Clinical trial NCT01267058: Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Pertussis
Tetanus
Keywords: Booster vaccination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Occurrence of solicited local and general symptoms
timeFrame: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection
Secondary outcomes:
measure: Immunogenicity with respect to components of the study vaccines
timeFrame: One month after the first injection
measure: Immunogenicity with respect to components of the study vaccines
timeFrame: One month after the second injection
measure: Occurrence of solicited local symptoms and fever
timeFrame: Within the 15-day (Day 0 - Day 14) follow-up period after the second injection
measure: Occurrence of general solicited symptoms to vaccination, other than fever
timeFrame: Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration
measure: Occurrence of unsolicited symptoms
timeFrame: Within 31 days (Day 0 - Day 30) after each vaccine administration
measure: Occurrence of serious adverse experiences to vaccination
timeFrame: Within 31 days (Day 0 - Day 30) after each vaccine administration
measure: Immunogenicity with respect to components of the study vaccines
timeFrame: Immediately prior to the booster vaccination
measure: Immunogenicity with respect to components of the study vaccines
timeFrame: One year after the vaccination in a subset of subjects from all the groups
measure: Immunogenicity with respect to components of the study vaccines
timeFrame: 2, 3, 4 and 5 years after the vaccination
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.