Acellular PertussisPhase 4NCT00610168
Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.
A Phase 4 study testing Boostrix TM in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 1 site in Finland.
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 prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Acellular Pertussis, Tetanus, Diphtheria
- What is being tested?
- Boostrix TM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2008to 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 20 to 24 years
- All sexes
- Healthy volunteers accepted
- 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 263855/004.
- A male or female subject, recruited 10 years after booster vaccination in study 263855/004.
- 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 use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
- Written informed consent obtained from the subject.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster 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 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 tetanus, diphtheria or pertussis since the last dose received in study 263855/004.
- History of documented diphtheria, tetanus, or pertussis diseases.
Show all 19Show 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 within 48 hours of vaccination not due to another identifiable cause,
- collapse or shock-like state (hypotonic-hyporesponsiveness episode) 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 within 2 months after completion of the vaccination series.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of GSK Biologicals' dTpa Booster Vaccine in Young Adults 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 prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
Read the detailed description
This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Being tested
- Boostrix TM
- Keywords
- dTpa vaccine, pertussis, Tdap, Boostrix, booster, tetanus, diphtheria
- Medical subject headings
- Tetanus, Diphtheria, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boostrix TMBiological
Also called dTpa vaccine
Single booster dose of vaccine
| Study group | Role | What they receive |
|---|---|---|
| BOOSTRIX I GROUP | Experimental | Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. Receives: Biological: Boostrix TM |
| BOOSTRIX II GROUP | Experimental | Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. Receives: Biological: Boostrix TM |
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 Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Measured: At Month 0
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Measured: At Month 1
Secondary outcomes (8)
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Concentrations are presented as international units per millilitre (IU/mL).
Measured: At Month 0 (PRE) and Month 1 (POST)
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)
Measured: At Month 0 (PRE) and Month 1 (POST)
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Measured: At Month 0 (PRE) and Month 1 (POST)
Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (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 prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.
Measured: At Month 1
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.
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 and gastrointestinal symptoms. 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.
Measured: During the 4-day (Day 0-3) follow-up period after booster vaccination
Number of Subjects With 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.
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.
Measured: For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study start1 Jan 2008
- 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 (7)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
- 82 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
- NCT00610168
- Sponsor's protocol ID
- 110806
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2008
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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
He Q et al. Immunity to pertussis 10 years after acellular booster vaccine in adolescence and response to a second dTpa booster in young adults. Abstract presented at the 19th annual european congress of clinical microbiology and infectious diseases, Helsinki, Finland, 16-19 May 2009.
Mertsola J, Van Der Meeren O, He Q, Linko-Parvinen A, Ramakrishnan G, Mannermaa L, Soila M, Pulkkinen M, Jacquet JM. Decennial administration of a reduced antigen content diphtheria and tetanus toxoids and acellular pertussis vaccine in young adults. Clin Infect Dis. 2010 Sep 15;51(6):656-62. doi: 10.1086/655825.
PubMed 20704493Mertsola J et al. Decennial administration of reduced-antigen dTpa vaccine in young adults - incidence of solicited local symptoms classified by pre-vaccination antibody concentrations. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Mertsola J et al. The immunogenicity and safety of repeated administration of dTpa booster in adolescents and young adults. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID-6th World Congress. 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-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of GSK Biologicals' dTpa Booster Vaccine in Young Adults 10 Years After Previous dTpa Boosting.
- ClinicalTrials.gov ID
- NCT00610168
- Acronym / sponsor ID
- 110806
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Keywords
- dTpa vaccine, pertussis, Tdap, Boostrix, booster, tetanus, diphtheria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2008
- Primary completion
- 30 Apr 2008 (actual)
- Study completion
- 30 Apr 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 30 Mar 2017
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 prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
Detailed description
This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
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 TMSubjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. |
| BOOSTRIX II GROUP | Experimental | Biological: Boostrix TMSubjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 263855/004.
- A male or female subject, recruited 10 years after booster vaccination in study 263855/004.
- 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 use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
Key exclusion criteria (19 listed)
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster 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 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 tetanus, diphtheria or pertussis since the last dose received in study 263855/004.
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 TMAlso: dTpa vaccineSingle booster dose of vaccine | Biological | BOOSTRIX I GROUP, BOOSTRIX II GROUP |
Primary outcome
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
Time frame: At Month 0
The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
Time frame: At Month 1
The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
8 secondary outcomes
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Time frame: At Month 0 (PRE) and Month 1 (POST)
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Time frame: At Month 0 (PRE) and Month 1 (POST)
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Time frame: At Month 0 (PRE) and Month 1 (POST)
Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Time frame: At Month 1
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 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: For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundHe Q et al. Immunity to pertussis 10 years after acellular booster vaccine in adolescence and response to a second dTpa booster in young adults. Abstract presented at the 19th annual european congress of clinical microbiology and infectious diseases, Helsinki, Finland, 16-19 May 2009.
- Background: PubMed 20704493Mertsola J, Van Der Meeren O, He Q, Linko-Parvinen A, Ramakrishnan G, Mannermaa L, Soila M, Pulkkinen M, Jacquet JM. Decennial administration of a reduced antigen content diphtheria and tetanus toxoids and acellular pertussis vaccine in young adults. Clin Infect Dis. 2010 Sep 15;51(6):656-62. doi: 10.1086/655825.
- BackgroundMertsola J et al. Decennial administration of reduced-antigen dTpa vaccine in young adults - incidence of solicited local symptoms classified by pre-vaccination antibody concentrations. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
- BackgroundMertsola J et al. The immunogenicity and safety of repeated administration of dTpa booster in adolescents and young adults. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
- BackgroundMertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID-6th World Congress. 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-6th World Congress. 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. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Acellular Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Not yet recruitingObservational study
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
Diphtheria, Tetanus
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 TM in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 1 site in Finland.
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 19 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 6 Jun 2018. 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 Finland. 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 30 Mar 2017). 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 Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs (time frame: At Month 0). The study lists 2 primary outcomes in all. 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 NCT00610168, which also lists 7 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 6 Jun 2018.