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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00610168
First received: January 25, 2008
Last updated: April 3, 2014
Last verified: April 2014

January 25, 2008
April 3, 2014
January 2008
April 2008   (final data collection date for primary outcome measure)
  • Anti-diphtheria antibody concentrations in Group A [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]
  • Anti-tetanus antibody concentrations in Group A [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]
  • Anti-diphtheria antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-tetanus antibody concentrations [ Time Frame: One month after the booster dose ]
Complete list of historical versions of study NCT00610168 on ClinicalTrials.gov Archive Site
  • Anti-diphtheria antibody concentration [ Time Frame: Prior to and one month after the booster dose ] [ Designated as safety issue: No ]
  • Anti-tetanus antibody concentrations [ Time Frame: Prior to and one month after the booster dose ] [ Designated as safety issue: No ]
  • Anti-PT, anti-FHA and anti-PRN seropositivity [ Time Frame: Prior to and one month after the booster dose ] [ Designated as safety issue: No ]
  • Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations [ Time Frame: Prior to and one month after the booster dose ] [ Designated as safety issue: No ]
  • Booster response to the PT, FHA and PRN antigens [ Time Frame: Prior to and one month after the booster dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the 31-day follow-up period ] [ Designated as safety issue: No ]
  • Anti-diphtheria antibody concentration
  • Anti-tetanus antibody concentrations
  • Anti-PT, anti-FHA and anti-PRN seropositivity
  • Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations
  • Booster response to the PT, FHA and PRN antigens
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period ]
  • Occurrence of serious adverse events
Not Provided
Not Provided
 
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
Evaluation of GSK Biologicals' dTpa Booster Vaccine in Young Adults 10 Years After Previous dTpa Boosting.

The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.

This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Acellular Pertussis
  • Tetanus
  • Diphtheria
Biological: Boostrix TM
Single booster dose of vaccine
Other Name: dTpa vaccine
  • Experimental: Group A
    Subjects who had received the dTpa vaccine in the primary study (263855/004)
    Intervention: Biological: Boostrix TM
  • Experimental: Group B
    Subjects who had received the Td + pa vaccines in the primary study (263855/004)
    Intervention: Biological: Boostrix TM

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004.
  • A male or female subject, recruited 10 years after booster vaccination in study 263855/004.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination or planned administration during the active study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004.
  • History of documented diphtheria, tetanus, or pertussis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :

    • hypersensitivity reaction to any component of the vaccine,
    • encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
    • fever >= 40°C within 48 hours of vaccination not due to another identifiable cause,
    • collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
    • convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
Both
20 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00610168
110806
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