Tetanus Clinical Trial
Official title:
Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE
| Verified date | September 2017 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 278 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 11 Years to 13 Years |
| Eligibility |
Inclusion Criteria: - Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | SPMSD Investigational Site 120 | Angers | |
| France | SPMSD Investigational Site 103 | Arras | |
| France | SPMSD Investigational Site 155 | Asnieres | |
| France | SPMSD Investigational Site 125 | Bersee | |
| France | SPMSD Investigational Site 121 | Besancon | |
| France | SPMSD Investigational Site 141 | Besancon | |
| 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 135 | Chalons En Champagne | |
| France | SPMSD Investigational Site 163 | Champdeniers | |
| 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 Les Nancy | |
| France | SPMSD Investigational Site 123 | Essey Les Nancy | |
| France | SPMSD Investigational Site 164 | Essey Les 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 | Louverne | |
| 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 A 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi Pasteur, a Sanofi Company |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects with an anti-diphtheria concentration =0.01 IU/mL | Pre-booster dose (Day 0) | ||
| Primary | Proportion of subjects with an anti-tetanus concentration =0.01 IU/mL | Pre-booster dose (Day 0) | ||
| Primary | Proportion of subjects with an anti-polio type 1 titer = 8 (1/dilution) | Pre-booster dose (Day 0) | ||
| Primary | Proportion of subjects with an anti-polio type 2 titer = 8 (1/dilution) | Pre-booster dose (Day 0) | ||
| Primary | Proportion of subjects with an anti-polio type 3 titer = 8 (1/dilution) | Pre-booster dose (Day 0) | ||
| Primary | Proportion of subjects with an anti-diphtheria concentration =0.1 IU/mL | 1 month post-booster dose | ||
| Primary | Proportion of subjects with an anti-tetanus concentration =0.1 IU/mL | 1 month post-booster dose | ||
| Primary | Proportion of subjects with an anti-polio type 1 titer =8 (1/dilution) | 1 month post-booster dose | ||
| Primary | Proportion of subjects with an anti-polio type 2 titer =8 (1/dilution) | 1 month post-booster dose | ||
| Primary | Proportion of subjects with an anti-polio type 3 titer =8 (1/dilution) | 1 month post-booster dose | ||
| Secondary | Geometric mean titer for diphtheria | Pre-booster (Day 0) and 1 month post-booster dose | ||
| Secondary | Geometric mean titer for tetanus | Pre-booster (Day 0) and 1 month post-booster dose | ||
| Secondary | Geometric mean titer for polio type 1 | Pre-booster (Day 0) and 1 month post-booster dose | ||
| Secondary | Geometric mean titer for polio type 2 | Pre-booster (Day 0) and 1 month post-booster dose | ||
| Secondary | Geometric mean titer for polio type 3 | Pre-booster (Day 0) and 1 month post-booster dose | ||
| Secondary | Solicited injection site and solicited systemic reactions | From Day 0 to Day 7 post vaccination | ||
| Secondary | Unsolicited injection site reactions and unsolicited systemic adverse events | From Day 0 to Day 28 days post vaccination | ||
| Secondary | Serious adverse events | From signature of informed consent up to last study visit of the subject |
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