Summary
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EudraCT Number: | 2021-001200-15 |
Sponsor's Protocol Code Number: | ALXN1210-DM-310 |
National Competent Authority: | Italy - Italian Medicines Agency |
Clinical Trial Type: | EEA CTA |
Trial Status: | Prematurely Ended |
Date on which this record was first entered in the EudraCT database: | 2021-10-18 |
Trial results | View results |
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A. Protocol Information
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A.1 | Member State Concerned | Italy - Italian Medicines Agency | ||
A.2 | EudraCT number | 2021-001200-15 | ||
A.3 | Full title of the trial |
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A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
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A.3.2 | Name or abbreviated title of the trial where available |
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A.4.1 | Sponsor's protocol code number | ALXN1210-DM-310 | ||
A.7 | Trial is part of a Paediatric Investigation Plan | No | ||
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
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B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | ALEXION PHARMACEUTICALS INCORPORATED |
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 | Alexion Pharmaceuticals, 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 | Alexion Europe SAS |
B.5.2 | Functional name of contact point | European Clinical Trial Information |
B.5.3 | Address: | |
B.5.3.1 | Street Address | 103-105 rue Anatole France |
B.5.3.2 | Town/ city | Levallois-Perret |
B.5.3.3 | Post code | 92300 |
B.5.3.4 | Country | France |
B.5.4 | Telephone number | +33147100615 |
B.5.5 | Fax number | +33147100611 |
B.5.6 | clinicaltrials.eu@alexion.com |
D. IMP Identification
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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 | Ultomiris |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Alexion Europe SAS |
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 | Ravulizumab |
D.3.2 | Product code | [ALXN1210] |
D.3.4 | Pharmaceutical form | Concentrate for solution for injection/infusion |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RAVULIZUMAB |
D.3.9.1 | CAS number | 1803171-55-2 |
D.3.9.2 | Current sponsor code | RAVULIZUMAB |
D.3.9.3 | Other descriptive name | ALXN1210 |
D.3.9.4 | EV Substance Code | SUB172162 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
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 | 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 | Ultomiris |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Alexion Europe SAS |
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 | Ravulizumab |
D.3.2 | Product code | [ALXN1210] |
D.3.4 | Pharmaceutical form | Concentrate for solution for injection/infusion |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intravenous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RAVULIZUMAB |
D.3.9.1 | CAS number | 1803171-55-2 |
D.3.9.2 | Current sponsor code | RAVULIZUMAB |
D.3.9.3 | Other descriptive name | ALXN1210 |
D.3.9.4 | EV Substance Code | SUB172162 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 100 |
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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
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 | 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 | Nimenrix |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Pfizer Europe MA EEIG EU/1/12/767/001-004 |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
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 | Nimenrix |
D.3.2 | Product code | [NA] |
D.3.4 | Pharmaceutical form | Powder and solvent for solution for injection in pre-filled syringe |
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.3.8 | INN - Proposed INN | tetanus protein |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | tetanus protein |
D.3.9.4 | EV Substance Code | SUB35034 |
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 | 44 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED WITH TETANUS TOXOID CARRIER PROTEIN |
D.3.9.2 | Current sponsor code | na |
D.3.9.3 | Other descriptive name | NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED WITH TETANUS TOXOID CARRIER PROTEIN |
D.3.9.4 | EV Substance Code | SUB36479 |
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 | NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN |
D.3.9.4 | EV Substance Code | SUB36481 |
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 | NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN |
D.3.9.4 | EV Substance Code | SUB36482 |
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 | NEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT) |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | NEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT) |
D.3.9.4 | EV Substance Code | SUB31471 |
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.3.11 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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | 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: 4 | ||
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 | Bexsero |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy EU/1/12/812/001-004 |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
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 | Bexsero |
D.3.2 | Product code | [/] |
D.3.4 | Pharmaceutical form | Solution for injection/infusion in pre-filled syringe |
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.3.8 | INN - Proposed INN | Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 |
D.3.9.2 | Current sponsor code | na |
D.3.9.3 | Other descriptive name | RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE |
D.3.9.4 | EV Substance Code | SUB96090 |
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 | RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN |
D.3.9.4 | EV Substance Code | SUB191635 |
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 | 50 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN |
D.3.9.4 | EV Substance Code | SUB191633 |
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 | 50 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN |
D.3.9.4 | EV Substance Code | SUB191634 |
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 | 50 |
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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | 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: 5 | ||
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 | Velamox |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Neopharmed Gentili S.p.A., Italy 023097013 |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
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 | Velamox |
D.3.2 | Product code | [NA] |
D.3.4 | Pharmaceutical form | Capsule, hard |
