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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

June 21, 2007
May 1, 2014
June 2007
September 2007   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00489970 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Persistence Study of GSK Bio's Tdap Vaccine 1, 3, 5 and 10 Years After Administration as a Single Dose in 106316 Study
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Acellular Pertussis
  • Tetanus
  • Diphtheria
  • 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.
  • Biological: Adacel
    A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.
  • 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.
    Interventions:
    • Procedure: Taking of blood samples
    • Biological: Boostrix
  • 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.
    Interventions:
    • Procedure: Taking of blood samples
    • Biological: Adacel
Weston W, Messier M, Friedland LR, Wu X, Howe B. Persistence of antibodies 3 years after booster vaccination of adults with combined acellular pertussis, diphtheria and tetanus toxoids vaccine. Vaccine. 2011 Nov 3;29(47):8483-6. Epub 2011 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1592
April 2015
September 2007   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00489970
110080, 110082, 110084, 110086
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP