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Summary
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| EudraCT Number: | 2012-002727-15 |
| Sponsor's Protocol Code Number: | 114174 |
| Clinical Trial Type: | Outside EU/EEA |
| Date on which this record was first entered in the EudraCT database: | 2015-06-22 |
| Trial results | View results |
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A. Protocol Information
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| A.2 | EudraCT number | 2012-002727-15 | |
| 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 | 114174 | |
| A.5.2 | US NCT (ClinicalTrials.gov registry) number | NCT01262872 | |
| A.7 | Trial is part of a Paediatric Investigation Plan | No | |
| A.8 | EMA Decision number of Paediatric Investigation Plan | ||
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B. Sponsor Information
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|---|---|---|
| B.Sponsor: 1 | ||
| B.1.1 | Name of Sponsor | GlaxoSmithKline Biologicals |
| B.1.3.4 | Country | Belgium |
| 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 | GlaxoSmithKline Biologicals |
| B.4.2 | Country | Belgium |
| B.5 Contact point designated by the sponsor for further information on the trial | ||
| B.5.1 | Name of organisation | GlaxoSmithKline Biologicals |
| B.5.2 | Functional name of contact point | Clinical Disclosure Advisor |
| B.5.3 | Address: | |
| B.5.3.1 | Street Address | Rue de l'Institut, 89 |
| B.5.3.2 | Town/ city | Rixensart |
| B.5.3.3 | Post code | 1330 |
| B.5.3.4 | Country | Belgium |
| B.5.4 | Telephone number | 442089904466 |
| B.5.6 | GSKClinicalSupportHD@gsk.com | |
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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 | 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.3.2 | Product code | 10Pn-PD-DiT-dPly-PhtD 10 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38400 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38432 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38448 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38449 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38459 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38342 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38402 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18CCONJUGATED TO TETANUS TOXOID CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38409 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO DIPHTHERIA TOXOID CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38414 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38420 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.2 | Current sponsor code | dPly |
| D.3.9.3 | Other descriptive name | Pneumolysin toxoid |
| 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 | - |
| D.3.9.2 | Current sponsor code | PhtD |
| D.3.9.3 | Other descriptive name | Pneumoccocal histidine-triad type D protein |
| D.3.9.4 | EV Substance Code | SUB31550 |
| 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.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 | 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 | 10Pn-PD-DiT-dPly-PhtD 30 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38400 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38432 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38448 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38449 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38459 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38342 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38402 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18CCONJUGATED TO TETANUS TOXOID CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38409 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO DIPHTHERIA TOXOID CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38414 |
| 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 | - |
| D.3.9.2 | Current sponsor code | dPly |
| D.3.9.3 | Other descriptive name | Pneumolysin toxoid |
| 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 | 30 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.2 | Current sponsor code | PhtD |
| D.3.9.3 | Other descriptive name | Pneumoccoal histidine-triad type D protein |
| D.3.9.4 | EV Substance Code | SUB31550 |
| 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 | 30 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38420 |
| 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 | 1 |
| 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: 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 | Synflorix |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline Biologicals |
| 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.3.2 | Product code | 10PN-PD-DiT |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38400 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38432 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38448 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38449 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38459 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38342 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38402 |
| 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 | 1 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18CCONJUGATED TO TETANUS TOXOID CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38409 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO DIPHTHERIA TOXOID CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38414 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN |
| D.3.9.4 | EV Substance Code | SUB38420 |
| 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 | 1 |
| 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: 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 | Prevenar 13 |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Pfizer Limited |
| 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.3.4 | 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 | - |
| 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 | - |
| 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 | - |
| 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 | - |
| 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 | - |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 |
| D.3.9.4 | EV Substance Code | SUB25356 |
| 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 | - |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 |
| D.3.9.4 | EV Substance Code | SUB25343 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 |
| D.3.9.4 | EV Substance Code | SUB25341 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 |
| D.3.9.4 | EV Substance Code | SUB25338 |
| 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 | - |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 |
| D.3.9.4 | EV Substance Code | SUB25337 |
| 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 | - |
| D.3.9.3 | Other descriptive name | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 |
| D.3.9.4 | EV Substance Code | SUB25368 |
| 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: 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 | Tritanrix HepB |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline Biologicals |
