Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine

Launched by GLAXOSMITHKLINE · Dec 16, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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