REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children
NCT ID: NCT00447525
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
760 participants
INTERVENTIONAL
2007-02-28
2008-01-31
Brief Summary
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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®
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
REVAXIS®
2
DT-Polio®
Interventions
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REVAXIS®
DT-Polio®
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
6 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Albertville, , France
Albi, , France
Angers, , France
Annecy, , France
Anzin, , France
Arras, , France
Asnières, , France
Avion, , France
Bassens, , France
Bersée, , France
Besançon, , France
Blois, , France
Boulogne, , France
Brest, , France
Broglie, , France
Caen, , France
Chalon-en-champagne, , France
Champdeniers, , France
Chigny-les-Roses, , France
Cholet, , France
Claix, , France
Clamart, , France
Collombey Les Belles, , France
Draguignan, , France
Enghien-les-Bains, , France
Floirac, , France
Frouard, , France
Haguenau, , France
Illkirch-Graffenstaden, , France
Issy-les-Moulineaux, , France
La Neuville-Roy, , France
Laon, , France
Le Havre, , France
Les Pieux, , France
Louverné, , France
Louvigné-de-Bais, , France
Manduel, , France
Marcq-en-barouel, , France
Maromme, , France
Marseille, , France
Miniac-Morvan, , France
Montpellier, , France
Montsang/orge, , France
Morangis, , France
Nancy, , France
Nantes, , France
Nogent-sur-Marne, , France
Ostwald, , France
Paris, , France
Paris, , France
Plouzané, , France
Poitiers, , France
Pont-à-Mousson, , France
Quimper, , France
Rouen, , France
Rouen, , France
Saint Sebastien Sur Loir, , France
Saint-Ouen, , France
Saint-Raphaël, , France
Sanary Mer, , France
Sèvres, , France
Strasbourg, , France
Toulouse, , France
Villemomble, , France
Countries
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References
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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.
Other Identifiers
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F05-TdI-301
Identifier Type: -
Identifier Source: org_study_id
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