Clinical trial NCT00385255: Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
Official title: A Study to Evaluate Immunogenicity and Safety of Boostrix When Co-administered With Fluarix in Subjects 19 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acellular Pertussis
Diphtheria
Tetanus
Keywords: Immunogenicity,
Influenza
Co-administration,
Tdap,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-09
Enrollment: 1726
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens
timeFrame: At Month 1 post-Boostrix® vaccination
measure: Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value
timeFrame: At Month 1 post-Boostrix® vaccination
measure: Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
timeFrame: At Month 1 post-Boostrix® vaccination
measure: Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza
timeFrame: At Month 1 post-Fluarix® vaccination
measure: Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B
timeFrame: At Month 1 post-Fluarix® vaccination
Secondary outcomes:
measure: Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value
timeFrame: At Month 1 post-Boostrix® vaccination
measure: Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T)
timeFrame: At Day 0 and Month 1 post-Boostrix® vaccination
measure: Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN)
timeFrame: At Day 0 and Month 1 post-Boostrix® vaccination
measure: Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens
timeFrame: At Month 1 post-Boostrix® vaccination
measure: Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
timeFrame: At Month 1 post-Boostrix® vaccination
measure: Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers
timeFrame: At Month 1 post-Fluarix® vaccination
measure: 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
measure: 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
measure: 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
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout the whole study period (from Day 0 to Month 2)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Inverness
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Peoria
country: United States
facility: GSK Investigational Site
state: Illinois
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Weston 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.