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Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01267058
First received: December 23, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in Australia.


Condition Intervention Phase
Diphtheria
Pertussis
Tetanus
 Biological: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine
Biological: GSK Biologicals' acellular pertussis vaccine
Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Single-blind, Clinical Study of the Immunogenicity and Reactogenicity of SB Biologicals' dTpa, pa Vaccines and a Td Vaccine, Given as a Booster Dose to Healthy Adults, From the Age of 18 Years Onwards

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of solicited local and general symptoms [ Time Frame: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after the first injection ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after the second injection ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms and fever [ Time Frame: Within the 15-day (Day 0 - Day 14) follow-up period after the second injection ] [ Designated as safety issue: No ]
  • Occurrence of general solicited symptoms to vaccination, other than fever [ Time Frame: Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccine administration ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse experiences to vaccination [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccine administration ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: Immediately prior to the booster vaccination ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One year after the vaccination in a subset of subjects from all the groups ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: 2, 3, 4 and 5 years after the vaccination ] [ Designated as safety issue: No ]

Enrollment: 550
Study Start Date: September 1997
Study Completion Date: February 1998
Primary Completion Date: February 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine
 Biological: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine
Intramuscular, single dose
Active Comparator: Group B
Subjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
 Biological: GSK Biologicals' acellular pertussis vaccine
Intramuscular, single dose
Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Intramuscular, single dose
Active Comparator: Group C
Subjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine
 Biological: GSK Biologicals' acellular pertussis vaccine
Intramuscular, single dose
Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Intramuscular, single dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age at the time of the vaccination
  • Written informed consent has been obtained

Exclusion Criteria:

  • Evidence of confirmed pertussis disease within the previous 5 years
  • History of diphtheria or tetanus vaccination within the past 5 years Females must not be pregnant or lactating They must either surgically sterilized or one year post-menopausal or if they are of childbearing potential, they must be abstinent or have used adequate contraceptive precautions (or one month prior to the booster vaccination, and must agree to continue such precautions for 2 months after completion of the vaccination.
  • History of diphtheria or tetanus disease
  • History of allergic disease likely to be stimulated by the vaccination
  • Major congenital defects or serious chronic illness
  • History of progressive neurological disease
  • Immunosuppressive therapy
  • Any suspected or confirmed immune disorder
  • Immunoglobulin therapy or administration of any blood products within the previous three months or during the study period
  • Acute febrile illness (>37.5°C, axillary or oral temperature) at the time of planned vaccination
  • Administration of an investigational or non registered drug or vaccine within 30 days prior to the start of the present trial
  • Simultaneous administration of a vaccine not foreseen by the study protocol, within 30 days prior to the start of the present trial

  • Any severe or serious adverse experience having occurred after previous administration of DTP vaccine i.e:

    • an immediate anaphylactic or unacceptable reaction to the investigator's opinion, to a previous dose of diphtheria tetanus pertussis whole-cell vaccine, i.e. :
    • encephalopathy
    • fever > 40.5°C (105°F), rectal temperature, occurring after vaccination with diphtheria tetanus pertussis whole-cell vaccine and not due to another identifiable cause.
    • collapse or shock-like state
    • persistent, inconsolable crying lasting > 3 hours
    • seizures with or without fever
    • systemic allergic or neurologic reactions following a previous dose of tetanus and diphtheria toxoids vaccine
  • Exclusion from long term follow-up of antibody persistence : Evidence of confirmed pertussis, diphtheria or tetanus disease or vaccination against these diseases since previous study visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267058

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT01267058     History of Changes
Other Study ID Numbers: 263855/002
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Booster vaccination

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

ClinicalTrials.gov processed this record on May 21, 2013