Last updated: 07/17/2024 15:18:31
Evaluation of GlaxoSmithKline Biologicals’ Boostrix® vaccine in comparison with Decavac™ vaccine.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluation of GSK Biologicals’ Boostrix® vaccine when compared with Decavac™ in adults aged 65 years or older.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with antibody concentration against vaccine antigens, above a protocol defined cut-off value
Timeframe: One month after vaccination.
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration
Timeframe: Before (PRE) and one month after vaccination (POST)
Secondary outcomes:
Anti-T and Anti-D Antibody Concentrations
Timeframe: Before (PRE) and one month after vaccination (POST)
Number of Subjects With vaccine response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off
Timeframe: One month after vaccination
Number of Subjects With vaccine response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off
Timeframe: One month after vaccination
Number of Subjects With vaccine response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, using alternative definitions.
Timeframe: One month after vaccination
Number of Subjects Reporting Solicited local Symptoms
Timeframe: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Solicited General Symptoms
Timeframe: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Timeframe: Within the 31-day (Day 0-30) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
Timeframe: From the vaccination up to Day 182
Interventions:
Enrollment:
1332
Primary completion date:
2009-23-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Weston WM et al. (2012) Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix(®)): results of two randomized trials. Vaccine. 30(9):1721-1728.
Weston WM et al. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Boostrix™): results of a randomized clinical trial. Abstract presented at the 45th National Immunization Conference (NIC). Washington, USA, 28-31 March 2011.
Medical condition
Tetanus, acellular pertussis, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines
Product
SB776423
Collaborators
Not applicable
Study date(s)
February 2009 to October 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- 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.
- Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
- Administration of a Tdap vaccine at any time prior to study entry.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- 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.
Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
Trial location(s)
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Columbia, Maryland, United States, 21045
Status
Study Complete
Location
GSK Investigational Site
Elkridge, Maryland, United States, 21075
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76135
Status
Study Complete
Showing 1 - 6 of 24 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2009-23-07
Actual study completion date
2009-15-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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