Healthy Adult
Conditions
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: * 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.
Interventions
BIOLOGICALREPEVAX® after REVAXIS®
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
BIOLOGICALREPEVAX® after Placebo
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. | 7 days |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed