Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diphtheria, Tetanus, Poliomyelitis

Intervention / Treatment
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* Biological: Diphtheria, tetanus, polio and pertussis vaccination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TETRAVAC-ACELLULAIRE<br> | Biological: Diphtheria, tetanus, polio and pertussis vaccination<br>* 1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |