Acellular PertussisPhase 4NCT01294605
Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
A Phase 4 study testing Boostrix™ (dTpa), GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM) and Ditanrix™ Adult, TedivaxTM (Td) in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 13 sites in 3 countries.
Trial summary
This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acellular Pertussis, Tetanus, Diphtheria
- What is being tested?
- Boostrix™ (dTpa), GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM) and Ditanrix™ Adult, TedivaxTM (Td)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Apr 2003to Sep 2004
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
- A male or female adult >= 40 years of age
- Written informed consent to be obtained from the subject prior to study entry
- No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- subject should not be pregnant or plan to become pregnant.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
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- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions
- Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Any confirmed or suspected immunosuppressive or immunodeficient condition
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Spain8 sites
GSK Investigational Site
Alzira, 46600
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 8025
GSK Investigational Site
Centelles
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Mollet del Vallès, 08100
GSK Investigational Site
Vic, 28500
Belgium3 sites
GSK Investigational Site
Bruges, 8000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Wilrijk, 2610
Netherlands2 sites
GSK Investigational Site
Rotterdam, 3015 GE
GSK Investigational Site
Utrecht, 3584 CJ
About this study
Official title: Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule
This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Being tested
- Boostrix™ (dTpa), GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM), Ditanrix™ Adult, TedivaxTM (Td)
- Keywords
- DTPa, Td, IPV
- Medical subject headings
- Tetanus, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix™ (dTpa)Biological
Intramuscular, 3 doses
GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)Biological
Intramuscular, single dose
Ditanrix™ Adult, TedivaxTM (Td)Biological
Intramuscular, 2 doses
Ditanrix™ Adult, TedivaxTM (Td)Biological
Intramuscular, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Boostrix™ (dTpa) |
| Group B | Experimental | Not described Receives: Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM); Biological: Ditanrix™ Adult, TedivaxTM (Td) |
| Group C | Active comparator | Not described Receives: Biological: Ditanrix™ Adult, TedivaxTM (Td) |
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
Measured: One month after the third dose (Month 7)
Secondary outcomes (6)
Immunogenicity with respect to components of the study vaccines
Measured: One month after each dose (Months 1, 2 and 7)
Occurrence of solicited local and general symptoms
Measured: Within 15 days (day 0 -14) after each vaccine dose.
Occurrence of unsolicited symptoms
Measured: Within 31 days (day 0-30) after each vaccine dose.
Occurrence of serious adverse events
Measured: Until 31 days (day 0-30) after the last vaccine dose.
Occurrence of large local swelling reported
Measured: Within 15 days (day 0-14) after each vaccine dose
Use of concomitant medication taken
Measured: Within 31 days (day 0-30) after each vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startApr 2003
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acellular 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294605
- Sponsor's protocol ID
- 263855/034
- Status last verified
- Sep 2016
- First submitted
- 10 Feb 2011
- Last updated
- 15 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
Theeten H, Rumke H, Hoppener FJ, Vilatimo R, Narejos S, Van Damme P, Hoet B. Primary vaccination of adults with reduced antigen-content diphtheria-tetanus-acellular pertussis or dTpa-inactivated poliovirus vaccines compared to diphtheria-tetanus-toxoid vaccines. Curr Med Res Opin. 2007 Nov;23(11):2729-39. doi: 10.1185/03007x233034.
PubMed 17897485Van 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 21718738Van Damme P et al. Primary vaccination of adults with reduced antigen content diphtheria-tetanus-acellular pertussis (dTpa) vaccines. Abstract presented at the 27th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Brussels, Belgium. 09-13 June 2009.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule
- ClinicalTrials.gov ID
- NCT01294605
- Acronym / sponsor ID
- 263855/034
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Keywords
- DTPa, Td, IPV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 11 Feb 2011 (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.
This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Boostrix™ (dTpa) |
| Group B | Experimental | Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM), Biological: Ditanrix™ Adult, TedivaxTM (Td) |
| Group C | Active comparator | Biological: Ditanrix™ Adult, TedivaxTM (Td) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study
- A male or female adult >= 40 years of age
- Written informed consent to be obtained from the subject prior to study entry
- No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (11 listed)
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures
- Acute disease at the time of enrolment.
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 |
|---|---|---|
| Boostrix™ (dTpa)Intramuscular, 3 doses | Biological | Group A |
| GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)Intramuscular, single dose | Biological | Group B |
| Ditanrix™ Adult, TedivaxTM (Td)Intramuscular, 2 doses | Biological | Group B |
| Ditanrix™ Adult, TedivaxTM (Td)Intramuscular, 3 doses | Biological | Group C |
Primary outcome
Immunogenicity with respect to components of the study vaccines
Time frame: One month after the third dose (Month 7)
6 secondary outcomes
Immunogenicity with respect to components of the study vaccines
Time frame: One month after each dose (Months 1, 2 and 7)
Occurrence of solicited local and general symptoms
Time frame: Within 15 days (day 0 -14) after each vaccine dose.
Occurrence of unsolicited symptoms
Time frame: Within 31 days (day 0-30) after each vaccine dose.
Occurrence of serious adverse events
Time frame: Until 31 days (day 0-30) after the last vaccine dose.
Occurrence of large local swelling reported
Time frame: Within 15 days (day 0-14) after each vaccine dose
Use of concomitant medication taken
Time frame: Within 31 days (day 0-30) after each 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 15 Sep 2016.
- Background: PubMed 17897485Theeten H, Rumke H, Hoppener FJ, Vilatimo R, Narejos S, Van Damme P, Hoet B. Primary vaccination of adults with reduced antigen-content diphtheria-tetanus-acellular pertussis or dTpa-inactivated poliovirus vaccines compared to diphtheria-tetanus-toxoid vaccines. Curr Med Res Opin. 2007 Nov;23(11):2729-39. doi: 10.1185/03007x233034.
- Background: PubMed 21718738Van 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.
- BackgroundVan Damme P et al. Primary vaccination of adults with reduced antigen content diphtheria-tetanus-acellular pertussis (dTpa) vaccines. Abstract presented at the 27th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Brussels, Belgium. 09-13 June 2009.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix™ (dTpa), GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM) and Ditanrix™ Adult, TedivaxTM (Td) in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 13 sites in 3 countries.
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 6 inclusion and 11 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 the third dose (Month 7)). 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 NCT01294605, which also lists 3 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 15 Sep 2016.