Status:
COMPLETED
Evaluation of Boostrix™10 Years After Previous Booster Vaccination
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Tetanus
Eligibility:
All Genders
18-28 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/0...
Detailed Description
All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present ...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029.
- Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
- Healthy subjects as established by medical history and clinical examination.
- Female subjects of non-childbearing potential may receive the booster vaccine.
- Female subjects of childbearing potential may receive the booster vaccine, if the subject:
- practices/has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- agrees to continue adequate contraception during the entire booster epoch.
Exclusion
- Exclusion criteria to be checked at study entry:
- Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.
- History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- 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 seven days following previous vaccination with pertussis-containing vaccine,
- fever \>= 40 °C (axillary temperature) within 48 hours of vaccination not due to another identifiable cause,
- collapse or shock-like state within 48 hours of vaccination,
- convulsions with or without fever, occurring within three days of vaccination.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Additional exclusion criteria to be checked for subjects before the booster vaccination administration:
- Use of any investigational or non-registered product other than the study vaccine(s) 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.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Key Trial Info
Start Date :
June 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2012
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01147900
Start Date
June 15 2010
End Date
May 8 2012
Last Update
August 20 2018
Active Locations (3)
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1
GSK Investigational Site
Brussels, Belgium, 1200
2
GSK Investigational Site
Leuven, Belgium, 3000
3
GSK Investigational Site
Wilrijk, Belgium, 2610