REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-Old Children

This study has been completed.
Information provided by:
Sanofi Pasteur MSD Identifier:
First received: March 12, 2007
Last updated: April 3, 2009
Last verified: April 2009

Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

  • Additional immunogenicity assessments.
  • To describe the safety profile of a single dose of REVAXIS® or DT-Polio®

Condition Intervention Phase
Biological: REVAXIS®
Biological: DT-Polio®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age

Resource links provided by NLM:

Further study details as provided by Sanofi Pasteur MSD:

Estimated Enrollment: 734
Study Start Date: February 2007
Study Completion Date: January 2008
Arms Assigned Interventions
Experimental: 1 Biological: REVAXIS®
Active Comparator: 2 Biological: DT-Polio®


Ages Eligible for Study:   6 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy child without chronic severe disease of either gender,
  2. 6 year-old child on vaccination day,
  3. Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16 - 18 months of life (±2 months),
  4. Consent form signed by both parents, or by the legal representative, properly informed about the study.

Exclusion Criteria:

  1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
  2. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
  3. Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
  4. Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
  5. Child who had received within the previous 150 days or who will receive during the course of the study, any immunoglobulins or blood derived products,
  6. Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
  7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
  8. Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
  9. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
  10. Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination
  Contacts and Locations
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Please refer to this study by its identifier: NCT00447525

  Show 64 Study Locations
Sponsors and Collaborators
Sanofi Pasteur MSD
Study Director: Anne FIQUET, MD SPMSD
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD Identifier: NCT00447525     History of Changes
Other Study ID Numbers: F05-TdI-301 
Study First Received: March 12, 2007
Last Updated: April 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi Pasteur MSD:
Prevention of : Diphtheria, Tetanus and Poliomyelitis

Additional relevant MeSH terms:
Actinomycetales Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Clostridium Infections
Corynebacterium Infections
Enterovirus Infections
Gram-Positive Bacterial Infections
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases processed this record on May 26, 2016