Diphteria, Tetanus and PertussisPhase 3NCT01262924
Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
A Phase 3 study testing GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine, GSK Biologicals' reduced-antigen-content acellular pertussis vaccine and Tedivax-Adult™/ Td-Rix™ in people with Diphteria, Tetanus and Pertussis, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diphteria, Tetanus and Pertussis
- What is being tested?
- GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine, GSK Biologicals' reduced-antigen-content acellular pertussis vaccine and Tedivax-Adult™/ Td-Rix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Oct 1997to Dec 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
- A male or female aged ≥18 years at the time of vaccination
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
- Written informed consent obtained from the subject
- If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
- For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..
Who cannot join
- Vaccination against diphtheria and/or tetanus within the previous five years
- Vaccination against pertussis since childhood
- History of diphtheria and/or tetanus
- Known history of pertussis within the previous five years
- Known exposure to diphtheria or pertussis within the previous five years
- Known history of non-response to diphtheria, tetanus or pertussis vaccine
Show all 24Show fewer
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine
- Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after
- Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period
- Any confirmed or suspected immunosuppressive or immunodeficient condition
- Pregnant or lactating female
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Hypersensitivity to any component of the vaccines
- Acute disease at the time of enrolment
- Oral temperature of ≥37.5°C (99.5°F)
- Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines
- An immediate anaphylactic reaction
- Signs of encephalopathy
- Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:
- Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause
- Collapse or shock-like state within 48 hours of vaccination
- Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination
- Convulsions with or without fever, occurring within 3 days of vaccination
About this study
Official title: A Phase III, Blinded, Randomised, Monocentre, Comparative Clinical Study of the Immunogenicity, Reactogenicity and Safety of a Single Booster Dose of SB Biologicals' Candidate dTpa and pa Vaccines and SB Biologicals' Licensed Td Vaccine in Healthy Adults Aged ≥18 Years
The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™
- Conditions
- Diphteria, Tetanus and Pertussis
- Being tested
- GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine, GSK Biologicals' reduced-antigen-content acellular pertussis vaccine, Tedivax-Adult™/ Td-Rix™
- Keywords
- Booster vaccination
- Medical subject headings
- Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccineBiological
Intramuscular, single dose
GSK Biologicals' reduced-antigen-content acellular pertussis vaccineBiological
Intramuscular, single dose
Tedivax-Adult™/ Td-Rix™Biological
Intramuscular, single dose or 2 doses (in the annex phase)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | dTPa vaccine Receives: Biological: GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine |
| Group B | Experimental | Pa vaccine Receives: Biological: GSK Biologicals' reduced-antigen-content acellular pertussis vaccine |
| Group C | Active comparator | Tedivax-Adult™/ Td-Rix™ Receives: Biological: Tedivax-Adult™/ Td-Rix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
Measured: One month after the booster dose (Month 1)
Secondary outcomes (11)
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
Measured: One month after the booster dose (Month 1)
Occurrence of solicited local adverse experiences
Measured: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of solicited general adverse experiences
Measured: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of unsolicited symptoms
Measured: Within the 31-day (Day 0 -30) follow-up period after vaccination
Occurrence of any serious adverse experiences
Measured: Within the 31-day (Day 0 -30) follow-up period after vaccination
Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
Measured: At pre-vaccination (Day 0) and Month 1 post-vaccination
Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Measured: One month after the second and third booster dose (Month 12)
Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Measured: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Measured: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Measured: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Measured: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startOct 1997
- Primary completionDec 1998
- Study completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diphteria, Tetanus and PertussisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262924
- Sponsor's protocol ID
- 263855/003
- Status last verified
- Dec 2010
- First submitted
- 16 Dec 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Blinded, Randomised, Monocentre, Comparative Clinical Study of the Immunogenicity, Reactogenicity and Safety of a Single Booster Dose of SB Biologicals' Candidate dTpa and pa Vaccines and SB Biologicals' Licensed Td Vaccine in Healthy Adults Aged ≥18 Years
- ClinicalTrials.gov ID
- NCT01262924
- Acronym / sponsor ID
- 263855/003
- Conditions
- Diphteria, Tetanus and Pertussis
- Keywords
- Booster vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 1997
- Primary completion
- Dec 1998 (actual)
- Study completion
- Dec 1998 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccinedTPa vaccine |
| Group B | Experimental | Biological: GSK Biologicals' reduced-antigen-content acellular pertussis vaccinePa vaccine |
| Group C | Active comparator | Biological: Tedivax-Adult™/ Td-Rix™Tedivax-Adult™/ Td-Rix™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A male or female aged ≥18 years at the time of vaccination
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
- Written informed consent obtained from the subject
- If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
- For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..
Key exclusion criteria (24 listed)
- Vaccination against diphtheria and/or tetanus within the previous five years
- Vaccination against pertussis since childhood
- History of diphtheria and/or tetanus
- Known history of pertussis within the previous five years
- Known exposure to diphtheria or pertussis within the previous five years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccineIntramuscular, single dose | Biological | Group A |
| GSK Biologicals' reduced-antigen-content acellular pertussis vaccineIntramuscular, single dose | Biological | Group B |
| Tedivax-Adult™/ Td-Rix™Intramuscular, single dose or 2 doses (in the annex phase) | Biological | Group C |
Primary outcome
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
Time frame: One month after the booster dose (Month 1)
11 secondary outcomes
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
Time frame: One month after the booster dose (Month 1)
Occurrence of solicited local adverse experiences
Time frame: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of solicited general adverse experiences
Time frame: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of unsolicited symptoms
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination
Occurrence of any serious adverse experiences
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination
Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
Time frame: At pre-vaccination (Day 0) and Month 1 post-vaccination
Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: One month after the second and third booster dose (Month 12)
Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
- Results publication: PubMed 14670310Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine, GSK Biologicals' reduced-antigen-content acellular pertussis vaccine and Tedivax-Adult™/ Td-Rix™ in people with Diphteria, Tetanus 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 5 inclusion and 24 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 17 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?
Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™) (time frame: One month after the booster dose (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 NCT01262924, which also lists 1 linked publication.
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 17 Dec 2010.