Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2006-06-30
2007-02-28
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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REPEVAX® after REVAXIS®
REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
REPEVAX® after REVAXIS®
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
REPEVAX® after Placebo
Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
REPEVAX® after Placebo
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
Interventions
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REPEVAX® after REVAXIS®
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
REPEVAX® after Placebo
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Clermont-Ferrand, , France
Lyon, , France
Montpellier, , France
Paris, , France
Countries
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Other Identifiers
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F06-Td5I-301
Identifier Type: -
Identifier Source: org_study_id
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