Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
NCT ID: NCT01262924
Last Updated: 2010-12-17
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
PHASE3
116 participants
INTERVENTIONAL
1997-10-31
1998-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group A
dTPa vaccine
GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Intramuscular, single dose
Group B
Pa vaccine
GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Intramuscular, single dose
Group C
Tedivax-Adult™/ Td-Rix™
Tedivax-Adult™/ Td-Rix™
Intramuscular, single dose or 2 doses (in the annex phase)
Interventions
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GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Intramuscular, single dose
GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Intramuscular, single dose
Tedivax-Adult™/ Td-Rix™
Intramuscular, single dose or 2 doses (in the annex phase)
Eligibility Criteria
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Inclusion Criteria
* Free of obvious health problems as established by medical history and clinical examination before entering into the study
* Written informed consent obtained from the subject
* If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria
* Vaccination against pertussis since childhood
* History of diphtheria and/or tetanus
* Known history of pertussis within the previous five years
* Known exposure to diphtheria or pertussis within the previous five years
* Known history of non-response to diphtheria, tetanus or pertussis vaccine
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine
* Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after
* Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period
* Any confirmed or suspected immunosuppressive or immunodeficient condition
* Pregnant or lactating female
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
* Hypersensitivity to any component of the vaccines
* Acute disease at the time of enrolment
* Oral temperature of ≥37.5°C (99.5°F)
* Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines
* An immediate anaphylactic reaction
* Signs of encephalopathy
* Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:
* Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause
* Collapse or shock-like state within 48 hours of vaccination
* Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination
* Convulsions with or without fever, occurring within 3 days of vaccination
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
References
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Van Damme P, Burgess M. Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults. Vaccine. 2004 Jan 2;22(3-4):305-8. doi: 10.1016/j.vaccine.2003.08.012.
Other Identifiers
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263855/003
Identifier Type: -
Identifier Source: org_study_id