Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
A Study to Evaluate Immunogenicity and Safety of Boostrix When Co-administered With Fluarix in Subjects 19 Years of Age and Older
1 other identifier
interventional
1,726
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2006
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 9, 2006
CompletedStudy Start
First participant enrolled
October 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2007
CompletedResults Posted
Study results publicly available
September 17, 2018
CompletedJune 10, 2019
June 1, 2019
4 months
October 6, 2006
January 25, 2017
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.
At Month 1 post-Boostrix® vaccination
Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value
The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).
At Month 1 post-Boostrix® vaccination
Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
At Month 1 post-Boostrix® vaccination
Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza
The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.
At Month 1 post-Fluarix® vaccination
Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B
Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer.
At Month 1 post-Fluarix® vaccination
Secondary Outcomes (10)
Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value
At Month 1 post-Boostrix® vaccination
Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T)
At Day 0 and Month 1 post-Boostrix® vaccination
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN)
At Day 0 and Month 1 post-Boostrix® vaccination
Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens
At Month 1 post-Boostrix® vaccination
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
At Month 1 post-Boostrix® vaccination
- +5 more secondary outcomes
Study Arms (2)
BOOSTRIX+FLUARIX GROUP
EXPERIMENTALHealthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
FLUARIX BOOSTRIX GROUP
EXPERIMENTALHealthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.
Interventions
GSK Biologicals' inactivated influenza split virus vaccine.
GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Huntsville, Alabama, 35802, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Inverness, Florida, 34452, United States
GSK Investigational Site
Melbourne, Florida, 32935, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15220, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Houston, Texas, 77024, United States
Related Publications (2)
Weston WM, Chandrashekar V, Friedland LR, Howe B. Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Hum Vaccin. 2009 Dec;5(12):858-66. doi: 10.4161/hv.9961. Epub 2009 Dec 31.
PMID: 19838080BACKGROUNDWeston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31.
PMID: 22212127BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 9, 2006
Study Start
October 23, 2006
Primary Completion
February 28, 2007
Study Completion
February 28, 2007
Last Updated
June 10, 2019
Results First Posted
September 17, 2018
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.