Safety of REPEVAX® Given One Month After REVAXIS®

Sanofi

Status and phase: Completed; Phase 3

Conditions: Healthy Adult

Treatments: Biological: REPEVAX® after Placebo; Biological: REPEVAX® after REVAXIS®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400309

F06-Td5I-301

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

REPEVAX® after REVAXIS®

Experimental group

Description:

REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).

Treatment:

Biological: REPEVAX® after REVAXIS®

REPEVAX® after Placebo

Active Comparator group

Description:

Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).

Treatment:

Biological: REPEVAX® after Placebo