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
1 other identifier
interventional
760
1 country
64
Brief Summary
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®
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
Shorter than P25 for phase_3
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 12, 2007
CompletedFirst Posted
Study publicly available on registry
March 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedSeptember 11, 2017
September 1, 2017
11 months
March 12, 2007
September 8, 2017
Conditions
Keywords
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy child without chronic severe disease of either gender,
- year-old child on vaccination day,
- 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),
- Consent form signed by both parents, or by the legal representative, properly informed about the study.
You may not qualify if:
- Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
- Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
- Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
- Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
- 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,
- Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
- Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
- Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
- Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
- Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Unknown Facility
Albertville, 95880, France
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Albi, 81000, France
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Angers, 49100, France
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Annecy, 74000, France
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Anzin, 59410, France
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Arras, 62000, France
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Asnières, 92600, France
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Avion, 62210, France
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Bassens, 33530, France
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Bersée, 59235, France
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Besançon, 25000, France
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Blois, 41000, France
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Boulogne, 92100, France
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Brest, 29200, France
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Broglie, 27270, France
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Caen, 14000, France
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Chalon-en-champagne, 51000, France
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Champdeniers, 79220, France
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Chigny-les-Roses, 51500, France
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Cholet, 49300, France
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Claix, 38640, France
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Clamart, 92141, France
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Collombey Les Belles, 54170, France
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Draguignan, 83300, France
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Enghien-les-Bains, 95880, France
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Floirac, 33270, France
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Frouard, 54390, France
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Haguenau, 67500, France
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Illkirch-Graffenstaden, 67400, France
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Issy-les-Moulineaux, 92130, France
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La Neuville-Roy, 60190, France
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Laon, 02000, France
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Le Havre, 76600, France
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Les Pieux, 50340, France
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Louverné, 53950, France
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Louvigné-de-Bais, 35680, France
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Manduel, 30129, France
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Marcq-en-barouel, 59700, France
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Maromme, 76150, France
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Marseille, 13004, France
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Miniac-Morvan, 35540, France
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Montpellier, 34080, France
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Montsang/orge, 91390, France
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Morangis, 91420, France
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Nancy, 54000, France
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Nantes, 44300, France
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Nogent-sur-Marne, 94130, France
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Ostwald, 67540, France
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Paris, 75013, France
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Paris, 75019, France
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Plouzané, 29280, France
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Poitiers, 86000, France
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Pont-à-Mousson, 54700, France
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Quimper, 29000, France
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Rouen, 76000, France
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Rouen, 76100, France
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Saint Sebastien Sur Loir, 44230, France
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Saint-Ouen, 93400, France
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Saint-Raphaël, 83700, France
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Sanary Mer, 83110, France
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Sèvres, 92310, France
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Strasbourg, 67000, France
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Toulouse, 31000, France
Unknown Facility
Villemomble, 93250, France
Related Publications (1)
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 ((R))) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio ((R))) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. doi: 10.4161/hv.7.5.14982. Epub 2011 May 1.
PMID: 21441781DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2007
First Posted
March 14, 2007
Study Start
February 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
September 11, 2017
Record last verified: 2017-09