Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age
NCT ID: NCT01031303
Last Updated: 2011-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
123 participants
INTERVENTIONAL
2009-12-31
2011-01-31
Brief Summary
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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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Participants will receive the study vaccine \[sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)\] at 4 to 6 years of age (at visit 1).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Study Group
DTacP-IPV combined vaccine (TETRAXIM™)
0.5 mL, Intramuscular
Interventions
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DTacP-IPV combined vaccine (TETRAXIM™)
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
6 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
sanofi pasteur SA
Locations
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Bangkok, , Thailand
Bangkok, , Thailand
Countries
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References
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Pancharoen C, Chotpitayasunondh T, Chuenkitmongkol S, Ortiz E. Long-term immunogenicity assessment of a DTaP-IPV//PRP-T vaccine given at 2, 4, 6 and 18-19 months of age, and immunogenicity and safety of a DTaP-IPV vaccine given as a booster dose at 4 to 6 years of age in Thai children. Southeast Asian J Trop Med Public Health. 2012 May;43(3):687-98.
Related Links
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Related Info
Other Identifiers
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UTN: U1111-1112-2680
Identifier Type: OTHER
Identifier Source: secondary_id
E2I57
Identifier Type: -
Identifier Source: org_study_id