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
- Conditions
- DiphtheriaTetanusPoliomyelitisPertussis
- Interventions
- Biological: Diphtheria, tetanus, polio and pertussis vaccination
- Registration Number
- NCT01287949
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 342
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description REPEVAX followed by REVAXIS administration Diphtheria, tetanus, polio and pertussis vaccination -
- Primary Outcome Measures
Name Time Method Diphtheria seroprotection rate 28 to 35 days afeter each vaccine administration Polio seroprotection rate 28 to 35 days after each vaccine administration Pertussis response rate 28 to 35 days after REPEVAX administration Tetanus seroprotection rate 28 to 35 days after each vaccine administration
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sanofi Pasteur MSD investigational site
🇩🇪Rodgau, Germany