GSK: Protocol Summary for 111413

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Protocol Summary for 111413

Protocol Summary
Protocol Id:	111413
Secondary Ids:	N/A
Title:	Evaluation of GSK Biologicals’ Boostrix® vaccine when compared with Decavac™ in adults aged 65 years or older.
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CBER
IND/IDE Number:	BB IND 8641
IND/IDE Serial Number:	125
Has Expanded Access?:	no
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration
Collaborators:	N/A
Brief Summary:	This phase IIIb, observer-blind study will evaluate the immunogenicity and safety of GSK Biologicals’ Boostrix® vaccine in adults (extending indication) aged 65 years or older.
Detailed Description:
Record Verification Date:	February 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	February 2009
Study Completion Date:	July 2009
Study Completion Date Type:	Actual
Primary Completion Date:	July 2009
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	yes
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value One month after vaccination Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration Before (PRE) and one month after vaccination (POST)
Secondary Outcomes:	Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off One month after vaccination Number of Subjects Reporting Solicited General Symptoms Within the 4-day (Day 0-3) post-vaccination period Anti-T and Anti-D Antibody Concentrations One month after vaccination Number of Subjects Reporting Solicited Local Symptoms Within the 4-day (Day 0-3) post-vaccination period Number of Subjects Reporting Unsolicited Adverse Events (AE) Within the 31-day (Day 0-30) post-vaccination period Number of Subjects Reporting Serious Adverse Events (SAE) From the vaccintation up to Day 182 Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions One month after vaccination Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off One month after vaccination
Conditions:	Diphtheria Diphtheria-Tetanus-acellular Pertussis Vaccines Tetanus Pertussis
Keywords:	Boostrix® adults
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: • Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study. • Males or females 65 years of age and older at the time of study entry. • Free of an acute aggravation of the health status as established by medical history and medical history and clinical examination before entering into the study. • Written informed consent from all subjects. Exclusion Criteria: • Administration of a diphtheria-tetanus (Td) booster within the previous 5 years. • Administration of a Tdap vaccine at any time prior to study entry. • History of diphtheria and/or tetanus and/or pertussis disease. • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period. • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination. • Planned administration of any vaccine not foreseen by the study protocol up to 30 days following vaccination, with the exception of influenza, vaccine, which may be administered at any time up to or during the study period, including the day of study vaccination. Pneumococcal and zoster vaccines can be administered at the discretion of the investigator when the subject comes back at Visit 2. • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination or planned administration during the study period. • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. • History of serious allergic reaction following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines. • History of encephalopathy within seven days of administration of a previous booster dose of pertussis vaccine that is not attributable to another identifiable cause. • Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests. • Acute disease at the time of vaccination. • Administration of immunoglobulins and/or any blood products within the three months preceding vaccination, or planned administration during the study period. • Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
Gender:	Both
Minimum Age:	65 Year
Maximum Age:
Enrollment:	1332
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	US GSK Clinical Trials Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:
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:	Click to view location information United States (click to view all sites in United States) Arizona (click to view) GSK Investigational Site Tucson, Arizona, 85741; COMPLETED; California (click to view) GSK Investigational Site Los Angeles, California, 90057; COMPLETED; Florida (click to view) GSK Investigational Site West Palm Beach, Florida, 33409; COMPLETED; GSK Investigational Site Deland, Florida, 32720; COMPLETED; Georgia (click to view) GSK Investigational Site Stockbridge, Georgia, 30281; COMPLETED; Indiana (click to view) GSK Investigational Site Indianapolis, Indiana, 46254; COMPLETED; Kansas (click to view) GSK Investigational Site Pratt, Kansas, 67124; COMPLETED; Kentucky (click to view) GSK Investigational Site Lexington, Kentucky, 40509; COMPLETED; Louisiana (click to view) GSK Investigational Site Metairie, Louisiana, 70006; COMPLETED; Maryland (click to view) GSK Investigational Site Elkridge, Maryland, 21075; COMPLETED; GSK Investigational Site Columbia, Maryland, 21045; COMPLETED; Massachusetts (click to view) GSK Investigational Site Milford, Massachusetts, 01757; COMPLETED; Michigan (click to view) GSK Investigational Site Stevensville, Michigan, 49127; COMPLETED; North Carolina (click to view) GSK Investigational Site Wilmington, North Carolina, 28401; COMPLETED; GSK Investigational Site High Point, North Carolina, 27262; COMPLETED; Ohio (click to view) GSK Investigational Site Wandsworth, Ohio, 44281; COMPLETED; GSK Investigational Site Cleveland, Ohio, 44122; COMPLETED; GSK Investigational Site Mogadore, Ohio, 44260; COMPLETED; South Carolina (click to view) GSK Investigational Site Mount Pleasant, South Carolina, 29464; COMPLETED; Tennessee (click to view) GSK Investigational Site Bristol, Tennessee, 37620; COMPLETED; Texas (click to view) GSK Investigational Site Fort Worth, Texas, 76135; COMPLETED; Utah (click to view) GSK Investigational Site West Jordan, Utah, 84088; COMPLETED; Virginia (click to view) GSK Investigational Site Williamsburg, Virginia, 23185; COMPLETED; Washington (click to view) GSK Investigational Site Wenatchee, Washington, 98801; COMPLETED;

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Protocol Summary for 111413