Persistence Study of GSK Bio's Tdap Vaccine 1, 3, 5 and 10 Years After Administration as a Single Dose in 106316 Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00489970
First received: June 21, 2007
Last updated: May 1, 2014
Last verified: April 2014
  Purpose

This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3, 5 and 10. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00346073).

This study will provide information regarding the persistence of antibodies to diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens, up to 10 years following vaccination with GSK Bio's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed.


Condition Intervention Phase
Acellular Pertussis
Tetanus
Diphtheria
Procedure: Taking of blood samples
Biological: Boostrix
Biological: Adacel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IIIb, Controlled, Multicenter Study to Evaluate Antibody Persistence at 1, 3, 5 and 10 Years Following Administration of a Single Dose of Tdap Vaccine to Healthy Subjects, 19 Years of Age and Older in the Study 106316

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    Anti-D cut-off was defined as greater than or equal to 0.1 international units per mililiter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA).

  • Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    Anti-T cut-off was defined as greater than or equal to 0.1 IU/mL.

  • Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    The cut-off for anti-PT concentrations was defined as equal to or greater than 5 ELISA units per mililiter (EL.U/mL).

  • Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.

  • Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.

  • Anti-D Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.

  • Anti-T Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    Anti-T antibody concentration is expressed as GMC in IU/mL.

  • Anti-PT Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    Anti-PT antibody concentration is expressed as GMC in EL.U/mL.

  • Anti-FHA Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    Anti-FHA antibody concentration is expressed as GMC in EL.U/mL.

  • Anti-PRN Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
    Anti-PRN antibody concentration is expressed as GMC in EL.U/mL.

  • Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Anti-D Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Anti-T Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Anti-PT Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Anti-FHA Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
  • Anti-PRN Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]

Enrollment: 1592
Study Start Date: June 2007
Estimated Study Completion Date: April 2015
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boostrix Group
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
Procedure: Taking of blood samples
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination.
Biological: Boostrix
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
Active Comparator: Adacel Group
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
Procedure: Taking of blood samples
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination.
Biological: Adacel
A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.

Detailed Description:

Open, multicenter study with the same two parallel groups as in the primary study (NCT00346073). No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination. Subjects were randomized (2:1 ratio) in the primary study and will not be further randomized during this persistence phase. This protocol posting is updated in order to comply with the FDA AA, Sep 2007.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects who received study vaccination (GSK776423 or Adacel) in the primary study (NCT00346073) will be considered eligible to participate in this study.
  • Written informed consent must be obtained from the subject prior to each study time point.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489970

  Hide Study Locations
Locations
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
Mesa, Arizona, United States, 85203
GSK Investigational Site
Phoenix, Arizona, United States, 85014
GSK Investigational Site
Tempe, Arizona, United States, 85283
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
San Diego, California, United States, 92103-6204
GSK Investigational Site
San Diego, California, United States, 92108
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
GSK Investigational Site
Pueblo, Colorado, United States, 81001
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20006
United States, Florida
GSK Investigational Site
Melbourne, Florida, United States, 32935
GSK Investigational Site
Miami, Florida, United States, 33143
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83704
United States, Illinois
GSK Investigational Site
Peoria, Illinois, United States, 61602
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Michigan
GSK Investigational Site
Richland, Michigan, United States, 49083
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
North Platte, Nebraska, United States, 69101
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Tabor City, North Carolina, United States, 28463
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Grove City, Pennsylvania, United States, 16127
GSK Investigational Site
Johnstown, Pennsylvania, United States, 15904
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29412
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77024
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
West Jordan, Utah, United States, 84088
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00489970     History of Changes
Other Study ID Numbers: 110080, 110082, 110084, 110086
Study First Received: June 21, 2007
Results First Received: July 15, 2010
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Persistence
immunogenicity

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on August 28, 2014