Print
|
Summary
|
|
|---|---|
| EudraCT Number: | 2016-000274-37 |
| Sponsor's Protocol Code Number: | PRI03C |
| National Competent Authority: | Finland - Fimea |
| Clinical Trial Type: | EEA CTA |
| Trial Status: | Completed |
| Date on which this record was first entered in the EudraCT database: | 2016-02-18 |
| Trial results | View results |
Expand All
Collapse All
|
A. Protocol Information
|
|||
|---|---|---|---|
| A.1 | Member State Concerned | Finland - Fimea | |
| A.2 | EudraCT number | 2016-000274-37 | |
| A.3 | Full title of the trial |
|
|
| A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
|
|
| A.4.1 | Sponsor's protocol code number | PRI03C | |
| A.7 | Trial is part of a Paediatric Investigation Plan | No | |
| A.8 | EMA Decision number of Paediatric Investigation Plan | ||
|
B. Sponsor Information
|
||
|---|---|---|
| B.Sponsor: 1 | ||
| B.1.1 | Name of Sponsor | MCM Vaccine B.V. |
| B.1.3.4 | Country | Netherlands |
| 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 | MCM Vaccines B.V. |
| B.4.2 | Country | Netherlands |
| B.5 Contact point designated by the sponsor for further information on the trial | ||
| B.5.1 | Name of organisation | TFS Clinical Operations |
| B.5.2 | Functional name of contact point | Project Manager |
| B.5.3 | Address: | |
| B.5.3.1 | Street Address | Sinikalliontie 3D |
| B.5.3.2 | Town/ city | Espoo |
| B.5.3.3 | Post code | 02630 |
| B.5.3.4 | Country | Finland |
| B.5.4 | Telephone number | +358 (0) 40 838 2365 |
| B.5.6 | leena.kamari@tfscro.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 | Yes |
| D.2.1.1.1 | Trade name | Vaxelis suspension for injection in pre-filled syringe |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Sanofi Pasteur MSD S.N.C. |
| D.2.1.2 | Country which granted the Marketing Authorisation | Finland |
| 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 | Vaxelis |
| D.3.2 | Product code | V419-358 |
| D.3.4 | Pharmaceutical form | Suspension for injection |
| D.3.4.1 | Specific paediatric formulation | Yes |
| 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 | Diphtheria Toxoid |
| D.3.9.3 | Other descriptive name | DIPHTHERIA TOXOID |
| D.3.9.4 | EV Substance Code | SUB12489MIG |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | IU international unit(s) |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 20 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | TETANUS TOXOID |
| D.3.9.3 | Other descriptive name | TETANUS TOXOID |
| D.3.9.4 | EV Substance Code | SUB12608MIG |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | IU international unit(s) |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 40 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | PERTUSSIS TOXOID |
| D.3.9.3 | Other descriptive name | PERTUSSIS TOXOID |
| D.3.9.4 | EV Substance Code | SUB14817MIG |
| 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.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Filamentous Haemagglutinin |
| D.3.9.3 | Other descriptive name | FILAMENTOUS HAEMAGGLUTININ |
| D.3.9.4 | EV Substance Code | SUB38509 |
| 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.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Pertactin |
| D.3.9.3 | Other descriptive name | PERTUSSIS PERTACTIN |
| D.3.9.4 | EV Substance Code | SUB20527 |
| 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 | 3 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Fimbriae Types 2 and 3 |
| D.3.9.3 | Other descriptive name | PERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3 |
| D.3.9.4 | EV Substance Code | SUB25272 |
| 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 | 5 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Hepatitis B Surface Antigen |
| D.3.9.3 | Other descriptive name | HEPATITIS B SURFACE ANTIGEN (RDNA) |
| D.3.9.4 | EV Substance Code | SUB20082 |
| 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 | 10 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Inactivated Type 1 poliovirus (Mahoney) |
| D.3.9.3 | Other descriptive name | POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) |
| D.3.9.4 | EV Substance Code | SUB25292 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | DAgU D antigen unit(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 40 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Inactivated Type 2 poliovirus (MEF1) |
| D.3.9.3 | Other descriptive name | POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) |
| D.3.9.4 | EV Substance Code | SUB25266 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | DAgU D antigen unit(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 8 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Inactivated Type 3 poliovirus (Saukett) |
| D.3.9.3 | Other descriptive name | POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) |
