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Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00610168
  Purpose

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.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Biological: Boostrix
Phase IV

MedlinePlus related topics:   Diphtheria    Tetanus    Whooping Cough   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:   Evaluation of GSK Bio's dTpa Booster Vaccine in Young Adults 10 Years After Previous dTpa Boosting.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-diphtheria antibody concentrations [ Time Frame: One month after the booster dose ]
  • Anti-tetanus antibody concentrations [ Time Frame: One month after the booster dose ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   509
Study Start Date:   January 2008
Primary Completion Date:   April 2008 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   20 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610168

Locations
Finland
GSK Investigational Site    
      Turku, Finland, 20520

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials     GlaxoSmithKline    
  More Information


Responsible Party:   GSK ( Study Director )
Study ID Numbers:   110806
First Received:   January 25, 2008
Last Updated:   October 9, 2008
ClinicalTrials.gov Identifier:   NCT00610168
Health Authority:   Finland: National Agency of Medicines

Keywords provided by GlaxoSmithKline:
Tdap  
dTpa vaccine  
booster  
Boostrix  
diphtheria
tetanus
pertussis

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough
Diphtheria
Clostridium Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:
Bordetella Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on October 15, 2008




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