Last updated: 07/17/2024 15:09:18
Immunogenicity, safety of GSKs Tdap vaccine Boostrix when coadministered with GSKs influenza vaccine Fluarix in adults
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to evaluate immunogenicity and safety of Boostrix when co-administered with Fluarix in subjects 19 years of age and older
Trial description: The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects against diphteria (D) and tetanus (T) toxoid antigens
Timeframe: At Month 1 post-Boostrix® vaccination
Number of subjects with anti-T antibody concentrations ≥ the assay cut-off value
Timeframe: At Month 1 post-Boostrix® vaccination
Antibody concentrations against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) antigens
Timeframe: At Month 1 post-Boostrix® vaccination
Number of subjects with serum haemagglutinin inhibition (HI) titers against 3 strains of influenza
Timeframe: At Month 1 post-Fluarix® vaccination
Number of seroconverted subjects against influenza antigens H1N1, H3N2, and B
Timeframe: At Month 1 post-Fluarix® vaccination
Secondary outcomes:
Number of seropositive subjects with anti-D antibody concentrations above the cut-off value
Timeframe: At Month 1 post-Boostrix® vaccination
Antibody concentrations for diphteria toxoid (D) and tetanus toxoid (T)
Timeframe: At Day 0 and Month 1 post-Boostrix® vaccination
Antibody concentrations for pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN)
Timeframe: At Day 0 and Month 1 post-Boostrix® vaccination
Number of subjects with booster response against diphteria toxoid (D) and tetanus toxoid (T) antigens
Timeframe: At Month 1 post-Boostrix® vaccination
Number of subjects with booster response against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) antigens
Timeframe: At Month 1 post-Boostrix® vaccination
Anti-H1N1, anti-H3N2 and anti-B antibody titers
Timeframe: At Month 1 post-Fluarix® vaccination
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: During the 31-day period (Day 0-30) following each vaccination, up to 2 months
Number of subjects with serious adverse events (SAEs)
Timeframe: Throughout the whole study period (from Day 0 to Month 2)
Interventions:
Biological/vaccine: Fluarix®
Biological/vaccine: Boostrix®
Enrollment:
1726
Observational study model:
Not applicable
Primary completion date:
2007-28-02
Time perspective:
Not applicable
Clinical publications:
Weston WM et al. (2009) Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Human Vaccines. 5(12): 858-866.
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.
Medical condition
acellular pertussis, Diphtheria, Tetanus
Product
SB776423
Collaborators
Not applicable
Study date(s)
October 2006 to February 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
19+ years
Accepts healthy volunteers
Yes
- Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
- Administration of an influenza vaccine within six months prior to study entry
- Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
Exclusion criteria:
- Administration of an influenza vaccine within six months prior to 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.
- Administration 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.
- History of diphtheria and/or tetanus and/or pertussis disease.
- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.
Trial location(s)
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35802
Status
Study Complete
Location
GSK Investigational Site
Inverness, Florida, United States, 34452
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32935
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 61602
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15220
Status
Study Complete
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
Completed
Actual primary completion date
2007-28-02
Actual study completion date
2007-28-02
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.
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