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:
NCT00548171
First received: October 22, 2007
Last updated: March 27, 2014
Last verified: February 2011
  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 previous clinical study. Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No new recruitment will be performed in this booster phase (see inclusion criteria)


Condition Intervention Phase
Acellular Pertussis
Tetanus
Diphtheria
Biological: Boostrix™
Phase 4

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • In Group A:- Anti-diphtheria antibody concentrations [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]
  • In Group A:- Anti-tetanus antibody concentrations [ Time Frame: One month after the booster dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In all subjects:- Anti-diphtheria antibody concentration [ Time Frame: Prior to booster vaccination ] [ Designated as safety issue: No ]
  • Anti-tetanus antibody concentrations [ Time Frame: Prior to booster vaccination ] [ Designated as safety issue: No ]
  • Anti-pertussis antibody concentrations [ Time Frame: Prior to and 1 month after booster vaccination ] [ Designated as safety issue: No ]
  • Booster response to pertussis antigens [ Time Frame: One month after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after booster vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after booster vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: Following booster vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 205
Study Start Date: November 2007
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 study 263855/002
Biological: Boostrix™
Intramuscular injection, 1 dose
Active Comparator: Group B
Subjects who had received the Td + pa vaccines in either sequences (i.e. Td vaccine followed by the pa vaccine or pa vaccine followed by the Td vaccine) in study 263855/002
Biological: Boostrix™
Intramuscular injection, 1 dose

  Eligibility

Ages Eligible for Study:   28 Years and older
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 263855/002 .
  • A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination in study 263855/002.
  • 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 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 booster vaccination.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) 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 diphtheria, tetanus or pertussis since the last dose received in study 263855/002
  • History of 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 (axillary temperature) within 48 hours of vaccination not due to another identifiable cause; - collapse or shock-like state 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.
  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: NCT00548171

Locations
Australia, New South Wales
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Booy R et al. (2011) A decennial booster dose of a reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix™) is immunogenic and well tolerated in adults. Vaccine. 29:45-50.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00548171     History of Changes
Other Study ID Numbers: 110804
Study First Received: October 22, 2007
Last Updated: March 27, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on September 30, 2014