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 | Amoxicilline |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | AMOXICILLIN TRIHYDRATE |
D.3.9.4 | EV Substance Code | SUB00504MIG |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 500 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
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: 6 | ||
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 | Menveo |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GSK Vaccines S.r.l. Italy EU/1/10/614-002-003 |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
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 | Menveo |
D.3.2 | Product code | [NA] |
D.3.4 | Pharmaceutical form | Powder and solvent for solution 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.3.8 | INN - Proposed INN | MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN |
D.3.9.4 | EV Substance Code | SUB77061 |
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 | N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 ADSORBED ON ALUMINUM HYDROXIDE |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 ADSORBED ON ALUMINUM HYDROXIDE |
D.3.9.4 | EV Substance Code | SUB194220 |
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 | MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN |
D.3.9.4 | EV Substance Code | SUB77063 |
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 | MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN |
D.3.9.4 | EV Substance Code | SUB77060 |
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.3.11 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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | 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: 7 | ||
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 | Trumenba |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Pfizer Europe MA EEIG, Belgium EU/1/17/1187/001-006 |
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 | Trumenba |
D.3.2 | Product code | [NA] |
D.3.4 | Pharmaceutical form | Powder and solvent for solution for injection in pre-filled syringe |
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.3.8 | INN - Proposed INN | NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY A |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY A |
D.3.9.4 | EV Substance Code | SUB182443 |
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 | 60 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY B |
D.3.9.2 | Current sponsor code | NA |
D.3.9.3 | Other descriptive name | NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY B |
D.3.9.4 | EV Substance Code | SUB182444 |
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 | 60 |
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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | 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
|
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D.8 Placebo: 1 | ||
D.8.1 | Is a Placebo used in this Trial? | Yes |
D.8.3 | Pharmaceutical form of the placebo | Concentrate for solution for injection/infusion |
D.8.4 | Route of administration of the placebo | Intravenous use |
E. General Information on the Trial
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E.1 Medical condition or disease under investigation | ||||||||||
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] | ||||||||
MedDRA Classification | ||||||||||
E.1.3 | Condition being studied is a rare disease | Yes | ||||||||
E.2 Objective of the trial | ||||||||||
E.2.1 | Main objective of the trial |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No | ||||||||
E.3 | Principal inclusion criteria |
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E.4 | Principal exclusion criteria |
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E.5 End points | ||||||||||
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes | ||||||||
E.6.4 | Safety | Yes | ||||||||
E.6.5 | Efficacy | Yes | ||||||||
E.6.6 | Pharmacokinetic | Yes | ||||||||
E.6.7 | Pharmacodynamic | Yes | ||||||||
E.6.8 | Bioequivalence | No | ||||||||
E.6.9 | Dose response | Yes | ||||||||
E.6.10 | Pharmacogenetic | No | ||||||||
E.6.11 | Pharmacogenomic | No | ||||||||
E.6.12 | Pharmacoeconomic | No | ||||||||
E.6.13 | Others | No | ||||||||
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) | Yes | ||||||||
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 | Yes | ||||||||
E.8.1.2 | Open | No | ||||||||
E.8.1.3 | Single blind | No | ||||||||
E.8.1.4 | Double blind | Yes | ||||||||
E.8.1.5 | Parallel group | Yes | ||||||||
E.8.1.6 | Cross over | No | ||||||||
E.8.1.7 | Other | No | ||||||||
E.8.2 | Comparator of controlled trial | |||||||||
E.8.2.1 | Other medicinal product(s) | No | ||||||||
E.8.2.2 | Placebo | Yes | ||||||||
E.8.2.3 | Other | No | ||||||||
E.8.2.4 | Number of treatment arms in the trial | 2 | ||||||||
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 | 5 | ||||||||
E.8.5 | The trial involves multiple Member States | Yes | ||||||||
E.8.5.1 | Number of sites anticipated in the EEA | 19 | ||||||||
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 |
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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 | 4 | ||||||||
E.8.9.1 | In the Member State concerned months | 11 | ||||||||
E.8.9.1 | In the Member State concerned days | 6 | ||||||||
E.8.9.2 | In all countries concerned by the trial years | 4 | ||||||||
E.8.9.2 | In all countries concerned by the trial months | 11 | ||||||||
E.8.9.2 | In all countries concerned by the trial days | 6 |
F. Population of Trial Subjects
|
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F.1 Age Range | ||||
F.1.1 | Trial has subjects under 18 | No | ||
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) | No | ||
F.1.1.6 | Adolescents (12-17 years) | No | ||
F.1.2 | Adults (18-64 years) | Yes | ||
F.1.2.1 | Number of subjects for this age range: | 180 | ||
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 | No | ||
F.3.2 | Patients | Yes | ||
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 | Yes | ||
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 | No | ||
F.4 Planned number of subjects to be included | ||||
F.4.1 | In the member state | 8 | ||
F.4.2 | For a multinational trial | |||
F.4.2.1 | In the EEA | 61 | ||
F.4.2.2 | In the whole clinical trial | 180 | ||
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
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N. Review by the Competent Authority or Ethics Committee in the country concerned
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N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2021-08-16 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
|
N. | Date of Ethics Committee Opinion | 2021-07-28 |
P. End of Trial
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---|---|---|
P. | End of Trial Status | Prematurely Ended |
P. | Date of the global end of the trial | 2023-12-18 |