Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
NCT ID: NCT01267058
Last Updated: 2010-12-24
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
550 participants
INTERVENTIONAL
1997-09-30
1998-02-28
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
Subjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine
Intramuscular, single dose
Group B
Subjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
GSK Biologicals' acellular pertussis vaccine
Intramuscular, single dose
Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Intramuscular, single dose
Group C
Subjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine
GSK Biologicals' acellular pertussis vaccine
Intramuscular, single dose
Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Intramuscular, single dose
Interventions
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GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine
Intramuscular, single dose
GSK Biologicals' acellular pertussis vaccine
Intramuscular, single dose
Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Intramuscular, single dose
Eligibility Criteria
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Inclusion Criteria
* Written informed consent has been obtained
Exclusion Criteria
* History of diphtheria or tetanus vaccination within the past 5 years Females must not be pregnant or lactating They must either surgically sterilized or one year post-menopausal or if they are of childbearing potential, they must be abstinent or have used adequate contraceptive precautions (or one month prior to the booster vaccination, and must agree to continue such precautions for 2 months after completion of the vaccination.
* History of diphtheria or tetanus disease
* History of allergic disease likely to be stimulated by the vaccination
* Major congenital defects or serious chronic illness
* History of progressive neurological disease
* Immunosuppressive therapy
* Any suspected or confirmed immune disorder
* Immunoglobulin therapy or administration of any blood products within the previous three months or during the study period
* Acute febrile illness (\>37.5°C, axillary or oral temperature) at the time of planned vaccination
* Administration of an investigational or non registered drug or vaccine within 30 days prior to the start of the present trial
* Simultaneous administration of a vaccine not foreseen by the study protocol, within 30 days prior to the start of the present trial
* Any severe or serious adverse experience having occurred after previous administration of DTP vaccine i.e:
* an immediate anaphylactic or unacceptable reaction to the investigator's opinion, to a previous dose of diphtheria tetanus pertussis whole-cell vaccine, i.e. :
* encephalopathy
* fever \> 40.5°C (105°F), rectal temperature, occurring after vaccination with diphtheria tetanus pertussis whole-cell vaccine and not due to another identifiable cause.
* collapse or shock-like state
* persistent, inconsolable crying lasting \> 3 hours
* seizures with or without fever
* systemic allergic or neurologic reactions following a previous dose of tetanus and diphtheria toxoids vaccine
* Exclusion from long term follow-up of antibody persistence : Evidence of confirmed pertussis, diphtheria or tetanus disease or vaccination against these diseases since previous study visit
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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Cheuvart B, Burgess M, Zepp F, Mertsola J, Wolter J, Schuerman L. Anti-diphtheria antibody seroprotection rates are similar 10 years after vaccination with dTpa or DTPa using a mathematical model. Vaccine. 2004 Dec 2;23(3):336-42. doi: 10.1016/j.vaccine.2004.06.012.
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.
Turnbull FM, Heath TC, Jalaludin BB, Burgess MA, Ramalho AC. A randomized trial of two acellular pertussis vaccines (dTpa and pa) and a licensed diphtheria-tetanus vaccine (Td) in adults. Vaccine. 2000 Nov 8;19(6):628-36. doi: 10.1016/s0264-410x(00)00252-8.
McIntyre PB, Burgess MA, Egan A, Schuerman L, Hoet B. Booster vaccination of adults with reduced-antigen-content diphtheria, Tetanus and pertussis vaccine: immunogenicity 5 years post-vaccination. Vaccine. 2009 Feb 11;27(7):1062-6. doi: 10.1016/j.vaccine.2008.11.102. Epub 2008 Dec 16.
Other Identifiers
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263855/002
Identifier Type: -
Identifier Source: org_study_id