Acellular PertussisPhase 4NCT01147900

Evaluation of Boostrix™10 Years After Previous Booster Vaccination

A Phase 4 study testing Boostrix™ and Boostrix™-US formulation in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 3 sites in Belgium.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 28 yearsHealthy volunteers can take part
Conditions the study is for: Acellular Pertussis, Tetanus, Diphtheria
What is being tested?: Boostrix™ and Boostrix™-US formulation
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 3 sitesBelgium
Study dates: 15 Jun 2010to 8 May 2012
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 18 to 28 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.
Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029.
Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
Healthy subjects as established by medical history and clinical examination.
Female subjects of non-childbearing potential may receive the booster vaccine.
Female subjects of childbearing potential may receive the booster vaccine, if the subject:

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practices/has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
agrees to continue adequate contraception during the entire booster epoch.

Who cannot join

Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.
History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
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 :

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hypersensitivity reaction to any component of the vaccine,
encephalopathy of unknown aetiology occurring within seven 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 three days of vaccination.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Additional exclusion criteria to be checked for subjects before the booster vaccination administration:
Use of any investigational or non-registered product other than the study vaccine(s) 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.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

About this study

Official title: Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate study (see reference).

Read the detailed description

All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.

Conditions: Acellular Pertussis, Tetanus, Diphtheria
Being tested: Boostrix™, Boostrix™-US formulation
Keywords: Immune persistence, Boostrix, dTpa booster study
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, single dose
Boostrix™-US formulationBiological
Intramuscular, single dose

Study groups in NCT01147900
Study group	Role	What they receive
Boostrix-REF Group	Experimental	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. Receives: Biological: Boostrix™
Boostrix-US Group	Experimental	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. Receives: Biological: Boostrix™-US formulation
Boostrix-INV Group	Experimental	Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle 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 Seroprotected Subjects Against Diphtheria and Tetanus
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Measured: At Year 8.5
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Measured: At Year 8.5
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Measured: At Year 10
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Measured: At Year 10
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: At Year 8.5
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
Measured: At Year 8.5
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: At Year 10
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Measured: At Year 10
Number of Seroprotected Subjects Against Diphtheria and Tetanus
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Measured: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations for Anti-D and Anti-T Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Measured: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Measured: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Measured: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination.
A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.
Measured: At 1 month post Year 10 booster vaccination

Secondary outcomes (5)

Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.
Measured: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.
Measured: During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..
Measured: At Year 8.5
Number of Subjects With Any 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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Year 8.5 up to study end (one month post Year 10 booster vaccination)

Timeline

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

15 Jun 20108 May 2012

First posted22 Jun 2010 (estimated)
Study start15 Jun 2010
Primary completion8 May 2012
Study completion8 May 2012

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 (1)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: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01147900
Sponsor's protocol ID: 113055
Status last verified: Sep 2016
First submitted: 20 May 2010
Last updated: 20 Aug 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

Vandermeulen C, Theeten H, Rathi N, Kuriyakose S, Han HH, Sokal E, Hoppenbrouwers K, Van Damme P. Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium. Vaccine. 2015 Jun 12;33(26):3026-34. doi: 10.1016/j.vaccine.2014.10.049. