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

Sanofi Pasteur, a Sanofi Company342 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

342

Conditions

Diphtheria Tetanus Poliomyelitis

Eligibility

Sex: ALLMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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