Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
- Conditions
- DiphtheriaTetanusPoliomyelitis
- Interventions
- Biological: Diphtheria, tetanus, polio and pertussis vaccination
- Registration Number
- NCT01546909
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
PRIMARY OBJECTIVES
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
- Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301
- Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TETRAVAC-ACELLULAIRE Diphtheria, tetanus, polio and pertussis vaccination -
- Primary Outcome Measures
Name Time Method Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL Pre-booster dose (Day 0) Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL Pre-booster dose (Day 0) Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution) Pre-booster dose (Day 0) Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution) Pre-booster dose (Day 0) Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution) Pre-booster dose (Day 0) Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL 1 month post-booster dose Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL 1 month post-booster dose Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution) 1 month post-booster dose Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution) 1 month post-booster dose Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution) 1 month post-booster dose
- Secondary Outcome Measures
Name Time Method Geometric mean titer for diphtheria Pre-booster (Day 0) and 1 month post-booster dose Geometric mean titer for tetanus Pre-booster (Day 0) and 1 month post-booster dose Geometric mean titer for polio type 1 Pre-booster (Day 0) and 1 month post-booster dose Geometric mean titer for polio type 2 Pre-booster (Day 0) and 1 month post-booster dose Geometric mean titer for polio type 3 Pre-booster (Day 0) and 1 month post-booster dose Solicited injection site and solicited systemic reactions From Day 0 to Day 7 post vaccination Unsolicited injection site reactions and unsolicited systemic adverse events From Day 0 to Day 28 days post vaccination Serious adverse events From signature of informed consent up to last study visit of the subject
Trial Locations
- Locations (45)
SPMSD Investigational Site 120
🇫🇷Angers, France
SPMSD Investigational Site 103
🇫🇷Arras, France
SPMSD Investigational Site 141
🇫🇷Besancon, France
SPMSD Investigational Site 117
🇫🇷Caen, France
SPMSD Investigational Site 124
🇫🇷Blois, France
SPMSD Investigational Site 106
🇫🇷Essey Les Nancy, France
SPMSD Investigational Site 155
🇫🇷Asnieres, France
SPMSD Investigational Site 139
🇫🇷DAX, France
SPMSD Investigational Site 125
🇫🇷Bersee, France
SPMSD Investigational Site 135
🇫🇷Chalons En Champagne, France
SPMSD Investigational Site 145
🇫🇷Chigny Les Roses, France
SPMSD Investigational Site 157
🇫🇷Cholet, France
SPMSD Investigational Site 163
🇫🇷Champdeniers, France
SPMSD Investigational Site 161
🇫🇷Blois, France
SPMSD Investigational Site 101
🇫🇷Clamart, France
SPMSD Investigational Site 194
🇫🇷Boulogne Billancourt, France
SPMSD Investigational Site 121
🇫🇷Besancon, France
SPMSD Investigational Site 116
🇫🇷Maromme, France
SPMSD Investigational Site 128
🇫🇷Poitiers, France
SPMSD Investigational Site 129
🇫🇷Nogent Sur Marne, France
SPMSD Investigational Site 110
🇫🇷Rouen, France
SPMSD Investigational Site 130
🇫🇷Pont A Mousson, France
SPMSD Investigational Site 148
🇫🇷Brest, France
SPMSD Investigational Site 147
🇫🇷Caen, France
SPMSD Investigational Site 102
🇫🇷Rouen, France
SPMSD Investigational Site 140
🇫🇷Manduel, France
SPMSD Investigational Site 136
🇫🇷Floirac, France
SPMSD Investigational Site 150
🇫🇷Haguenau, France
SPMSD Investigational Site 164
🇫🇷Essey Les Nancy, France
SPMSD Investigational Site 160
🇫🇷Collombey Les Belles, France
SPMSD Investigational Site 153
🇫🇷Marseille, France
SPMSD Investigational Site 123
🇫🇷Essey Les Nancy, France
SPMSD Investigational Site 162
🇫🇷Collombey Les Belles, France
SPMSD Investigational Site 133
🇫🇷Ostwald, France
SPMSD Investigational Site 152
🇫🇷Saint Ouen, France
SPMSD Investigational Site 193
🇫🇷Draguignan, France
SPMSD Investigational Site 114
🇫🇷Frouard, France
SPMSD Investigational Site 151
🇫🇷Quimper, France
SPMSD Investigational Site 134
🇫🇷Montpellier, France
SPMSD Investigational Site 198
🇫🇷Le Havre, France
SPMSD Investigational Site 107
🇫🇷Lingolsheim, France
SPMSD Investigational Site 113
🇫🇷Illkirch Graffenstaden, France
SPMSD Investigational Site 115
🇫🇷Louverne, France
SPMSD Investigational Site 199
🇫🇷Rouen, France
SPMSD Investigational Site 197
🇫🇷Le Havre, France