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Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

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ClinicalTrials.gov Identifier: NCT00385255
Recruitment Status : Completed
First Posted : October 9, 2006
Results First Posted : September 17, 2018
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Acellular Pertussis Diphtheria Tetanus Biological: Fluarix® Biological: Boostrix® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1726 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Study to Evaluate Immunogenicity and Safety of Boostrix When Co-administered With Fluarix in Subjects 19 Years of Age and Older
Actual Study Start Date : October 23, 2006
Actual Primary Completion Date : February 28, 2007
Actual Study Completion Date : February 28, 2007


Arm Intervention/treatment
Experimental: BOOSTRIX+FLUARIX GROUP
Healthy 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.
Biological: Fluarix®
GSK Biologicals' inactivated influenza split virus vaccine.

Biological: Boostrix®
GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Experimental: FLUARIX BOOSTRIX GROUP
Healthy 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.
Biological: Fluarix®
GSK Biologicals' inactivated influenza split virus vaccine.

Biological: Boostrix®
GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.




Primary Outcome Measures :
  1. Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens [ Time Frame: At Month 1 post-Boostrix® vaccination ]
    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.

  2. Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value [ Time Frame: At Month 1 post-Boostrix® vaccination ]
    The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).

  3. Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens [ Time Frame: At Month 1 post-Boostrix® vaccination ]
    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).

  4. Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza [ Time Frame: At Month 1 post-Fluarix® vaccination ]
    The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.

  5. Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B [ Time Frame: At Month 1 post-Fluarix® vaccination ]
    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.


Secondary Outcome Measures :
  1. Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value [ Time Frame: At Month 1 post-Boostrix® vaccination ]
    A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL.

  2. Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) [ Time Frame: At Day 0 and Month 1 post-Boostrix® vaccination ]
    Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL).

  3. Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) [ Time Frame: At Day 0 and Month 1 post-Boostrix® vaccination ]
    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).

  4. Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens [ Time Frame: At Month 1 post-Boostrix® vaccination ]
    Booster responses for anti-D and anti-T antibodies are defined as: For initially seronegative subjects [pre-vaccination concentration below (<) cut-off 0.1 IU/mL]: antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL), one month after vaccination with Boostrix®; For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with Boostrix®.

  5. Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens [ Time Frame: At Month 1 post-Boostrix® vaccination ]
    Booster responses for anti-PT, anti-FHA and anti-PRN are defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL), one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with Boostrix®.

  6. Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers [ Time Frame: At Month 1 post-Fluarix® vaccination ]
    Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs).

  7. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.

  8. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months ]
    Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain, muscle aches and shivering. Any = occurrence of the symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.

  9. Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day period (Day 0-30) following each vaccination, up to 2 months ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  10. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: Throughout the whole study period (from Day 0 to Month 2) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385255


Locations
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United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35802
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Mesa, Arizona, United States, 85213
GSK Investigational Site
Phoenix, Arizona, United States, 85014
United States, Florida
GSK Investigational Site
Inverness, Florida, United States, 34452
GSK Investigational Site
Melbourne, Florida, United States, 32935
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Illinois
GSK Investigational Site
Peoria, Illinois, United States, 61602
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15220
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77024
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106323
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 106323
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106323
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106323
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106323
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106323
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00385255     History of Changes
Other Study ID Numbers: 106323
First Posted: October 9, 2006    Key Record Dates
Results First Posted: September 17, 2018
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Immunogenicity,
Influenza
Co-administration,
Tdap,

Additional relevant MeSH terms:
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Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs