Clinical Trials Register

Summary
EudraCT Number:	2011-004542-18
Sponsor's Protocol Code Number:	V114-002
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-04-02
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

Denmark - DHMA

A.2

EudraCT number

2011-004542-18

A.3

Full title of the trial

A Multicenter, Double-Blind Study of the Safety, Tolerability, and
Immunogenicity of a Pneumococcal Conjugate Vaccine (V114)
Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX
™ 23) and Prevnar 13™ (Pneumococcal 13-Valent Conjugate
Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults
50 Years of Age or Older

Et dobbeltblindet multicenterforsøg vedrørende sikkerhed, tolerabilitet
og immunogenicitet for en konjugeret polysakkarid pneumokokvaccine
(V114) sammenlignet med en ren polysakkarid pneumokokvaccine
(PNEUMOVAX 23) og Prevenar 13 hos raske voksne i alderen 50 år og
derover

A.3.1

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

Clinical study with a new pneumococcal vaccine (V114) compared with
PNEUMOVAX 23 and Prevnar 13 in healthy adults 50 years of age or
older

Klinisk forsøg med en ny pneumokokvaccine (V114) sammenlignet med
PNEUMOVAX 23 og Prevenar 13 hos raske voksne i alderen 50 år og
derover

A.4.1

Sponsor's protocol code number

V114-002

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01513551

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	Merck Sharp & Dohme Corp.
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.5.2	Functional name of contact point
B.5.3	Address:
B.5.3.1	Street Address	One Merck Drive, PO Box 100
B.5.3.2	Town/ city	Whitehouse Station, NJ
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	1267305-1214
B.5.5	Fax number	1267305-6431

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 Pneumococcal conjugate vaccine, 15-valent
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.3.9.3	Other descriptive name	V114 Pneumococcal Conjugate 15-valent
D.3.10	Strength
D.3.10.1	Concentration unit	mm millimeter(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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: 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	PNEUMOVAX™ 23
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Corp
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	PNEUMOVAX™ 23
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.3.9.3	Other descriptive name	Pneumovax 23
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	.5
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	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	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.3.1	Product name	Prevenar 13
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.3.9.2	Current sponsor code	Prevenar 13
D.3.9.3	Other descriptive name	Prevenar 13
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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

prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, 1, 5, 7F, 3, 6A, 19A, 22F, 33F) in adults.

Forebyggelse af invasiv pneumokok infektion og pneumokok-lungebetændelse forårsaget af S. pneumoniae af serotyperne, der er inkluderet i vaccinen (4, 6B, 9V, 14, 18C, 19F, 1, 5, 7F, 3, 6A, 19A, 22F, 33F) i voksne.

E.1.1.1

Medical condition in easily understood language

pneumococcal disease including pneumococcal sepsis, pneumococcal bacteremia, pneumococcal meningitis, and pneumococcal pneumonia

Pneumokok infektion - inklusiv pneumokok sepsis, pneumokok bakteriæmi, pneumokok meningitis og pneumokok lungebetændelse

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	PT
E.1.2	Classification code	10035728
E.1.2	Term	Pneumonia pneumococcal
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10054047
E.1.2	Term	Pneumococcal sepsis
E.1.2	System Organ Class	10021881 - Infections and infestations

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	10058886
E.1.2	Term	Pneumococcal bacteremia
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10027253
E.1.2	Term	Meningitis pneumococcal
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 demonstrate that the safety profile of a single dose of V114 is acceptable. To compare serotype-specific IgG geometric mean concentrations (GMCs), as measured by Merck’s pneumococcal electrochemiluminescence (Pn ECL) assay between recipients of a single dose of V114 and a single dose of PNEUMOVAX™ 23 for the 14 shared serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F), as measured at 1 month postvaccination.

At vise, at sikkerhedsprofilen for en enkelt dosis af V114 er acceptabel.
At sammenligne serotypespecifikke IgG-geometriske gennemsnitskoncentrationer
(GMC’er), der måles ved hjælp af Pn-ECL-analysen, mellem
recipientet af en enkelt dosis af V114 og en enkelt dosis af
PNEUMOVAX™ 23 for de 14 fælles serotyper (1, 3, 4, 5, 6B, 7F, 9V, 14,
18C, 19F, 19A, 22F, 23F og 33F), målt 1 måned efter vaccination.

E.2.2

Secondary objectives of the trial

Compare functional pneumococcal capsular polysaccharide antibody Geometric Mean Titers (GMTs) by Multiplex Opsonphagocytic (MOPA-4) assay for the 14 serotypes in common between recipients of a single dose of V114 and a single dose of PNEUMOVAX™ 23 at one month postvaccination.

