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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447525
First Posted: March 14, 2007
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
March 12, 2007
March 14, 2007
September 11, 2017
February 2007
January 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00447525 on ClinicalTrials.gov Archive Site
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REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children
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

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®
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Poliomyelitis
  • Biological: REVAXIS®
  • Biological: DT-Polio®
  • Experimental: 1
    Intervention: Biological: REVAXIS®
  • Active Comparator: 2
    Intervention: Biological: DT-Polio®
Gajdos V, Soubeyrand B, Vidor E, Richard P, Boyer J, Sadorge C, Fiquet A. Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS (®)) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio (®)) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. Epub 2011 May 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
760
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 6 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00447525
F05-TdI-301
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Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
Sanofi
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP