Safety and Immunogenicity Study 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

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

Primary objective:

• To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
• To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects

Secondary objectives:

• If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
• To describe the immune responses to REPEVAX in these subjects
• To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects

Inclusion Criteria:

• Adults aged ≥40 years
• No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years

Exclusion Criteria:

• Medically diagnosed pertussis disease within the last 10 years
• Receipt of medication / vaccine that may interfere with study assessments
• Febrile illness or moderate or severe acute illness/infection
• Know pregnancy
• History of hypersensitivity or anaphylactic or other allergic reactions 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
• History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
• History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders
• Known or suspected immune dysfunction
• Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
• Chronic disease or intercurrent illness that might interfere with study assessments