D.IMP: 1 |
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Prevenar 13 |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ |
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.3.2 | Product code | EU/1/09/590/001 |
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 1 |
D.3.9.4 | EV Substance Code | AS1 |
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 |
D.3.9.4 | EV Substance Code | AS2 |
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 |
D.3.9.4 | EV Substance Code | AS3 |
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 5 |
D.3.9.4 | EV Substance Code | AS4 |
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 |
D.3.9.4 | EV Substance Code | AS5 |
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 |
D.3.9.4 | EV Substance Code | AS6 |
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 |
D.3.9.4 | EV Substance Code | AS7 |
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 |
D.3.9.4 | EV Substance Code | AS8 |
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 |
D.3.9.4 | EV Substance Code | AS9 |
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.3.9.4 | EV Substance Code | AS10 |
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 |
D.3.9.4 | EV Substance Code | AS11 |
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 |
D.3.9.4 | EV Substance Code | AS12 |
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 |
D.3.9.4 | EV Substance Code | AS13 |
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 | Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate |
D.3.9.4 | EV Substance Code | AS14 |
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 | 0.125 |
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 | AVAXIM |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Sanofi Pasteur MSD Limited, Mallards Reach, Maidenhead, Berkshire, SL6 1QP |
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 | AVAXIM |
D.3.4 | Pharmaceutical form | Suspension 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 | Hepatitis A virus, GBM strain (inactivated) |
D.3.9.4 | EV Substance Code | AS15 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | U unit(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 160 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al) |
D.3.9.4 | EV Substance Code | AS16 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg/g milligram(s)/gram |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.3 |
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 | 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 |