AzTrials
AzTrials

DiphtheriaPhase 3NCT01267058

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

A Phase 3 study testing GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine, GSK Biologicals' acellular pertussis vaccine and Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine in people with Diphtheria and Pertussis, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diphtheria, Pertussis, Tetanus
What is being tested?
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine, GSK Biologicals' acellular pertussis vaccine and Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
No sites listed yet
Study dates
Sep 1997to Feb 1998
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

About this study

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

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.

Being tested
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine, GSK Biologicals' acellular pertussis vaccine, Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Keywords
Booster vaccination
Medical subject headings
Diphtheria, Whooping Cough, Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccineBiological

    Intramuscular, single dose

  • GSK Biologicals' acellular pertussis vaccineBiological

    Intramuscular, single dose

  • Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccineBiological

    Intramuscular, single dose

Study groups in NCT01267058
Study groupRoleWhat they receive
Group AExperimentalSubjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine
Receives: Biological: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine
Group BActive comparatorSubjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
Receives: Biological: GSK Biologicals' acellular pertussis vaccine; Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Group CActive comparatorSubjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine
Receives: Biological: GSK Biologicals' acellular pertussis vaccine; Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of solicited local and general symptoms

    Measured: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection

Secondary outcomes (9)

  1. Immunogenicity with respect to components of the study vaccines

    Measured: One month after the first injection

  2. Immunogenicity with respect to components of the study vaccines

    Measured: One month after the second injection

  3. Occurrence of solicited local symptoms and fever

    Measured: Within the 15-day (Day 0 - Day 14) follow-up period after the second injection

  4. Occurrence of general solicited symptoms to vaccination, other than fever

    Measured: Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration

  5. Occurrence of unsolicited symptoms

    Measured: Within 31 days (Day 0 - Day 30) after each vaccine administration

  6. Occurrence of serious adverse experiences to vaccination

    Measured: Within 31 days (Day 0 - Day 30) after each vaccine administration

  7. Immunogenicity with respect to components of the study vaccines

    Measured: Immediately prior to the booster vaccination

  8. Immunogenicity with respect to components of the study vaccines

    Measured: One year after the vaccination in a subset of subjects from all the groups

  9. Immunogenicity with respect to components of the study vaccines

    Measured: 2, 3, 4 and 5 years after the vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2010 (estimated)
  2. Study startSep 1997
  3. Primary completionFeb 1998
  4. Study completionFeb 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267058
Sponsor's protocol ID
263855/002
Status last verified
Dec 2010
First submitted
23 Dec 2010
Last updated
24 Dec 2010
Results posted
No

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.

    PubMed 15530678

  • 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.

    PubMed 14670310

  • 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.

    PubMed 11090714

  • 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.

    PubMed 19095033

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine, GSK Biologicals' acellular pertussis vaccine and Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine in people with Diphtheria and Pertussis, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of solicited local and general symptoms (time frame: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267058, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in