Clinical Trial: Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Persistence Study of GSK Biologicals' Tdap Vaccine (776423), 1, 3, 5 and 9 Years Following Administration as a Single Dose in NCT00346073 Study and to Evaluate the Immunogenicity and Safety of Boostri

Brief Summary:

The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study.

This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).


Detailed Summary:

Subjects were previously vaccinated with either Boostrix or a control Tdap vaccine (Sanofi Pasteurs' Adacel) in study NCT00346073. Only subjects who were part of the primary study will be invited to participate in this study. All subjects will receive a single dose of Boostrix at Visit 6 (Day 0) and subjects will be observed till Visit 7 (Day 30) for safety in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period). A blood sample will be collected from all subjects before vaccination (Visit 6) and one month after vaccination (Visit 7) for antibodies estimation.

This summary has been updated following Protocol amendment 1 dated 09 November 2010, amendment 2 dated 18 February 2014, and amendment 3 dated 10 December 2014. The protocol was amended first due to the following reasons:

  1. The maximum window period allowed for the return of subjects for the Year 5 and Year 10 follow-up visits (Visit 5 and Visit 6) was extended from ± 5 weeks to ± 8 weeks.
  2. The contact details for reporting of SAEs were clarified.
  3. Text pertaining to the reporting of spontaneous abortion was removed from the protocol.
  4. The number of attempts to contact subjects who did not return for scheduled persistence visits was clarified.

The main purpose of protocol amendment 2 is to evaluate the immunogenicity and safety of Boostrix as a second dose of Tdap vaccine when administered 8 years after an initial dose of Tdap. The Year 10 time point for evaluation of persistence has been cancelled because it is no longer feasible to conduct after
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 9 years following vaccination ]
  • 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 ]
    Anti-T cut-off was defined as greater than or equal to 0.1 IU/mL (ELISA).
  • Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 9 years following vaccination ]
  • 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 ]
    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) or VERO.


Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Anti-T antibody concentration is expressed as GMC in IU/mL.
  • Anti-PT Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ]
    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 ]
    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 ]
    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: 9 years following vaccination ]
  • Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 9 years following vaccination ]
  • Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 9 years following vaccination ]
  • Anti-D Antibody Concentration [ Time Frame: 9 years following vaccination ]
  • Anti-T Antibody Concentration [ Time Frame: 9 years following vaccination ]
  • Anti-PT Antibody Concentration [ Time Frame: 9 years following vaccination ]
  • Anti-FHA Antibody Concentration [ Time Frame: 9 years following vaccination ]
  • Anti-PRN Antibody Concentration [ Time Frame: 9 years following vaccination ]


Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: June 21, 2007
Date Started: June 2007
Date Completion:
Last Updated: May 26, 2016
Last Verified: May 2016