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:

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

U.S. FDA Resources

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 ]

Eligibility

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

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 May 22, 2013