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
  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 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®

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
France
Albertville, France, 95880
Albi, France, 81000
Angers, France, 49100
Annecy, France, 74000
Anzin, France, 59410
Arras, France, 62000
Asnieres, France, 92600
Avion, France, 62210
Bassens, France, 33530
Bersee, France, 59235
Besancon, France, 25000
Blois, France, 41000
Boulogne, France, 92100
Brest, France, 29200
Broglie, France, 27270
Caen, France, 14000
Chalon-en-champagne, France, 51000
Champdeniers, France, 79220
Chigny Les Roses, France, 51500
Cholet, France, 49300
Claix, France, 38640
Clamart, France, 92141
Collombey Les Belles, France, 54170
Draguignan, France, 83300
Enghien-les-bains, France, 95880
Floirac, France, 33270
Frouard, France, 54390
Haguenau, France, 67500
Illkirch-graffenstaden, France, 67400
Issy Les Moulineaux, France, 92130
La Neuville Roy, France, 60190
Laon, France, 02000
Le Havre, France, 76600
Les Pieux, France, 50340
Louverne, France, 53950
Louvigne de Bais, France, 35680
Manduel, France, 30129
Marcq-en-barouel, France, 59700
Maromme, France, 76150
Marseille, France, 13004
Miniac Morvan, France, 35540
Montpellier, France, 34080
Montsang/orge, France, 91390
Morangis, France, 91420
Nancy, France, 54000
Nantes, France, 44300
Nogent Sur Marne, France, 94130
Ostwald, France, 67540
Paris, France, 75019
Paris, France, 75013
Plouzane, France, 29280
Poitiers, France, 86000
Pont A Mousson, France, 54700
Quimper, France, 29000
Rouen, France, 76000
Rouen, France, 76100
Saint Sebastien Sur Loir, France, 44230
Saint-ouen, France, 93400
Saint-raphael, France, 83700
Sanary Mer, France, 83110
Sevres, France, 92310
Strasbourg, France, 67000
Toulouse, France, 31000
Villemomble, France, 93250
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov 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:
Diphtheria
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014