| D.3.9.4 | EV Substance Code | SUB25264 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | DAgU D antigen unit(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 32 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Hib conjugate to meningococcal outer membrane protein complex |
| D.3.9.3 | Other descriptive name | HAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO NEISSERIA MENINGITIDIS (B11 STRAIN) OUTER MEMBRANE PROTEIN COMPLEX (OMPC) |
| D.3.9.4 | EV Substance Code | SUB25334 |
| 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 | 3 |
| 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 | Infanrix hexa |
| 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 | Finland |
| 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 | Infanrix hexa |
| D.3.4 | Pharmaceutical form | Powder and suspension for suspension for injection |
| D.3.4.1 | Specific paediatric formulation | Yes |
| 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 | Diphtheria Toxoid |
| D.3.9.3 | Other descriptive name | DIPHTHERIA TOXOID |
| D.3.9.4 | EV Substance Code | SUB12489MIG |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | IU international unit(s) |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 30 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | TETANUS TOXOID |
| D.3.9.3 | Other descriptive name | TETANUS TOXOID |
| D.3.9.4 | EV Substance Code | SUB12608MIG |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | IU international unit(s) |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 40 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | PERTUSSIS TOXOID |
| D.3.9.3 | Other descriptive name | PERTUSSIS TOXOID |
| D.3.9.4 | EV Substance Code | SUB14817MIG |
| 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 | 25 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Filamentous Haemagglutinin |
| D.3.9.3 | Other descriptive name | FILAMENTOUS HAEMAGGLUTININ |
| D.3.9.4 | EV Substance Code | SUB38509 |
| 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 | 25 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Pertactin |
| D.3.9.3 | Other descriptive name | PERTUSSIS PERTACTIN |
| D.3.9.4 | EV Substance Code | SUB20527 |
| 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 | 8 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Hepatitis B Surface Antigen |
| D.3.9.3 | Other descriptive name | HEPATITIS B SURFACE ANTIGEN |
| D.3.9.4 | EV Substance Code | SUB14083MIG |
| 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 | 10 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Inactivated Type 1 poliovirus (Mahoney) |
| D.3.9.3 | Other descriptive name | POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) |
| D.3.9.4 | EV Substance Code | SUB25292 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | DAgU D antigen unit(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 40 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Inactivated Type 2 poliovirus (MEF1) |
| D.3.9.3 | Other descriptive name | POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) |
| D.3.9.4 | EV Substance Code | SUB25266 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | DAgU D antigen unit(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 8 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Inactivated Type 3 poliovirus (Saukett) |
| D.3.9.3 | Other descriptive name | POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) |
| D.3.9.4 | EV Substance Code | SUB25264 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | DAgU D antigen unit(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 32 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) |
| D.3.9.3 | Other descriptive name | HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) |
| D.3.9.4 | EV Substance Code | SUB14050MIG |
| 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 | 10 |
| 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.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 |
|
|||||||||||||||
| E.1.1.1 | Medical condition in easily understood language |
|
|||||||||||||||
| E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] | |||||||||||||||
| MedDRA Classification | |||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
|
|||||||||||||||||
| E.1.3 | Condition being studied is a rare disease | No | |||||||||||||||
| E.2 Objective of the trial | |||||||||||||||||
| E.2.1 | Main objective of the trial |
|
|||||||||||||||
| E.2.2 | Secondary objectives of the trial |
|
|||||||||||||||
| E.2.3 | Trial contains a sub-study | No | |||||||||||||||
| E.3 | Principal inclusion criteria |
|
|||||||||||||||
| E.4 | Principal exclusion criteria |
|
|||||||||||||||
| E.5 End points | |||||||||||||||||
| E.5.1 | Primary end point(s) |
|
|||||||||||||||
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
|||||||||||||||
| E.5.2 | Secondary end point(s) |
|
