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

Sanofi Pasteur, a Sanofi Company1 site in 1 country342 target enrollmentJanuary 2011

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

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

May 2012

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

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

•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

Polio seroprotection rate

Time Frame: 28 to 35 days after each vaccine administration

Diphtheria seroprotection rate

Time Frame: 28 to 35 days afeter each vaccine administration

Pertussis response rate

Time Frame: 28 to 35 days after REPEVAX administration

Tetanus seroprotection rate

Time Frame: 28 to 35 days after each vaccine administration

Solicited injection-site reactions, solicited systemic reactions(From day 0 to day 7 following REPEVAX and REVAXIS vaccination)
Unsolicited injection-site adverse reactions and systemic adverse events(From day 0 to day 28 following REPEVAX and REVAXIS vaccination)
Number and proportion of Serious adverse events(From the first vaccination to the last visit of the subject)