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AzTrials

TetanusPhase 3NCT01277705

Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis®

A Phase 3 study testing GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine, Boostrix™ and GSK Biologicals' IPV vaccine in people with Tetanus and Diphtheria, run by GlaxoSmithKline.

Completed

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

Official record
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Trial summary

This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Tetanus, Diphtheria, Acellular Pertussis
What is being tested?
GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine, Boostrix™ and GSK Biologicals' IPV vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
806 participants
Where
No sites listed yet
Study dates
Jan 2002to Apr 2002
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • A male or female subjects aged 15 years and over (Germany), or 18 years and over (France) at the time of the vaccination.
  • Written informed consent obtained.
  • Free of obvious health problems Having received primary vaccination with diphtheria and tetanus vaccines to the best of his/her knowledge.
  • Female subjects must not be pregnant or lactating.

Who cannot join

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
  • History of previous or intercurrent diphtheria or tetanus, pertussis or polio disease in the last 10 years.
  • French subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
  • German subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 5 years, except those subjects participating in the tetanus antibody kinetic subgroup.
  • German subjects participating in the tetanus antibody kinetic subgroup: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
  • Administration or planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the study vaccine dose and ending 30 days after study vaccination.
Show all 22Show fewer
  • Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs within six months or 5 half-lives (whichever is the longer) of vaccination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition,
  • History of seizures or progressive neurological disease.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • The following adverse experiences associated with diphtheria-tetanus-pertussis vaccination constitute absolute contraindications to further administration of diphtheria-tetanus-pertussis vaccine; if any of these adverse experiences occurred following previous vaccinations, the subject should not be included:
  • Absolute contraindications:
  • Hypersensitivity reaction due to the vaccine.
  • Encephalopathy
  • Precautions:
  • Fever >= 40.0°C within 48 hours of vaccination not due to another identifiable cause.
  • Collapse or shock-like state within 48 hours of vaccination.
  • Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination.
  • Seizures with or without fever occurring within 3 days of vaccination.

About this study

Official title: Assess Immunogenicity, Reactogenicity of GSK Biologicals'-dTpa-IPV Vaccine Versus dTpa & IPV Vaccines Administered Separately & Compared With Aventis Pasteur MSD's Td-IPV Vaccine When Administered to Healthy Adolescents & Adults

This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®

Being tested
GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine, Boostrix™, GSK Biologicals' IPV vaccine, Revaxis®
Keywords
Booster vaccination
Medical subject headings
Tetanus, Diphtheria

What participants receive

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

  • GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccineBiological

    Intramuscular, single

  • Boostrix™Biological

    Intramuscular, single dose

  • GSK Biologicals' IPV vaccineBiological

    Intramuscular, single dose

  • Revaxis®Biological

    Intramuscular, single dose

Study groups in NCT01277705
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
Group BExperimentalNot described
Receives: Biological: Boostrix™; Biological: GSK Biologicals' IPV vaccine
Group CActive comparatorNot described
Receives: Biological: Revaxis®

What is being measured

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

  1. Immunogenicity with respect to components of the study vaccines

    Measured: One month after vaccination (Month 1)

Secondary outcomes (5)

  1. Immunogenicity with respect to components of the study vaccines

    Measured: One month after vaccination (Month 1)

  2. Immunogenicity with respect to some component of the study vaccines

    Measured: At Day 10 after vaccination

  3. Occurrence of solicited local and general symptoms

    Measured: within 15 (Day 0-14) days after vaccination

  4. Occurrence of unsolicited symptoms

    Measured: within 30 days (Day 0-29) after vaccination

  5. Occurrence of serious adverse events

    Measured: Throughout the entire study (from Day 0 to Day 30)

Timeline

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

  1. First posted17 Jan 2011 (estimated)
  2. Study startJan 2002
  3. Primary completionApr 2002
  4. Study completionApr 2002

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
None (open label)
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01277705
Sponsor's protocol ID
711866/003
Status last verified
Sep 2016
First submitted
13 Jan 2011
Last updated
7 Sep 2016
Results posted
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Van Damme P, McIntyre P, Grimprel E, Kuriyakose S, Jacquet JM, Hardt K, Messier M, Van Der Meeren O. Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix((R))) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine. 2011 Aug 11;29(35):5932-9. doi: 10.1016/j.vaccine.2011.06.049. Epub 2011 Jun 28.

    PubMed 21718738

  • Grimprel E, von Sonnenburg F, Sanger R, Abitbol V, Wolter JM, Schuerman LM. Combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and polio vaccine (dTpa-IPV) for booster vaccination of adults. Vaccine. 2005 May 25;23(28):3657-67. doi: 10.1016/j.vaccine.2005.02.013.

    PubMed 15882526

  • Wolter J et al. Boostrix polio: A new combined vaccine to fulfill emerging needs for pertussis vaccination of older age-groups. Abstract presented at the ESPID, Tampere, Finland, 26-28 May 2004.

  • Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.

    PubMed 25882172

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine, Boostrix™ and GSK Biologicals' IPV vaccine in people with Tetanus and Diphtheria, 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 4 inclusion and 22 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 7 Sep 2016. 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?

Immunogenicity with respect to components of the study vaccines (time frame: One month after vaccination (Month 1)). 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 NCT01277705, 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 7 Sep 2016.

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