Tetanus Clinical Trial
Official title:
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
Verified date | October 2011 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ministry of Public Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 123 |
Est. completion date | January 2011 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 6 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination. | 30 days post-vaccination | No | |
Secondary | To provide information concerning the safety after booster administration of TETRAXIM™. | 30 days post-vaccination and entire study period | Yes |
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