An open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis adsorbed vaccine (REPEVAX) administered concomitantly versus non-concomitantly with an influenza vaccine (VAXIGRIP) to subjects of 60 years of age and older

• Conditions: 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; MedDRA version: 14.0Level: PTClassification code 10059429Term: Influenza immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: LLTClassification code 10062371Term: Active immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: LLTClassification code 10053386Term: Poliomyelitis vaccineSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2010-021068-13-DE
• Lead Sponsor: Sanofi Pasteur MSD S.N.C.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 954

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. For France only: Subject affiliated to a health social security system
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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. For

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified