Safety of REPEVAX® Given One Month After REVAXIS®

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00400309
First received: November 15, 2006
Last updated: April 3, 2009
Last verified: April 2009
  Purpose

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.

Condition Intervention Phase
Healthy Adult
Biological: Tetanus, Diphtheria, Poliomyelitis and Pertussis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. [ Time Frame: 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 [ Time Frame: 14 days ]

Enrollment: 500
Study Start Date: June 2006
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400309

Locations
France
Clermont-Ferrand, France
Lyon, France
Montpellier, France
Paris, France
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided

Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00400309     History of Changes
Other Study ID Numbers: F06-Td5I-301
Study First Received: November 15, 2006
Last Updated: April 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 17, 2014