GSK: Protocol Summary for 263855/002

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Protocol Summary for 263855/002

Protocol Summary
Protocol Id:	263855/002
Secondary Ids:
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
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Australia: Therapeutic Goods Administration
Collaborators:
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.
Detailed Description:
Record Verification Date:	December 2010
Status:	Completed
Why Study Stopped:
Study Start Date:	September 1997
Study Completion Date:	February 1998
Study Completion Date Type:	Actual
Primary Completion Date:	February 1998
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Single Blind
Masked Subject:	yes
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety Study
Primary Outcomes:	Occurrence of solicited local and general symptoms Within the 15-day (Day 0 – Day 14) follow-up period after the first injection
Secondary Outcomes:	Immunogenicity with respect to components of the study vaccines Immediately prior to the booster vaccination Occurrence of serious adverse experiences to vaccination Within 31 days (Day 0 – Day 30) after each vaccine administration Occurrence of unsolicited symptoms Within 31 days (Day 0 – Day 30) after each vaccine administration Immunogenicity with respect to components of the study vaccines 2, 3, 4 and 5 years after the vaccination Occurrence of solicited local symptoms and fever Within the 15-day (Day 0 – Day 14) follow-up period after the second injection Immunogenicity with respect to components of the study vaccines One month after the first injection Immunogenicity with respect to components of the study vaccines One month after the second injection Immunogenicity with respect to components of the study vaccines One year after the vaccination in a subset of subjects from all the groups Occurrence of general solicited symptoms to vaccination, other than fever Within the 15-day (Day 0 – Day 14) follow-up period after each vaccine administration
Conditions:	Diphtheria Tetanus Pertussis
Keywords:	Booster vaccination
Eligibility Criteria:	Click to view inclusion/exclusion 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:	Both
Minimum Age:	18 Year
Maximum Age:
Enrollment:	550
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	No locations currently recruiting for this study.

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Protocol Summary for 263855/002