|||||||||||||||
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
|||||||||||||||
| E.6 and E.7 Scope of the trial | |||||||||||||||||
| E.6 | Scope of the trial | ||||||||||||||||
| E.6.1 | Diagnosis | No | |||||||||||||||
| E.6.2 | Prophylaxis | No | |||||||||||||||
| E.6.3 | Therapy | No | |||||||||||||||
| E.6.4 | Safety | No | |||||||||||||||
| E.6.5 | Efficacy | Yes | |||||||||||||||
| E.6.6 | Pharmacokinetic | No | |||||||||||||||
| E.6.7 | Pharmacodynamic | No | |||||||||||||||
| E.6.8 | Bioequivalence | No | |||||||||||||||
| E.6.9 | Dose response | No | |||||||||||||||
| E.6.10 | Pharmacogenetic | No | |||||||||||||||
| E.6.11 | Pharmacogenomic | No | |||||||||||||||
| E.6.12 | Pharmacoeconomic | No | |||||||||||||||
| E.6.13 | Others | Yes | |||||||||||||||
| E.6.13.1 | Other scope of the trial description |
|
|||||||||||||||
| E.7 | Trial type and phase | ||||||||||||||||
| E.7.1 | Human pharmacology (Phase I) | No | |||||||||||||||
| E.7.1.1 | First administration to humans | No | |||||||||||||||
| E.7.1.2 | Bioequivalence study | No | |||||||||||||||
| E.7.1.3 | Other | No | |||||||||||||||
| E.7.1.3.1 | Other trial type description | ||||||||||||||||
| E.7.2 | Therapeutic exploratory (Phase II) | No | |||||||||||||||
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes | |||||||||||||||
| E.7.4 | Therapeutic use (Phase IV) | No | |||||||||||||||
| E.8 Design of the trial | |||||||||||||||||
| E.8.1 | Controlled | Yes | |||||||||||||||
| E.8.1.1 | Randomised | No | |||||||||||||||
| E.8.1.2 | Open | Yes | |||||||||||||||
| E.8.1.3 | Single blind | No | |||||||||||||||
| E.8.1.4 | Double blind | No | |||||||||||||||
| E.8.1.5 | Parallel group | Yes | |||||||||||||||
| E.8.1.6 | Cross over | No | |||||||||||||||
| E.8.1.7 | Other | Yes | |||||||||||||||
| E.8.1.7.1 | Other trial design description |
|
|||||||||||||||
| E.8.2 | Comparator of controlled trial | ||||||||||||||||
| E.8.2.1 | Other medicinal product(s) | Yes | |||||||||||||||
| E.8.2.2 | Placebo | No | |||||||||||||||
| E.8.2.3 | Other | No | |||||||||||||||
| E.8.2.4 | Number of treatment arms in the trial | 4 | |||||||||||||||
| E.8.3 | The trial involves single site in the Member State concerned | No | |||||||||||||||
| 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 | 10 | |||||||||||||||
| E.8.5 | The trial involves multiple Member States | No | |||||||||||||||
| E.8.6 Trial involving sites outside the EEA | |||||||||||||||||
| E.8.6.1 | Trial being conducted both within and outside the EEA | No | |||||||||||||||
| E.8.6.2 | Trial being conducted completely outside of the EEA | No | |||||||||||||||
| E.8.7 | Trial has a data monitoring committee | No | |||||||||||||||
| 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 | 6 | |||||||||||||||
| E.8.9.1 | In the Member State concerned days | ||||||||||||||||
| E.8.9.2 | In all countries concerned by the trial months | 6 | |||||||||||||||
|
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: | 760 | |
| F.1.1.1 | In Utero | No | |
| F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No | |
| F.1.1.3 | Newborns (0-27 days) | No | |
| F.1.1.4 | Infants and toddlers (28 days-23 months) | No | |
| F.1.1.5 | Children (2-11years) | Yes | |
| F.1.1.5.1 | Number of subjects for this age range: | 760 | |
| F.1.1.6 | Adolescents (12-17 years) | No | |
| F.1.2 | Adults (18-64 years) | No | |
| F.1.3 | Elderly (>=65 years) | No | |
| 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 | No | |
| F.3.3 | Specific vulnerable populations | Yes | |
| F.3.3.1 | Women of childbearing potential not using contraception | No | |
| F.3.3.2 | Women of child-bearing potential using contraception | No | |
| F.3.3.3 | Pregnant women | No | |
| F.3.3.4 | Nursing women | No | |
| F.3.3.5 | Emergency situation | No | |
| F.3.3.6 | Subjects incapable of giving consent personally | No | |
| F.3.3.7 | Others | Yes | |
| F.3.3.7.1 | Details of other specific vulnerable populations |
|
|
| F.4 Planned number of subjects to be included | |||
| F.4.1 | In the member state | 760 | |
| F.4.2 | For a multinational trial | ||
| F.4.2.1 | In the EEA | 760 | |
| F.4.2.2 | In the whole clinical trial | 760 | |
| 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) |
|
|
|
G. Investigator Networks to be involved in the Trial
|
|---|
|
N. Review by the Competent Authority or Ethics Committee in the country concerned
|
||
|---|---|---|
| N. | Competent Authority Decision | Authorised |
| N. | Date of Competent Authority Decision | 2016-03-21 |
| N. | Ethics Committee Opinion of the trial application | Favourable |
| N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
|
| N. | Date of Ethics Committee Opinion | 2016-03-18 |
|
P. End of Trial
|
||
|---|---|---|
| P. | End of Trial Status | Completed |
| P. | Date of the global end of the trial | 2017-04-05 |
