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Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine

Primary Purpose

Diphteria, Tetanus and Pertussis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Tedivax-Adult™/ Td-Rix™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphteria, Tetanus and Pertussis focused on measuring Booster vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A male or female aged ≥18 years at the time of vaccination
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study
  • Written informed consent obtained from the subject
  • If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..

Exclusion Criteria:

  • Vaccination against diphtheria and/or tetanus within the previous five years
  • Vaccination against pertussis since childhood
  • History of diphtheria and/or tetanus
  • Known history of pertussis within the previous five years
  • Known exposure to diphtheria or pertussis within the previous five years
  • Known history of non-response to diphtheria, tetanus or pertussis vaccine
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine
  • Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after
  • Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • Pregnant or lactating female
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  • Hypersensitivity to any component of the vaccines
  • Acute disease at the time of enrolment
  • Oral temperature of ≥37.5°C (99.5°F)
  • Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines
  • An immediate anaphylactic reaction
  • Signs of encephalopathy
  • Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:
  • Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause
  • Collapse or shock-like state within 48 hours of vaccination
  • Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination
  • Convulsions with or without fever, occurring within 3 days of vaccination

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    dTPa vaccine

    Pa vaccine

    Tedivax-Adult™/ Td-Rix™

    Outcomes

    Primary Outcome Measures

    Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)

    Secondary Outcome Measures

    Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
    Occurrence of solicited local adverse experiences
    Occurrence of solicited general adverse experiences
    Occurrence of unsolicited symptoms
    Occurrence of any serious adverse experiences
    Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
    Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)

    Full Information

    First Posted
    December 16, 2010
    Last Updated
    December 16, 2010
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01262924
    Brief Title
    Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
    Official Title
    A Phase III, Blinded, Randomised, Monocentre, Comparative Clinical Study of the Immunogenicity, Reactogenicity and Safety of a Single Booster Dose of SB Biologicals' Candidate dTpa and pa Vaccines and SB Biologicals' Licensed Td Vaccine in Healthy Adults Aged ≥18 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1997 (undefined)
    Primary Completion Date
    December 1998 (Actual)
    Study Completion Date
    December 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diphteria, Tetanus and Pertussis
    Keywords
    Booster vaccination

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    116 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    dTPa vaccine
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Pa vaccine
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    Tedivax-Adult™/ Td-Rix™
    Intervention Type
    Biological
    Intervention Name(s)
    GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
    Intervention Description
    Intramuscular, single dose
    Intervention Type
    Biological
    Intervention Name(s)
    GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
    Intervention Description
    Intramuscular, single dose
    Intervention Type
    Biological
    Intervention Name(s)
    Tedivax-Adult™/ Td-Rix™
    Intervention Description
    Intramuscular, single dose or 2 doses (in the annex phase)
    Primary Outcome Measure Information:
    Title
    Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
    Time Frame
    One month after the booster dose (Month 1)
    Secondary Outcome Measure Information:
    Title
    Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
    Time Frame
    One month after the booster dose (Month 1)
    Title
    Occurrence of solicited local adverse experiences
    Time Frame
    During the 15-day (Day 0-14) follow-up period after vaccination
    Title
    Occurrence of solicited general adverse experiences
    Time Frame
    During the 15-day (Day 0-14) follow-up period after vaccination
    Title
    Occurrence of unsolicited symptoms
    Time Frame
    Within the 31-day (Day 0 -30) follow-up period after vaccination
    Title
    Occurrence of any serious adverse experiences
    Time Frame
    Within the 31-day (Day 0 -30) follow-up period after vaccination
    Title
    Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
    Time Frame
    At pre-vaccination (Day 0) and Month 1 post-vaccination
    Title
    Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Time Frame
    One month after the second and third booster dose (Month 12)
    Title
    Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Time Frame
    During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
    Title
    Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Time Frame
    During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
    Title
    Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Time Frame
    Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
    Title
    Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
    Time Frame
    Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: A male or female aged ≥18 years at the time of vaccination Free of obvious health problems as established by medical history and clinical examination before entering into the study Written informed consent obtained from the subject If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid.. Exclusion Criteria: Vaccination against diphtheria and/or tetanus within the previous five years Vaccination against pertussis since childhood History of diphtheria and/or tetanus Known history of pertussis within the previous five years Known exposure to diphtheria or pertussis within the previous five years Known history of non-response to diphtheria, tetanus or pertussis vaccine Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition Pregnant or lactating female History of allergic disease or reactions likely to be exacerbated by any component of the vaccine Hypersensitivity to any component of the vaccines Acute disease at the time of enrolment Oral temperature of ≥37.5°C (99.5°F) Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines An immediate anaphylactic reaction Signs of encephalopathy Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens: Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause Collapse or shock-like state within 48 hours of vaccination Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination Convulsions with or without fever, occurring within 3 days of vaccination
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14670310
    Citation
    Van Damme P, Burgess M. Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults. Vaccine. 2004 Jan 2;22(3-4):305-8. doi: 10.1016/j.vaccine.2003.08.012.
    Results Reference
    result

    Learn more about this trial

    Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine

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