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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
| Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
| Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
| Completed |
NCT02538211 -
The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
|
N/A | |
| Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
| Completed |
NCT01689324 -
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents
|
Phase 1/Phase 2 | |
| Completed |
NCT01444781 -
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
|
Phase 3 | |
| Completed |
NCT01214889 -
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
|
Phase 3 | |
| Completed |
NCT00804284 -
Database Surveillance Safety Study of PENTACEL® Vaccine
|
N/A | |
| Completed |
NCT00514709 -
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
|
Phase 3 | |
| Completed |
NCT00534833 -
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
|
Phase 3 | |
| Completed |
NCT00379977 -
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
|
Phase 3 | |
| Completed |
NCT00772369 -
Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
|
Phase 4 | |
| Completed |
NCT00879827 -
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
|
Phase 3 | |
| Completed |
NCT01457495 -
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
|
Phase 2 | |
| Completed |
NCT01267058 -
Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
|
Phase 3 | |
| Completed |
NCT02853929 -
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
|
Phase 4 | |
| Completed |
NCT02858440 -
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
|
Phase 3 | |
| Recruiting |
NCT06049940 -
Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population
|
Phase 3 | |
| Completed |
NCT00385255 -
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
|
Phase 3 |