Status:
COMPLETED
Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphteria, Tetanus and Pertussis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussi...
Eligibility Criteria
Inclusion
- A male or female aged ≥18 years at the time of vaccination
- 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.
- For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..
Exclusion
- Vaccination against diphtheria and/or tetanus within the previous five years
- 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
Key Trial Info
Start Date :
October 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 1998
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01262924
Start Date
October 1 1997
End Date
December 1 1998
Last Update
December 17 2010
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