Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Poliomyelitis, PENTAXIM™, TETRAXIM™
Brief summary
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
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).
Interventions
BIOLOGICALDTacP-IPV combined vaccine (TETRAXIM™)
0.5 mL, Intramuscular
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination. | 30 days post-vaccination |
Secondary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety after booster administration of TETRAXIM™. | 30 days post-vaccination and entire study period |
Countries
Thailand
Outcome results
None listed