Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

Study Overview
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Brief Summary
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The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations. Primary Objective : To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age. Secondary Objectives : To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age. To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age. To describe the safety after the booster dose of the study vaccine.

Detailed Description
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All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age. Participants will receive the study vaccine [sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)] at 4 to 6 years of age (at visit 1).

Official Title
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Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given as a Booster Dose at 4 to 6 Years of Life in Children Previously Vaccinated With PENTAXIM™ in the Study E2I34

Conditions
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Diphtheria, Tetanus, Pertussis, Poliomyelitis

Intervention / Treatment
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* Biological: DTacP-IPV combined vaccine (TETRAXIM™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Aged 4-6 years inclusive on the day of inclusion Child having completed the three-dose vaccination and the booster vaccination with DTacP-IPV//PRP T combined vaccine (PENTAXIM™) of the study E2I34 Informed consent form signed by the parent(s) or other legal representative Able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria : Participation in another clinical trial in the 4 weeks preceding the trial inclusion Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins) Any vaccination in the 4 weeks preceding the trial vaccination History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human immunodeficiency virus (HIV) infection Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34 Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current major neurological diseases or seizures Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion. Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine, temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection, hypotonic hyporesponsive episode within 48 hours following vaccine injection, seizures with or without fever within 3 days following vaccine injection.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br> | Biological: DTacP-IPV combined vaccine (TETRAXIM™)<br>* 0.5 mL, Intramuscular<br>* Other names: TETRAXIM™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination. |  | 30 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety after booster administration of TETRAXIM™. |  | 30 days post-vaccination and entire study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphtheria, Tetanus, Pertussis, Poliomyelitis, PENTAXIM™, TETRAXIM™