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 | 20-valent Pneumococcal Conjugate Vaccine (20vPnC) |
D.3.2 | Product code | PF-06482077 |
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.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 |
D.3.9.4 | EV Substance Code | SUB25373 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 3 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 |
D.3.9.4 | EV Substance Code | SUB25371 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 4 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 |
D.3.9.4 | EV Substance Code | SUB20576 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 5 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 |
D.3.9.4 | EV Substance Code | SUB25370 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 6A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A |
D.3.9.4 | EV Substance Code | SUB126381 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 6B |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B |
D.3.9.4 | EV Substance Code | SUB20577 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F |
D.3.9.4 | EV Substance Code | SUB25369 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 8 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 |
D.3.9.4 | EV Substance Code | SUB25357 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 9V |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V |
D.3.9.4 | EV Substance Code | SUB20578 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 10A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A |
D.3.9.4 | EV Substance Code | SUB25378 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 11A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A |
D.3.9.4 | EV Substance Code | SUB25365 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 12F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F |
D.3.9.4 | EV Substance Code | SUB25364 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 14 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 |
D.3.9.4 | EV Substance Code | SUB20579 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 15B |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B |
D.3.9.4 | EV Substance Code | SUB25363 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 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/ml microgram(s)/millilitre |
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 19A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A |
D.3.9.4 | EV Substance Code | SUB25361 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 19F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F |
D.3.9.4 | EV Substance Code | SUB20581 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 22F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F |
D.3.9.4 | EV Substance Code | SUB25359 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 23F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F |
D.3.9.4 | EV Substance Code | SUB20582 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 33F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F |
D.3.9.4 | EV Substance Code | SUB25326 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.4 |
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 | The vaccine produced to support this trial is identical to Prevenar 13 in the composition of the polysaccharides, CRM, conjugates and AlPO used to prepare the formulated bulk vaccine. The specifications and test methods are the same. |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Pfizer, Inc. |
D.2.1.2 | Country which granted the Marketing Authorisation | United States |
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 | SUB181170 |
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.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 |
D.3.9.4 | EV Substance Code | SUB25373 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 3 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 |
D.3.9.4 | EV Substance Code | SUB25371 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 4 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 |
D.3.9.4 | EV Substance Code | SUB20576 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 5 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 |
D.3.9.4 | EV Substance Code | SUB25370 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 6A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A |
D.3.9.4 | EV Substance Code | SUB126381 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 6B |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B |
D.3.9.4 | EV Substance Code | SUB20577 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F |
D.3.9.4 | EV Substance Code | SUB25369 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 9V |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V |
D.3.9.4 | EV Substance Code | SUB20578 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 14 |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 |
D.3.9.4 | EV Substance Code | SUB20579 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 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/ml microgram(s)/millilitre |
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 19A |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A |
D.3.9.4 | EV Substance Code | SUB25361 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 19F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F |
D.3.9.4 | EV Substance Code | SUB20581 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
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 23F |
D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F |
D.3.9.4 | EV Substance Code | SUB20582 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.4 |
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 |