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

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Diphtheria

Pertussis

Tetanus

Treatments

Biological: Diphtheria, tetanus, polio and pertussis vaccination

Study type

Interventional

Funder types

Industry

Identifiers

RPV04C

Details and patient eligibility

About

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

Enrollment

342 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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