Summary
|
|
---|---|
EudraCT Number: | 2018-003451-38 |
Sponsor's Protocol Code Number: | OVG2018/05 |
National Competent Authority: | UK - MHRA |
Clinical Trial Type: | EEA CTA |
Trial Status: | GB - no longer in EU/EEA |
Date on which this record was first entered in the EudraCT database: | 2019-01-31 |
Trial results | View results |
Expand All
Collapse All
A. Protocol Information
|
|||
---|---|---|---|
A.1 | Member State Concerned | UK - MHRA | |
A.2 | EudraCT number | 2018-003451-38 | |
A.3 | Full title of the trial |
|
|
A.3.1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language |
|
|
A.3.2 | Name or abbreviated title of the trial where available |
|
|
A.4.1 | Sponsor's protocol code number | OVG2018/05 | |
A.7 | Trial is part of a Paediatric Investigation Plan | No | |
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
|
||
---|---|---|
B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | Clinical Trials and Research Governance (CTRG) |
B.1.3.4 | Country | United Kingdom |
B.3.1 and B.3.2 | Status of the sponsor | Non-Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | |
B.4.2 | Country | |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | Oxford Vaccine Group |
B.5.2 | Functional name of contact point | Professor Matthew Snape |
B.5.3 | Address: | |
B.5.3.1 | Street Address | CCVTM, Churchill Hospital, Old Rd |
B.5.3.2 | Town/ city | Oxford |
B.5.3.3 | Post code | OX3 7LE |
B.5.3.4 | Country | United Kingdom |
B.5.4 | Telephone number | 01865611400 |
B.5.6 | matthew.snape@paediatrics.ox.ac.uk |
D. IMP Identification
|
||
---|---|---|
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 | INFANRIX-HEXA |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline UK |
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 | INFANRIX-HEXA |
D.3.4 | Pharmaceutical form | Suspension for injection |
D.3.4.1 | Specific paediatric formulation | Yes |
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 | Diphtheria toxoid |
D.3.9.4 | EV Substance Code | AS1 |
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 | Tetanus toxoid |
D.3.9.4 | EV Substance Code | AS2 |
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 | 40 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Bordetella pertussis antigens |
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 | range |
D.3.10.3 | Concentration number | 8 to 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Poliovirus (inactivated) IPV |
D.3.9.4 | EV Substance Code | AS4 |
D.3.10 | Strength | |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 8 to 40 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Haemophilius influenzae type b polysaccharide |
D.3.9.3 | Other descriptive name | polyribosylribitol phosphate/PRP |
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 | range |
D.3.10.3 | Concentration number | 10 to 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Hepatitis B surface antigen |
D.3.9.3 | Other descriptive name | HBs |
D.3.9.4 | EV Substance Code | AS13 |
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 | 10 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | 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 | 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 | Vaxelis (DTaP -HB-IPV-Hib) |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MCM Vaccine B.V., |
D.2.1.2 | Country which granted the Marketing Authorisation | Netherlands |
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 | Vaxelis (DTaP -HB-IPV-Hib) |
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 | Diphtheria Toxoid |
D.3.9.4 | EV Substance Code | AS7 |
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 | 20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Tetanus Toxoid |
D.3.9.4 | EV Substance Code | AS8 |
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 | 40 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Bordetella pertussis antigens |
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 | 3 to 20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Hepatitis B surface antigen |
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 | 10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Poliovirus (Inactivated) |
D.3.9.4 | EV Substance Code | AS11 |
D.3.10 | Strength | |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8 to 40 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Haemophilus influenzae type b polysaccharide conjugated to meningococcal protein |
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 | 3 to 50 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | 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 | Bexsero |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GSK Vaccines S.r.l. |
D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.1 | Product name | Bexsero |
D.3.4 | 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 | Recombinant Neisseria meningitidis group B NHBA fusion protein |
D.3.9.4 | EV Substance Code | AS14 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 50 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Recombinant Neisseria meningitidis group B NadA protein |
D.3.9.4 | EV Substance Code | AS15 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 50 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Recombinant Neisseria meningitidis group B fHbp fusion protein |
D.3.9.4 | EV Substance Code | AS16 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 50 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Outer membrane vesicles (OMV) from Neisseria meningitidis group B |
D.3.9.4 | EV Substance Code | AS17 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 25 |
D.3.11 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) | No |
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 | 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 | 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 | 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 1 |
D.3.9.4 | EV Substance Code | AS18 |
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 | AS19 |
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 | AS20 |
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 | AS21 |
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 | AS22 |
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 | AS23 |
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 | AS24 |
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 | AS25 |
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 | AS26 |
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 | AS27 |
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 | AS28 |
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 | AS29 |
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 | AS30 |
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 | CRM197 carrier protein |
D.3.9.4 | EV Substance Code | AS31 |
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 | 32 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Aluminium |
D.3.9.4 | EV Substance Code | AS32 |
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) | No |
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 | Menitorix |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline Biologicals s.a. |
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 | Menitorix |
