Brief Title
Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
Official Title
Single-blind, Clinical Study of the Immunogenicity and Reactogenicity of SB Biologicals' dTpa, pa Vaccines and a Td Vaccine, Given as a Booster Dose to Healthy Adults, From the Age of 18 Years Onwards
Brief Summary
The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline
Biologicals' (formerly known as SmithKline Beecham Biologicals) combined
diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards,
in Australia.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Occurrence of solicited local and general symptoms
Secondary Outcome
Immunogenicity with respect to components of the study vaccines
Condition
Diphtheria
Intervention
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine
Study Arms / Comparison Groups
Group A
Description: Subjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
550
Start Date
September 1997
Completion Date
February 1998
Primary Completion Date
February 1998
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age at the time of the vaccination
- Written informed consent has been obtained
Exclusion Criteria:
- Evidence of confirmed pertussis disease within the previous 5 years
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
GSK Clinical Trials, ,
Administrative Informations
NCT ID
NCT01267058
Organization ID
263855/002
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, Study Director, GlaxoSmithKline
Verification Date
December 2010