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OpenTrials
Completed

NCT Number: NCT00400309

Safety of REPEVAX® Given One Month After REVAXIS®

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REPEVAX® after REVAXIS®

Biological

Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)

REPEVAX® after Placebo

Biological

Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo

Primary outcomes

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

    Time frame: 7 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 16, 2006
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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