Status:
COMPLETED
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Tetanus
Eligibility:
All Genders
20-24 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only subjects who re...
Detailed Description
This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004.
- A male or female subject, recruited 10 years after booster vaccination in study 263855/004.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
- Written informed consent obtained from the subject.
Exclusion
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination or planned administration during the active study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004.
- History of documented diphtheria, tetanus, or pertussis diseases.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :
- hypersensitivity reaction to any component of the vaccine,
- encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
- fever \>= 40°C within 48 hours of vaccination not due to another identifiable cause,
- collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
- convulsions with or without fever, occurring within 3 days of vaccination.
- Acute disease at the time of enrolment.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2008
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00610168
Start Date
January 1 2008
End Date
April 30 2008
Last Update
June 6 2018
Active Locations (1)
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1
GSK Investigational Site
Turku, Finland, 20520