At sammenligne GMT’er ved hjælp af MOPA-4 for de 14 serotyper, der er fælles, mellem recipienter af en enkelt dosis af V114 og en enkelt dosis af PNEUMOVAX™ 23 én måned efter vaccination.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Man or woman in good health.
2. Age ≥50 years.
3. Informed consent signed and dated prior to any study procedures being performed. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in the Future Biomedical Research.
4. Afebrile (<100.4oF [<38.0oC] oral or equivalent) for 72 hours prior to vaccination.
5. Subject is able to read, understand, and complete the study questionnaires (i.e., the VRC).
6. Subject is able to attend all scheduled visits and to comply with the study procedures.
7. Subject is highly unlikely to conceive at any time from signing the informed consent through 6 weeks after receiving the last dose of the study vaccine, as indicated by at least one “yes” answer to the following questions:
a. Subject is male.
b. Subject is a female who agrees to remain abstinent or use (or have her partner use) 2 acceptable methods of contraception during the time period at any time from signing the informed consent through 6 weeks after receiving the study vaccine. Acceptable methods of birth control are: hormonal contraceptives, diaphragm with spermicide, intrauterine device (IUD), contraceptive sponge, condom, or vasectomy. Note that simultaneous use of 2 reliable forms of contraception is recommended.
c. Subject is a female who is not of reproductive potential. A female subject who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (2) post-surgical bilateral oophorectomy and/or hysterectomy, or (3) bilateral tubal ligation.

E.4

Principal exclusion criteria

1. Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine.
2. Known hypersensitivity to any component of the pneumococcal conjugate vaccine or of the pneumococcal polysaccharide vaccine.
3. Known or suspected immunocompromised persons, including persons with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record ≥3 mg/dL), nephrotic syndrome, or other conditions associated with immunosuppression, such as organ or bone marrow transplant.
4. Functional or anatomic asplenia.
5. History of autoimmune disease.
6. Subject has a coagulation disorder contraindicating intramuscular vaccinations.
7. Subject has evidence of dementia or other cognitive impairment.
8. Subject has insufficient muscle mass in the deltoid muscle of either arm or an inability to grade limitation of arm movement as required with postvaccination clinical monitoring.
9. Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Subjects on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 30 days prior to Visit 1 through Visit 2, systemic doses greater than required for physiological replacement, i.e., >20 mg of prednisone (or equivalent) daily and for >2 weeks. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
10. Any underlying illness that would complicate evaluation and completion of this study.
11. Any licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine. (Exception: Inactivated influenza vaccine may be administered during the study but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine.
12. Subject has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine.
13. Subject has received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine.
14. Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
15. Investigational drugs or vaccines received within the 2 months before receipt of study vaccine or is scheduled to receive an investigational drug or vaccines within 30 days of receipt of study vaccine..
16. Subject intends to participate in another interventional clinical study anytime during the duration of the current clinical study (participation in an observational or safety surveillance study is acceptable).
17. History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease.
18. Subject has received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine.
19. Subject is pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
20. Subject resides in a nursing home or long-term care facility or requires semi-skilled nursing care. (A resident of a retirement community who is otherwise ambulatory could be eligible.)
21. Any subject who cannot be adequately followed for safety according to the protocol.
22. Subject is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
23. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

E.5 End points

E.5.1

Primary end point(s)

Ratio of serotype-specific pneumococcal capsular polysaccharide IgG GMCs [V114 / PNEUMOVAX™ 23] in the Pn ECL assay at 1 month postvaccination for 14 common serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F)

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 1 prior to vaccination and Day 30 postvaccination

E.5.2

Secondary end point(s)

Ratio of serotype-specific functional pneumococcal capsular polysaccharide antibody GMTs [V114 / PNEUMOVAX™ 23] in the MOPA-4 assay at 1 month postvaccination for 14 common serotypes ((1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F)

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1 prior to vaccination and Day 30 postvaccination

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

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)

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

Yes

E.8.2.3.1

Comparator description

Prevenar 13™, PNEUMOVAX™ 23

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

Canada

Denmark

Israel

Norway

Poland

Spain

Sweden

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 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

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)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

230

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

460

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

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

332

F.4.2.2

In the whole clinical trial

690

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)

None. Safety issues will be followed for 6 months post-vaccination.

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

2012-04-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-02-15

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