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REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-Old Children
This study has been completed.
First Received: March 12, 2007   Last Updated: April 3, 2009   History of Changes
Sponsored by: Sanofi Pasteur MSD
Information provided by: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00447525
  Purpose

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
Diphtheria
Tetanus
Poliomyelitis
Biological: REVAXIS®
Biological: DT-Polio®
Phase III

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental Biological: REVAXIS®
2: Active Comparator Biological: DT-Polio®

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447525

  Show 65 Study Locations
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD ( Anne FIQUET MD )
Study ID Numbers: F05-TdI-301
Study First Received: March 12, 2007
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00447525     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Bacterial Infections
Spinal Cord Diseases
Picornaviridae Infections
Central Nervous System Diseases
Diphtheria
Tetanus
Virus Diseases
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Central Nervous System Infections
Poliomyelitis
Myelitis
Enterovirus Infections
Clostridium Infections
Degenerative Motor System Disease
Motor Neuron Disease

Additional relevant MeSH terms:
Bacterial Infections
RNA Virus Infections
Spinal Cord Diseases
Nervous System Diseases
Central Nervous System Diseases
Picornaviridae Infections
Central Nervous System Viral Diseases
Diphtheria
Tetanus
Actinomycetales Infections
Virus Diseases
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Central Nervous System Infections
Poliomyelitis
Corynebacterium Infections
Myelitis
Enterovirus Infections
Clostridium Infections
Motor Neuron Disease

ClinicalTrials.gov processed this record on May 07, 2009