. Enfermedad febril reciente (temperatura rectal > ó = 38,1° C) que aparece en las 72 horas anteriores a la administración de la vacuna del estudio.
q. Antecedentes de retraso del crecimiento.
r. El sujeto tiene un trastorno de la coagulación que contraindica la vacunación IM.
s. El sujeto y su madre tienen un antígeno de superficie del virus de la hepatitis B positivo documentado.
t. Lactantes que no pueden ser vigilados debidamente en cuanto a seguridad de acuerdo con el plan del protocolo.
u. Es poco probable que el progenitor/tutor del sujeto cumpla los procedimientos del estudio o que acuda a las citas, o tiene previsto mudarse durante el estudio.
v. Cualquier otro motivo que, en opinión del investigador, podría interferir en la evaluación exigida por el estudio.

E.5 End points

E.5.1

Primary end point(s)

Proporción de sujetos que alcancen la concentración definida después de la dosis 3, en relación con cada uno de los 7 serotipos compartidos entre V114 y Prevenar™.

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Inmunogenicidad

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Niños en fase de Lactancia

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

677

F.4.2.2

In the whole clinical trial

1110

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-09-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-08-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-07-31

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