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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diphtheria, Tetanus, Poliomyelitis, Pertussis

Intervention / Treatment
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* Biological: Diphtheria, tetanus, polio and pertussis vaccination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REPEVAX followed by REVAXIS administration<br> | Biological: Diphtheria, tetanus, polio and pertussis vaccination<br>* 1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diphtheria seroprotection rate |  | 28 to 35 days afeter each vaccine administration | 
| Tetanus seroprotection rate |  | 28 to 35 days after each vaccine administration | 
| Polio seroprotection rate |  | 28 to 35 days after each vaccine administration | 
| Pertussis response rate |  | 28 to 35 days after REPEVAX administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphtheria, Tetanus, Poliomyelitis, Pertussis (acellular), Biological/vaccine