Safety of REPEVAX® Given One Month After REVAXIS®
Study Details
Study Description
Brief Summary
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:
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To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
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To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: REPEVAX® after REVAXIS® REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). |
Biological: REPEVAX® after REVAXIS®
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
|
| Active Comparator: REPEVAX® after Placebo Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). |
Biological: REPEVAX® after Placebo
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
|
Outcome Measures
Primary Outcome Measures
- injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. [7 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
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Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C)
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Known immunological deficiency
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Known malignant disease
-
Known neurological disorder
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Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days
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Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clermont-Ferrand | France | |||
| 2 | Lyon | France | |||
| 3 | Montpellier | France | |||
| 4 | Paris | France |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur, a Sanofi Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- F06-Td5I-301