Safety of REPEVAX® Given One Month After REVAXIS®

Phase 3

Completed

• Conditions: Healthy Adult
• Interventions: Biological: REPEVAX® after Placebo; Biological: REPEVAX® after REVAXIS®

• Registration Number: NCT00400309
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-16
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REPEVAX® after Placebo	REPEVAX® after Placebo	Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
REPEVAX® after REVAXIS®	REPEVAX® after REVAXIS®	REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).

Primary Outcome Measures

Name	Time	Method
injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.	7 days

Secondary Outcome Measures

Name	Time	Method
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