E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Repevax: Antibodies response to Diphtheria Toxoid ,Tetanus Toxoid, Pertussis Toxoid*, Filamentous Haemagglutinin, Pertactin, Fimbriae Types 2 and 3, Poliomyelitis Virus Type 1, Poliomyelitis Virus Type 2, Poliomyelitis Virus Type 3.
Vaxigrip: Immunisation against Influenza
*For pertussis immunisation the MedDRA LLT code is 10069577 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062371 |
E.1.2 | Term | Active immunization |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054129 |
E.1.2 | Term | Diphtheria immunisation |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054131 |
E.1.2 | Term | Tetanus immunisation |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053386 |
E.1.2 | Term | Poliomyelitis vaccine |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059429 |
E.1.2 | Term | Influenza immunisation |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069577 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 |
- To demonstrate that REPEVAX administered concomitantly with VAXIGRIP in subjects 60 years of age and older is at least as immunogenic as REPEVAX administered alone and - To demonstrate that VAXIGRIP administered concomitantly with REPEVAX in subjects 60 years of age and older is at least as immunogenic as VAXIGRIP administered alone.
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E.2.2 | Secondary objectives of the trial |
Secondary immunogenicity objectives - To describe the immune responses to REPEVAX and VAXIGRIP when administered concomitantly or not in subjects 60 years of age and older - To describe the immune response to VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older
Secondary safety objective - To describe the safety of REPEVAX and VAXIGRIP when administered concomitantly or not in subjects 60 years of age and older.
Secondary immunogenicity and safety objectives of this study are descriptive, thus no formal hypothesis will be tested.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects have to meet all the following criteria to be eligible for inclusion: 1. Adults aged ≥60 years at Visit 1 2. At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years before Visit 1 3. No influenza vaccine administered during the last 6 months before Visit 1 4. Signed the informed consent form before any specific study procedure 5. Subject able to attend all scheduled visits and to comply with all study procedures 6. Subject affiliated to a health social security system.
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E.4 | Principal exclusion criteria |
Subjects must not be included in the study if they meet at least one of the following criteria: 1. Suspected or documented receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years before Visit 1 2. Suspected or documented receipt of pertussis-containing vaccine within the last 10 years before Visit 1 3. Medically diagnosed pertussis disease within the last 10 years before Visit 1 4. Receipt of any live virus vaccine within 28 days before Visit 1, or planned vaccination with any live virus vaccine during the study 5. Receipt of any other inactivated vaccine within 14 days before Visit 1, or planned vaccination with any other inactivated vaccine during the study 6. Febrile illness (body temperature ≥38.0°C) or moderate or severe acute illness/infection at Visit 1, according to investigator judgment 7. History of hypersensitivity or anaphylactic or other allergic reactions to egg proteins, chick proteins, formaldehyde, glutaraldehyde, polymixin B, neomycin, streptomycin and octoxinol 9, or to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances 8. History of Guillain Barré syndrome or brachial neuritis following a previous vaccination 9. History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or unstable neurological disorders 10. Known or suspected immune dysfunction that is caused by a medical condition, or any other cause - Examples: immune dysfunction including congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, acute or chronic leukaemia, lymphoma, Hodgkin’s disease, multiple myeloma, other conditions affecting the bone marrow or the lymphatic system or generalized malignancy - Exceptions: subjects with prostate or breast cancer with no chemotherapeutic drugs or receiving only hormone blocking drugs, subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and subjects with a history of other malignancies who have been disease-free for at least 6 months before Visit 1 can be included 11. Receipt of immunosuppressive therapy or expected to receive immunosuppressive therapy during the study like: - Chemotherapy agents to treat cancer received within 6 months before Visit 1 - Daily -or on alternate days- systemic corticosteroids at a dose ≥20mg/day of prednisone (or equivalent) for ≥14 days within 4 weeks before Visit 1 - Immunomodulator therapy within 6 weeks before Visit 1 12. Thrombocytopenia, bleeding disorder or anticoagulants within 3 weeks before Visit 1 contraindicating intramuscular vaccination 13. Receipt of immunoglobulins or any blood products, other than autologous blood transfusion, given within 5 months before Visit 1 or planned treatment with immunoglobulins or blood products during the study 14. Chronic disease (e.g., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine 15. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent 16. Participation to another clinical study investigating a vaccine, drug, medical device, or medical procedure within 4 weeks before Visit 1 17. Volunteer having been paid more than 4500€ to take part in biomedical research within 12 months before Visit 1.
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E.5 End points |
E.5.1 | Primary end point(s) |
PRIMARY ENDPOINTS – Immunogenicity REPEVAX • The post-vaccination seroprotection rate (SPR) for diphtheria is defined as the percentage of subjects with antibody titre ≥0.1 IU/mL (seroneutralisation [SN]). • The post-vaccination SPR for tetanus is defined as the percentage of subjects with antibody titre ≥0.1 IU/mL (Enzyme-Linked Immunosorbent Assay [ELISA]). • The post-vaccination percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM). • The post-vaccination SPR for poliomyelitis type 1, 2 and 3 defined as the percentage of subjects with antibody titre ≥8 (1/dil) (SN).
VAXIGRIP • The post-vaccination geometric mean of anti-hemagglutinin (anti-HA) antibody titres (GMT) for each of the three strains, A/H1N1, A/H3N2 and B (Hemagglutination inhibition assay [HI method]).
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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) | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 |
Analysis laboratory blinded of study group |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Separate administration of REPEVAX after Vaxigrip |
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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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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 | Information not present in EudraCT |
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
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The end of the study will be defined as the end of data collection including availability of serology results |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |