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
  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
Acellular Pertussis
Tetanus
Diphtheria
Biological: Boostrix TM
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of GSK Biologicals' dTpa Booster Vaccine in Young Adults 10 Years After Previous dTpa Boosting.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects who had received the dTpa vaccine in the primary study (263855/004)
Biological: Boostrix TM
Single booster dose of vaccine
Other Name: dTpa vaccine
Experimental: Group B
Subjects who had received the Td + pa vaccines in the primary study (263855/004)
Biological: Boostrix TM
Single booster dose of vaccine
Other Name: dTpa vaccine

Detailed Description:

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009
Mertsola J et al. Decennial administration of reduced-antigen dTpa vaccine in young adults - incidence of solicited local symptoms classified by pre-vaccination antibody concentrations. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00610168     History of Changes
Other Study ID Numbers: 110806
Study First Received: January 25, 2008
Last Updated: April 3, 2014
Health Authority: Finland: National Agency of Medicines

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

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Pentetic Acid
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents

ClinicalTrials.gov processed this record on August 28, 2014