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 | Haemophilus type b polysachharide |
D.3.9.4 | EV Substance Code | AS33 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Tetanus toxoid |
D.3.9.4 | EV Substance Code | AS34 |
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 | 17.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Neisseria meningitidis serogroup C polysaccharide |
D.3.9.4 | EV Substance Code | AS35 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | No |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
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: 6 | ||
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 | Rotarix |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline Biologicals s.a. |
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 | Rotarix |
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 | Human rotavirus RIX4414 strain (live attenuated) |
D.3.9.4 | EV Substance Code | AS37 |
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 | 10 6.0 |
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) | No |
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 | 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 | M-M-RVAXPRO |
D.2.1.1.2 | Name of the Marketing Authorisation holder | MSD VACCINS |
D.2.1.2 | Country which granted the Marketing Authorisation | France |
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 | M-M-RVAXPRO |
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 | Measles virus |
D.3.9.4 | EV Substance Code | AS38 |
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 | 1 x 103 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Mumps virus |
D.3.9.4 | EV Substance Code | AS39 |
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 | 12.5 x 103 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Rubella virus |
D.3.9.4 | EV Substance Code | AS40 |
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 | 1 x 103 |
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) | No |
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 | 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 | Priorix |
D.2.1.1.2 | Name of the Marketing Authorisation holder | GlaxoSmithKline UK |
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 | Priorix |
D.3.4 | Pharmaceutical form | |
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 | Live attenuated measles virus |
D.3.9.4 | EV Substance Code | AS41 |
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 | 10 3.0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Live attenuated mumps virus |
D.3.9.4 | EV Substance Code | AS42 |
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 | 10 3.7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | Live attenuated rubella virus |
D.3.9.4 | EV Substance Code | AS43 |
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 | 10 3.0 |
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) | No |
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
|
||
---|---|---|
D.8 Placebo: 1 | ||
D.8.1 | Is a Placebo used in this Trial? | Yes |
E. General Information on the Trial
|
|||
---|---|---|---|
E.1 Medical condition or disease under investigation | |||
E.1.1 | Medical condition(s) being investigated |
|
|
E.1.1.1 | Medical condition in easily understood language |
|
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] | |
MedDRA Classification | |||
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 |
|
|
E.2.2 | Secondary objectives of the trial |
|
|
E.2.3 | Trial contains a sub-study | No | |
E.3 | Principal inclusion criteria |
|
|
E.4 | Principal exclusion criteria |
|
|
E.5 End points | |||
E.5.1 | Primary end point(s) |
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
|
E.5.2 | Secondary end point(s) |
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
|
E.6 and E.7 Scope of the trial | |||
E.6 | Scope of the trial | ||
E.6.1 | Diagnosis | No | |
E.6.2 | Prophylaxis | No | |
E.6.3 | Therapy | 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 |
|
|
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) | No | |
E.7.3 | Therapeutic confirmatory (Phase III) | No | |
E.7.4 | Therapeutic use (Phase IV) | Yes | |
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 | No | |
E.8.1.5 | Parallel group | No | |
E.8.1.6 | Cross over | No | |
E.8.1.7 | Other | No | |
E.8.2 | Comparator of controlled trial | ||
E.8.2.1 | Other medicinal product(s) | Yes | |
E.8.2.2 | Placebo | No | |
E.8.2.3 | Other | No | |
E.8.2.4 | Number of treatment arms in the trial | 2 | |
E.8.3 | The trial involves single site in the Member State concerned | No | |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes | |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 | |
E.8.5 | The trial involves multiple Member States | No | |
E.8.6 Trial involving sites outside the EEA | |||
E.8.6.1 | Trial being conducted both within and outside the EEA | No | |
E.8.6.2 | Trial being conducted completely outside of the EEA | No | |
E.8.7 | Trial has a data monitoring committee | No | |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial |
|
|
E.8.9 Initial estimate of the duration of the trial | |||
E.8.9.1 | In the Member State concerned years | 2 | |
E.8.9.1 | In the Member State concerned months | 6 | |
E.8.9.1 | In the Member State concerned days | 0 | |
E.8.9.2 | In all countries concerned by the trial years | 2 | |
E.8.9.2 | In all countries concerned by the trial months | 6 | |
E.8.9.2 | In all countries concerned by the trial days | 0 |
F. Population of Trial Subjects
|
|||
---|---|---|---|
F.1 Age Range | |||
F.1.1 | Trial has subjects under 18 | Yes | |
F.1.1 | Number of subjects for this age range: | 240 | |
F.1.1.1 | In Utero | No | |
F.1.1.1.1 | Number of subjects for this age range: | 0 | |
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No | |
F.1.1.2.1 | Number of subjects for this age range: | 0 | |
F.1.1.3 | Newborns (0-27 days) | No | |
F.1.1.3.1 | Number of subjects for this age range: | 0 | |
F.1.1.4 | Infants and toddlers (28 days-23 months) | Yes | |
F.1.1.4.1 | Number of subjects for this age range: | 240 | |
F.1.1.5 | Children (2-11years) | No | |
F.1.1.5.1 | Number of subjects for this age range: | 0 | |
F.1.1.6 | Adolescents (12-17 years) | No | |
F.1.1.6.1 | Number of subjects for this age range: | 0 | |
F.1.2 | Adults (18-64 years) | No | |
F.1.2.1 | Number of subjects for this age range: | 0 | |
F.1.3 | Elderly (>=65 years) | No | |
F.1.3.1 | Number of subjects for this age range: | 0 | |
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.4.1 | In the member state | 240 | |
F.4.2 | For a multinational trial | ||
F.4.2.2 | In the whole clinical trial | 240 | |
F.5 | Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition) |
|
G. Investigator Networks to be involved in the Trial
|
||
---|---|---|
G.4 Investigator Network to be involved in the Trial: 1 |
N. Review by the Competent Authority or Ethics Committee in the country concerned
|
||
---|---|---|
N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2019-02-19 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
|
N. | Date of Ethics Committee Opinion | 2019-02-21 |
P. End of Trial
|
||
---|---|---|
P. | End of Trial Status | GB - no longer in EU/EEA |