Safety of REPEVAX® Given One Month After REVAXIS®

Study Overview
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Brief Summary
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Primary objective: To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo. Secondary objectives: To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults. To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.

Official Title
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A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults

Conditions
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Healthy Adult

Intervention / Treatment
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* Biological: REPEVAX® after REVAXIS®
* Biological: REPEVAX® after Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses. Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine. Exclusion Criteria: Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C) Known immunological deficiency Known malignant disease Known neurological disorder Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection Any previous (≤ 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3 Any recent administration (≤ 30 days) of a vaccine or scheduled vaccination

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REPEVAX® after REVAXIS®<br>REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). | Biological: REPEVAX® after REVAXIS®<br>* Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)<br>|
| Active Comparator: REPEVAX® after Placebo<br>Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). | Biological: REPEVAX® after Placebo<br>* Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events |  | 14 days |