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Safety of REPEVAX® Given One Month After REVAXIS®

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ClinicalTrials.gov Identifier: NCT00400309
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( 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.

Condition or disease Intervention/treatment Phase
Healthy Adult Biological: REPEVAX® after REVAXIS® Biological: REPEVAX® after Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : June 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Arm Intervention/treatment
Experimental: REPEVAX® after REVAXIS®
REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
Biological: REPEVAX® after REVAXIS®
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
Active Comparator: REPEVAX® after Placebo
Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
Biological: REPEVAX® after Placebo
Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400309


Locations
France
Clermont-Ferrand, France
Lyon, France
Montpellier, France
Paris, France
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00400309     History of Changes
Other Study ID Numbers: F06-Td5I-301
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017