Clinical Trials Register

Summary
EudraCT Number:	2009-017332-41
Sponsor's Protocol Code Number:	6096A1-4001-EU
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:	2010-05-19
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

2009-017332-41

A.3

Full title of the trial

A Phase 4, Open-label Trial Describing the Safety, Tolerability, and Immunogenicity of the 13 valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants
Ensayo de Fase 4, abierto, para descripción de la seguridad, la tolerabilidad y la capacidad inmunógena de la vacuna antineumocócica conjugada tridecavalente en lactantes prematuros en comparación con lactantes nacidos a término

A.4.1

Sponsor's protocol code number

6096A1-4001-EU

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	Wyeth LLC
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	Yes
D.2.1.1.1	Trade name	PREVENAR 13 suspensión inyectable
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	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	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	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 1
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 1
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 14
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 14
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 18C
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 18C
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 19A
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 19A
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 19F
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 19F
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 23F
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 23F
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 3
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 3
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 4
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 4
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 5
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 5
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 6A
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 6A
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 6B
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 6B
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	8.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 7F
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 7F
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 9V
D.3.9.3	Other descriptive name	NEUMOCOCO ANTIGENO POLISACARIDO CAPSULAR SEROTIPO 9V
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	4.4
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

Pneumococcal infection
Infección neumocócica.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10061353
E.1.2	Term	Pneumococcal infection

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 describe the pneumococcal immune response induced by 13vPnC when measured 1 month after the infant series in preterm infants compared to term infants (>= 37 weeks of gestation).
Describir la respuesta inmunitaria frente al neumococo inducida por 13vPnC en su medición 1 mes después de la serie de dosis del lactante en prematuros en comparación con nacidos a término (>= 37 semanas de gestación).

E.2.2

Secondary objectives of the trial

To describe the pneumococcal immune response induced by 13vPnC when measured 1 month after the toddler dose in preterm infants compared to term infants (>= 37 weeks of gestation).
Describir la respuesta inmunitaria frente al neumococo inducida por 13vPnC en su medición 1 mes después de la dosis del niño de corta edad en prematuros en comparación con nacidos a término (>= 37 semanas de gestación).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Grupo 1, Lactantes prematuros:
1. Lactantes de ambos sexos nacidos con < 37 semanas de gestación (la EG será determinada por el investigador).
2. Edad cronológica >= 42 a <= 98 días (aproximadamente 2 meses) en el momento del reclutamiento en el estudio.
3. Por lo demás, prematuro sano de acuerdo con su historia médica, exploración física y criterio del investigador.
4. Progenitor/tutor legal disponible para completar todos los procedimientos relevantes del estudio durante la participación en el estudio.
5. Disponibilidad durante todo el periodo del estudio y con cuyo progenitor/tutor legal puede contactarse por teléfono.

Grupo 2, Lactantes nacidos a término:
1. Lactantes de ambos sexos nacidos con >= 37 semanas de gestación (la EG será determinada por el investigador).
2. Edad cronológica >= 42 a >= 98 días (aproximadamente 2 meses) en el momento del reclutamiento en el estudio.
3. Lactante sano de acuerdo con su historia médica, exploración física y criterio del investigador.
4. Progenitor/tutor legal disponible para completar todos los procedimientos relevantes del estudio durante la participación en el estudio.
5. Disponibilidad durante todo el periodo del estudio y con cuyo progenitor/tutor legal puede contactarse por teléfono.

E.4

Principal exclusion criteria

1. Vacunación previa con una vacuna, aprobada o en fase de investigación, antineumocócica, vacuna conjugada frente al Hib, vacuna conjugada frente al meningococo de tipo C, o vacuna frente a difteria, tétanos, tosferina o poliovirus.
2. Reacción anafiláctica previa o alergia a cualquier vacuna o componente de una vacuna.
3. Contraindicación a la vacunación con cualquier vacuna pediátrica habitual.
4. Diátesis hemorrágica o proceso asociado con un tiempo de hemorragia prolongado que pueda contraindicar la inyección intramuscular.
5. Antecedentes de enfermedad invasiva por S. pneumoniae, demostrado por cultivo.
6. Conocimiento o sospecha de deficiencia o supresión inmunitaria.
7. Malformación congénita de carácter mayor o enfermedad crónica grave conocidas.
8. Enfermedad neurológica importante o antecedentes de convulsiones, incluidas las convulsiones febriles, o proceso importante, ya sea estable o en evolución, como parálisis cerebral, encefalopatía, hidrocefalia u otra enfermedad importante.
9. Recepción de cualquier otra vacuna, fármaco o producto sanitario en fase de investigación en el plazo de los 28 días previos a la inclusión y a la primera vacunación del estudio.
10. Lactante que es descendiente directo (por ejemplo, hijo o nieto) de personal del estudio.
11. Enfermedad o proceso de carácter mayor que, en opinión del investigador, pudiera aumentar sustancialmente el riesgo derivado de la participación del sujeto en el estudio y de su compleción o que pudiera impedir la evaluación de la respuesta del sujeto.

E.5 End points

E.5.1

Primary end point(s)

En cada uno de los serotipos de neumococo, la variable principal será el porcentaje de sujetos que alcancen una concentración de IgG específicas del serotipo >= 0,35 μg/mL medida 1 mes después de la serie de dosis del lactante.

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Information not present in EudraCT

E.8.1.2

Open

Information not present in EudraCT

E.8.1.3

Single blind

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Information not present in EudraCT

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

Information not present in EudraCT

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

Information not present in EudraCT

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

End fo the trial is defined in section 11.3 of the protocol: "Approximate Duration of Study"
El final del estudio se define en la sección 11.3 del protocolo: "Duración Aproximada 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

Yes

F.1.1.1

In Utero

F.1.1.2

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

Yes

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.5

Children (2-11years)

Yes

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

Preterm newborn infants

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

200

F.4.2.2

In the whole clinical trial

200

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

2010-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-07-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-23

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