Last updated: 11/04/2018 01:31:29
Booster study of combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
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:
Immunogenicity with respect to components of the study vaccines
Timeframe: One month after the first injection
Immunogenicity with respect to components of the study vaccines
Timeframe: One month after the second injection
Occurrence of solicited local symptoms and fever
Timeframe: 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
Timeframe: Within the 15-day (Day 0 – Day 14) follow-up period after each vaccine administration
Occurrence of unsolicited symptoms
Timeframe: Within 31 days (Day 0 – Day 30) after each vaccine administration
Occurrence of serious adverse experiences to vaccination
Timeframe: Within 31 days (Day 0 – Day 30) after each vaccine administration
Immunogenicity with respect to components of the study vaccines
Timeframe: Immediately prior to the booster vaccination
Immunogenicity with respect to components of the study vaccines
Timeframe: One year after the vaccination in a subset of subjects from all the groups
Immunogenicity with respect to components of the study vaccines
Timeframe: 2, 3, 4 and 5 years after the vaccination
Interventions:
Enrollment:
550
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
McIntyre PB et al. (2009) Booster vaccination of adults with reduced-antigen-content diphtheria, tetanus and pertussis vaccine: immunogenicity 5 years post-vaccination. Vaccine. 27(7):1062-1066.
Cheuvart B et al. (2004) Anti-diphtheria antibody seroprotection rates are similar 10 years after vaccination with dTpa or DTPa using a mathematical model. Vaccine. 23(3):336-42.
Van Damme P et al. (2004) Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults. Vaccine. 22: 305-308.
Turnbull FM et al. (2001) A randomized trial of two acellular pertussis vaccines (dTpa and pa) and a licensed diphtheria-tetanus vaccine (Td) in adults. Vaccine. 19(6): 628-636.
Burgess M et al. Booster vaccination of healthy adults with reduced-antigen-content diphtheria, tetanus and pertussis vaccines: immunogenicity five years post-vaccination. Abstract presented at the 10th ACVR, Baltimore, MD, 30 April - 2 May 2007.
Cheuvart B et al. (2004) Anti-diphtheria antibody seroprotection rates are similar 10 years after vaccination with dTpa or DTPa using a mathematical model. Vaccine. 23(3):336-342.
McIntyre PB et al. (2004) High levels of antibody in adults three years after vaccination with a reduced antigen content diphtheria-tetanus-acellular pertussis vaccine. Vaccine. 23(3):380-385.
Turnbull FM et al. (2000) A randomized trial of two acellular pertussis vaccines (dTpa and pa) and a licensed diphtheria-tetanus vaccine (Td) in adults. Vaccine. 19(6): 628-636.
Van Damme P et al. (2011) Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix(®)) in adults 55 years of age and over: A sub-analysis of four trials. Vaccine. 29(35):5932-5939.
Medical condition
Diphtheria, Pertussis, Tetanus
Product
Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
Collaborators
Not applicable
Study date(s)
September 1997 to February 1998
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- At least 18 years of age at the time of the vaccination
- Written informed consent has been obtained
- Evidence of confirmed pertussis disease within the previous 5 years
- History of diphtheria or tetanus vaccination within the past 5 years
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent has been obtained
At least 18 years of age at the time of the vaccination
Exclusion criteria:
- 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
- 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
Evidence of confirmed pertussis disease within the previous 5 years
systemic allergic or neurologic reactions following a previous dose of tetanus and diphtheria toxoids vaccine
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1998-28-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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