Acellular PertussisPhase 4NCT00548171
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
A Phase 4 study testing Boostrix™ in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study (NCT01267058). Read more about this study
- Who is it for?
- Ages 28 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acellular Pertussis, Tetanus, Diphtheria
- What is being tested?
- Boostrix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Nov 2007to 30 Apr 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 28 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/002 .
- A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination in study 263855/002.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential 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 booster vaccination.
- Written informed consent obtained from the subject.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Previous booster vaccination against diphtheria, tetanus or pertussis since the last dose received in study 263855/002
- History of diphtheria, tetanus, or pertussis diseases.
Show all 14Show fewer
- Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
- Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
- Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :- hypersensitivity reaction to any component of the vaccine; - encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine; - fever ≥ 40 °C (axillary temperature) within 48 hours of vaccination not due to another identifiable cause; - collapse or shock-like state within 48 hours of vaccination; - convulsions with or without fever, occurring within 3 days of vaccination.
- Acute disease at the time of enrolment.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 10 Years After Previous dTpa Boosting.
The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study (NCT01267058). Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
No new recruitment will be performed in this booster phase (see inclusion criteria).
- Being tested
- Boostrix™
- 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™Biological
Intramuscular injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Boostrix I Group | Experimental | Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Boostrix™ |
| Boostrix II Group | Active comparator | Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm. Receives: Biological: Boostrix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL)
Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).
The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster.
Measured: One month after the booster vaccination [PI(M1)]
Secondary outcomes (19)
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL.
Measured: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and ≥ 1 IU/mL.
This endpoint presents results for subjects included in the ATP cohort for antibody persistence.
Measured: Prior (PRE) to booster vaccination
Anti-DT and Anti-TT Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: Prior to the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Measured: Prior the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
Measured: Prior the booster vaccination
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.
Measured: Prior the booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL)
Measured: Prior the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA.
Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Measured: Prior to the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test.
Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
Measured: Prior to the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA.
Measured: One month after the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥ 0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies.
Measured: One month after the booster vaccination
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination.
Measured: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Measured: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL).
Measured: One month after the booster vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Measured: During the 4-day (Day 0-3) follow-up period after booster vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Measured: During the 4-day (Day 0-3) follow-up period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Measured: During the 31-day (Day 0-30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
Measured: Following the booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study start5 Nov 2007
- Primary completion30 Apr 2008
- Study completion30 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 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
- NCT00548171
- Sponsor's protocol ID
- 110804
- Status last verified
- Dec 2019
- First submitted
- 22 Oct 2007
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Booy R, Van der Meeren O, Ng SP, Celzo F, Ramakrishnan G, Jacquet JM. A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix) is immunogenic and well tolerated in adults. Vaccine. 2010 Dec 10;29(1):45-50. doi: 10.1016/j.vaccine.2010.10.025. Epub 2010 Oct 23.
PubMed 20974302Booy R et al. The decennial administration of a reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (dTpa; BoostrixTM) in adults. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 10 Years After Previous dTpa Boosting.
- ClinicalTrials.gov ID
- NCT00548171
- Acronym / sponsor ID
- 110804
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2007 (actual)
- Primary completion
- 30 Apr 2008 (actual)
- Study completion
- 30 Apr 2008 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Posted 15 Jan 2019
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 efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study (NCT01267058). Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
No new recruitment will be performed in this booster phase (see inclusion criteria).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boostrix I Group | Experimental | Biological: Boostrix™Subjects who had received the Boostrix™ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. |
| Boostrix II Group | Active comparator | Biological: Boostrix™Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrix™ vaccine intramuscularly in the deltoid region of the non-dominant arm. |
Who may qualify
- Ages
- 28 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/002 .
- A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination in study 263855/002.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential 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 booster vaccination.
Key exclusion criteria (14 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Previous booster vaccination against diphtheria, tetanus or pertussis since the last dose received in study 263855/002
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™Intramuscular injection, 1 dose | Biological | Boostrix I Group, Boostrix II Group |
Primary outcome
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL)
Time frame: One month after the booster vaccination [PI(M1)]
Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster.
19 secondary outcomes
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values
Time frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Time frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values
Time frame: Prior (PRE) to booster vaccination
Anti-DT and Anti-TT Antibody Concentrations
Time frame: Prior to the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Time frame: Prior the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Time frame: Prior the booster vaccination
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Time frame: Prior the booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Prior the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA.
Time frame: Prior to the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test.
Time frame: Prior to the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - ELISA
Time frame: One month after the booster vaccination
Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test
Time frame: One month after the booster vaccination
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Time frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Prior to (PRE) and one month after [PI(M1)] the booster vaccination
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Time frame: One month after the booster vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Day 0-3) follow-up period after booster vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Day 0-3) follow-up period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0-30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Following the booster vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20974302Booy R, Van der Meeren O, Ng SP, Celzo F, Ramakrishnan G, Jacquet JM. A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix) is immunogenic and well tolerated in adults. Vaccine. 2010 Dec 10;29(1):45-50. doi: 10.1016/j.vaccine.2010.10.025. Epub 2010 Oct 23.
- BackgroundBooy R et al. The decennial administration of a reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (dTpa; BoostrixTM) in adults. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009.
- BackgroundMertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009.
- BackgroundMertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.
- BackgroundMertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 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. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Boostrix™ in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 1 site in Australia.
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 14 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL) (time frame: One month after the booster vaccination [PI(M1)]). 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 NCT00548171, which also lists 5 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 13 Jan 2020.