An open-label, multicentre study to evaluate the immunogenicity and safety of one dose of a diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (REPEVAX®) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (REVAXIS®) in subjects of 40 years of age or older without a previous diphtheria and tetanus-containing booster within the last 20 years

• Conditions: Evaluation of the immunogenicity and safety of one dose of a diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (REPEVAX®) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (REVAXIS®).The MedDRA term corresponding to classification code 10069577 is Pertussis immunisation.; MedDRA version: 13.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 13.1Level: LLTClassification code 10053386Term: Poliomyelitis vaccineSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 13.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 13.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2010-023086-21-DE
• Lead Sponsor: Sanofi Pasteur MSD S.N.C.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-19
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

Subjects have to meet all the following criteria to be eligible for inclusion:
1. Adults aged =40 years at Visit 1
2. No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years before Visit 1
3. Having signed the informed consent form before any specific study procedure
4. Subject able to attend all scheduled visits and to comply with all study procedures
5. 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. Medically diagnosed pertussis disease within the last 10 years prior to Visit 1
2. Receipt of any inactivated vaccine within 14 days prior to Visit 1, or planned vaccination, other than study vaccines, 14 days before or after each study vaccination or study blood sample
3. Receipt of any live vaccine within 28 days prior to Visit 1, or planned vaccination, other than study vaccines, 28 days before or after each study vaccination or study blood sample
4. Febrile illness (body temperature =38.0°C) or moderate or severe acute illness/infection on the day of each vaccination, according to investigator judgment (in that case, vaccination could be postponed)
5. Known pregnancy or positive urine pregnancy test for women of child-bearing age. A woman who is of reproductive potential must agree to remain abstinent or use (or have her partner use) acceptable methods of birth control during the study period
6. History of hypersensitivity or anaphylactic or other allergic reactions to formaldehyde, glutaraldehyde, neomycin, polymyxin B and streptomycin, 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
7. History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
8. History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders after an injection with the same antigens
9. 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 leukaemias, 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 can be included
10. Receipt of immunosuppressive therapy or expected to receive immunosuppressive therapy during the study e.g.:
- Chemotherapy agents to treat cancer received within 6 months prior to Visit 1 or planned treatment with chemotherapy agents during the study
- Daily -or on alternate days- systemic corticosteroids at a dose =20 mg/day of prednisone (or equivalent) for =14 days in the 4 weeks prior or after each vaccination
- Immunomodulator therapy within 6 weeks prior or after each vaccination
11. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks prior to Visit 1 contraindicating intramuscular vaccination
12. Receipt of immunoglobulins or any blood products, other than autologous blood transfusion, given within the 5 months prior to Visit 1 or planned treatment with immunoglobulins or blood products during the study
13. 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
14. Subject deprived of freedom by an administra

Study & Design

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