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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014