| 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.3.2 | Product code | DTPw-HBV |
| 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 | - |
| D.3.9.2 | Current sponsor code | D |
| 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 | - |
| D.3.9.2 | Current sponsor code | T |
| 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 | 60 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.2 | Current sponsor code | Pw |
| D.3.9.3 | Other descriptive name | WHOLE-CELL BORDETELLA PERTUSSIS (INACTIVATED) |
| D.3.9.4 | EV Substance Code | SUB38355 |
| 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 | 4 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.2 | Current sponsor code | HBsAg |
| D.3.9.3 | Other descriptive name | r-DNA 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.3.11 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: 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 | Polio Sabin (Oral) |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline Biologicals |
| 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.3.2 | Product code | OPV |
| D.3.4 | Pharmaceutical form | Oral suspension |
| 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 | - |
| D.3.9.3 | Other descriptive name | POLIOVIRUS TYPE 1, STRAIN LSC, 2AB |
| D.3.9.4 | EV Substance Code | SUB38124 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | log10 CCID50 log10 cell culture infective dose 50 |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 6.0 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | POLIOVIRUS TYPE 2, STRAIN P 712, CH, 2AB |
| D.3.9.4 | EV Substance Code | SUB38128 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | log10 CCID50 log10 cell culture infective dose 50 |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 5.0 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | - |
| D.3.9.3 | Other descriptive name | POLIOVIRUS TYPE 3, STRAIN LEON 12A, 1B |
| D.3.9.4 | EV Substance Code | SUB38130 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | log10 CCID50 log10 cell culture infective dose 50 |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 5.5 |
| 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 | 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: 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 | M-Vac |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Serum Institute of India LTD |
| D.2.1.2 | Country which granted the Marketing Authorisation | India |
| 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.3.4 | Pharmaceutical form | Powder and suspension 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 | - |
| D.3.9.3 | Other descriptive name | FREEZE-DRIED ATTENUATED MEASLES VIRUS |
| D.3.9.4 | EV Substance Code | SUB75506 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | CCID50 cell culture infective dose 50 |
| D.3.10.2 | Concentration type | not less then |
| D.3.10.3 | Concentration number | 1000 |
| 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: 8 | ||
| 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 | Stamaril |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Sanofi Pasteur MSD Limited |
| 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.3.4 | 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 | - |
| D.3.9.3 | Other descriptive name | YELLOW FEVER VIRUS STRAIN 17D-204 (LIVE, ATTENUATED) |
| D.3.9.4 | EV Substance Code | SUB26732 |
| 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 | 1000 |
| 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: 9 | ||
| 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 | Hiberix |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline Biologicals |
| 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.3.2 | Product code | Hib |
| 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 | - |
| D.3.9.2 | Current sponsor code | Hib |
| 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 | 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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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] - Bacterial Infections and Mycoses [C01] | |||||||||||||||
| MedDRA Classification | |||||||||||||||||
| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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| 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 |
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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 | Yes | |||||||||||||||
| E.6.3 | Therapy | No | |||||||||||||||
| E.6.4 | Safety | No | |||||||||||||||
| E.6.5 | Efficacy | No | |||||||||||||||
| 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 |
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| 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) | No | |||||||||||||||
| 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 | Yes | |||||||||||||||
| E.8.1.7.1 | Other trial design description |
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| 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 | 8 | |||||||||||||||
| E.8.3 | Will this trial be conducted at a single site globally? | Yes | |||||||||||||||
| E.8.4 | Will this trial be conducted at multiple sites globally? | No | |||||||||||||||
| E.8.6 Trial involving sites outside the EEA | |||||||||||||||||
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes | |||||||||||||||
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | Yes | |||||||||||||||
| 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 |
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| E.8.9 Initial estimate of the duration of the trial | |||||||||||||||||
| E.8.9.2 | In all countries concerned by the trial years | 0 | |||||||||||||||
| E.8.9.2 | In all countries concerned by the trial months | 10 | |||||||||||||||
| E.8.9.2 | In all countries concerned by the trial days | 0 | |||||||||||||||
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F. Population of Trial Subjects
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|---|---|---|---|
| F.1 Age Range | |||
| F.1.1 | Trial has subjects under 18 | Yes | |
| F.1.1 | Number of subjects for this age range: | 1320 | |
| 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) | Yes | |
| F.1.1.4.1 | Number of subjects for this age range: | 1200 | |
| F.1.1.5 | Children (2-11years) | Yes | |
| F.1.1.5.1 | Number of subjects for this age range: | 120 | |
| 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 | No | |
| 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 | No | |
| F.4 Planned number of subjects to be included | |||
| F.4.2 | For a multinational trial | ||
| F.4.2.2 | In the whole clinical trial | 1320 | |
| 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) |
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G. Investigator Networks to be involved in the Trial
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H.4 Third Country in which the Trial was first authorised
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|---|---|---|
| H.4.1 | Third Country in which the trial was first authorised: | Gambia |
