Status:
COMPLETED
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Tetanus
Eligibility:
All Genders
11-18 years
Phase:
PHASE4
Brief Summary
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease C...
Detailed Description
A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced diphtheria toxoid and acel...
Eligibility Criteria
Inclusion
- Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
- Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.
- Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.
Exclusion
- Administration of a pre-school booster of DTP vaccine within the previous 5 years
- Administration of a diphteria-tetanus (Td) booster within the previous 5 years
- Previous vaccination against N. meningitidis
- Hypersensitivity to latex
- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines
- History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause
- Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized
- Previous history of Guillain-Barré syndrome
Key Trial Info
Start Date :
January 25 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2006
Estimated Enrollment :
1344 Patients enrolled
Trial Details
Trial ID
NCT00282295
Start Date
January 25 2006
End Date
August 8 2006
Last Update
August 17 2018
Active Locations (24)
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1
GSK Investigational Site
Chandler, Arizona, United States, 85224
2
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
3
GSK Investigational Site
Fountain Valley, California, United States, 92708
4
GSK Investigational Site
Golden, Colorado, United States, 80401