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

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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria
• Intervention / Treatment: Biological: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine; Biological: GSK Biologicals' acellular pertussis vaccine; Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of solicited local and general symptoms	Within the 15-day (Day 0 - Day 14) follow-up period after the first injection

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity with respect to components of the study vaccines	One month after the first injection
Immunogenicity with respect to components of the study vaccines	One month after the second injection
Occurrence of solicited local symptoms and fever	Within the 15-day (Day 0 - Day 14) follow-up period after the second injection
Occurrence of general solicited symptoms to vaccination, other than fever	Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration
Occurrence of unsolicited symptoms	Within 31 days (Day 0 - Day 30) after each vaccine administration
Occurrence of serious adverse experiences to vaccination	Within 31 days (Day 0 - Day 30) after each vaccine administration
Immunogenicity with respect to components of the study vaccines	Immediately prior to the booster vaccination
Immunogenicity with respect to components of the study vaccines	One year after the vaccination in a subset of subjects from all the groups
Immunogenicity with respect to components of the study vaccines	2, 3, 4 and 5 years after the vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Cheuvart B, Burgess M, Zepp F, Mertsola J, Wolter J, Schuerman L. Anti-diphtheria antibody seroprotection rates are similar 10 years after vaccination with dTpa or DTPa using a mathematical model. Vaccine. 2004 Dec 2;23(3):336-42. doi: 10.1016/j.vaccine.2004.06.012.
• Van Damme P, Burgess M. Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults. Vaccine. 2004 Jan 2;22(3-4):305-8. doi: 10.1016/j.vaccine.2003.08.012.
• Turnbull FM, Heath TC, Jalaludin BB, Burgess MA, Ramalho AC. A randomized trial of two acellular pertussis vaccines (dTpa and pa) and a licensed diphtheria-tetanus vaccine (Td) in adults. Vaccine. 2000 Nov 8;19(6):628-36. doi: 10.1016/s0264-410x(00)00252-8.
• McIntyre PB, Burgess MA, Egan A, Schuerman L, Hoet B. Booster vaccination of adults with reduced-antigen-content diphtheria, Tetanus and pertussis vaccine: immunogenicity 5 years post-vaccination. Vaccine. 2009 Feb 11;27(7):1062-6. doi: 10.1016/j.vaccine.2008.11.102. Epub 2008 Dec 16.

Study record dates

Study Major Dates

• Study Start: September 1, 1997
• Primary Completion (ACTUAL): February 1, 1998
• Study Completion (ACTUAL): February 1, 1998

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (ESTIMATE): December 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 24, 2010
• Last Update Submitted That Met QC Criteria: December 23, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Booster vaccination
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 263855/002