Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
NCT ID: NCT01546909
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
PHASE4
278 participants
INTERVENTIONAL
2012-02-29
2012-12-31
Brief Summary
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* To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
* To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3
SECONDARY OBJECTIVES
* To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
* To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
* To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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TETRAVAC-ACELLULAIRE
Diphtheria, tetanus, polio and pertussis vaccination
1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
Interventions
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Diphtheria, tetanus, polio and pertussis vaccination
1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
* Known or suspected immune dysfunction
* Receipt of medications / vaccination that may interfere with study assessments
* Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
* Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* Any medical condition that might interfere with the evaluation of the study objectives
* Febrile illness
11 Years
13 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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SPMSD Investigational Site 120
Angers, , France
SPMSD Investigational Site 103
Arras, , France
SPMSD Investigational Site 155
Asnières, , France
SPMSD Investigational Site 125
Bersée, , France
SPMSD Investigational Site 121
Besançon, , France
SPMSD Investigational Site 141
Besançon, , France
SPMSD Investigational Site 124
Blois, , France
SPMSD Investigational Site 161
Blois, , France
SPMSD Investigational Site 194
Boulogne-Billancourt, , France
SPMSD Investigational Site 148
Brest, , France
SPMSD Investigational Site 117
Caen, , France
SPMSD Investigational Site 147
Caen, , France
SPMSD Investigational Site 163
Champdeniers, , France
SPMSD Investigational Site 135
Châlons-en-Champagne, , France
SPMSD Investigational Site 145
Chigny-les-Roses, , France
SPMSD Investigational Site 157
Cholet, , France
SPMSD Investigational Site 101
Clamart, , France
SPMSD Investigational Site 160
Collombey Les Belles, , France
SPMSD Investigational Site 162
Collombey Les Belles, , France
SPMSD Investigational Site 139
Dax, , France
SPMSD Investigational Site 193
Draguignan, , France
SPMSD Investigational Site 106
Essey-lès-Nancy, , France
SPMSD Investigational Site 123
Essey-lès-Nancy, , France
SPMSD Investigational Site 164
Essey-lès-Nancy, , France
SPMSD Investigational Site 136
Floirac, , France
SPMSD Investigational Site 114
Frouard, , France
SPMSD Investigational Site 150
Haguenau, , France
SPMSD Investigational Site 113
Illkirch-Graffenstaden, , France
SPMSD Investigational Site 197
Le Havre, , France
SPMSD Investigational Site 198
Le Havre, , France
SPMSD Investigational Site 107
Lingolsheim, , France
SPMSD Investigational Site 115
Louverné, , France
SPMSD Investigational Site 140
Manduel, , France
SPMSD Investigational Site 116
Maromme, , France
SPMSD Investigational Site 153
Marseille, , France
SPMSD Investigational Site 134
Montpellier, , France
SPMSD Investigational Site 129
Nogent-sur-Marne, , France
SPMSD Investigational Site 133
Ostwald, , France
SPMSD Investigational Site 128
Poitiers, , France
SPMSD Investigational Site 130
Pont-à-Mousson, , France
SPMSD Investigational Site 151
Quimper, , France
SPMSD Investigational Site 102
Rouen, , France
SPMSD Investigational Site 110
Rouen, , France
SPMSD Investigational Site 199
Rouen, , France
SPMSD Investigational Site 152
Saint-Ouen, , France
Countries
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Other Identifiers
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RVX01C
Identifier Type: -
Identifier Source: org_study_id
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