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

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00447525
First received: March 12, 2007
Last updated: April 3, 2009
Last verified: April 2009

March 12, 2007
April 3, 2009
February 2007
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
734
January 2008
Not Provided

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
Both
6 Years to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00447525
F05-TdI-301
Not Provided
Anne FIQUET MD, Sanofi Pasteur MSD
Sanofi Pasteur MSD
Not Provided
Study Director: Anne FIQUET, MD SPMSD
Sanofi Pasteur MSD
April 2009

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