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 | Fluarix Quadrivalent |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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 | quadrivalent seasonal influenza vaccine (Flu D-QIV) |
D.3.2 | Product code | GSK2321138A |
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.3.8 | INN - Proposed INN | A/CALIFORNIA/7/2009 (H1N1)-like virus:A/Christchurch/16/2010 NIB-74xp |
D.3.9.3 | Other descriptive name | A/CALIFORNIA/7/2009 (H1N1)-like virus:A/Christchurch/16/2010 NIB-74xp |
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 | 15 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | A/Victoria/361/2011 (H3N2)-lire virus:A/Victoria/361/2011 IVR-165 |
D.3.9.3 | Other descriptive name | A/Victoria/361/2011 (H3N2)-lire virus:A/Victoria/361/2011 IVR-165 |
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 | 15 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | B/Wisconsin/1/2010 (Yamagata-lineage)-like virus:B/Hubei-Wujiagang/158/2009 NYMC BX-39 |
D.3.9.3 | Other descriptive name | B/Wisconsin/1/2010 (Yamagata-lineage)-like virus:B/Hubei-Wujiagang/158/2009 NYMC BX-39 |
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 | 15 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | B/BRISBANE/60/2008 (Victoria-lineage)-LIKE VIRUS: B/Brisbane/60/2008 |
D.3.9.3 | Other descriptive name | B/BRISBANE/60/2008 (Victoria-lineage)-LIKE VIRUS: B/Brisbane/60/2008 |
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 | 15 |
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.IMP: 2 |
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Prevenar 13 |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Wyeth |
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.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 |
D.3.9.4 | EV Substance Code | SUB30927 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 |
D.3.9.4 | EV Substance Code | SUB30925 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 |
D.3.9.4 | EV Substance Code | SUB30926 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 |
D.3.9.4 | EV Substance Code | SUB25336 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 |
D.3.9.4 | EV Substance Code | SUB30928 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25344 |
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 | 4.4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 |
D.3.9.4 | EV Substance Code | SUB30929 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25342 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25340 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C |
D.3.9.4 | EV Substance Code | SUB20580 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 |
D.3.9.4 | EV Substance Code | SUB30930 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25366 |
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 | 2.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE |
D.3.9.4 | EV Substance Code | SUB25347 |
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 | 2.2 |
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.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 | Varivax/ProVarivax |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Sanofi Pasteur MSD |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Varivax/ProVarivax |
D.3.4 | Pharmaceutical form | Powder and solvent for 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.3.8 | INN - Proposed INN | VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS |
D.3.9.3 | Other descriptive name | VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS |
D.3.9.4 | EV Substance Code | SUB25312 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | PFU/dose plaque forming unit(s)/dose |
D.3.10.2 | Concentration type | not less then |
D.3.10.3 | Concentration number | 1350 |
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.IMP: 4 |
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 | Varilrix |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline |
D.2.1.2 | Country which granted the Marketing Authorisation | Belgium |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP |
D.3.1 | Product name | Varilrix |
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 | Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | VARICELLA VIRUS |
D.3.9.3 | Other descriptive name | VARICELLA VIRUS |
D.3.9.4 | EV Substance Code | SUB20954 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | PFU/dose plaque forming unit(s)/dose |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1995.26 |
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.IMP: 5 |
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 | Havrix Junior |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline |
D.2.1.2 | Country which granted the Marketing Authorisation | Belgium |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP |
D.3.1 | Product name | Havrix Junior |
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.3.8 | INN - Proposed INN | HEPATITIS A VIRUS (INACTIVATED ) ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED PRODUCED ON HUMAN DIPLOID (MRC-5) CELLS |
D.3.9.3 | Other descriptive name | HEPATITIS A VIRUS (INACTIVATED ) ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED PRODUCED ON HUMAN DIPLOID (MRC-5) CELLS |
D.3.9.4 | EV Substance Code | SUB25294 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | ELISA unit enzyme-linked immunosorbent assay unit |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 720 |
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 |