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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00447525
First received: March 12, 2007
Last updated: September 8, 2017
Last verified: September 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 ( Sanofi Pasteur, a Sanofi Company ):

Enrollment: 760
Actual Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: REVAXIS®
Active Comparator: 2 Biological: DT-Polio®

  Eligibility

Ages Eligible for Study:   6 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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

  Show 64 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00447525     History of Changes
Other Study ID Numbers: F05-TdI-301
Study First Received: March 12, 2007
Last Updated: September 8, 2017

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Prevention of : Diphtheria, Tetanus and Poliomyelitis

Additional relevant MeSH terms:
Tetanus
Tetany
Diphtheria
Poliomyelitis
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 21, 2017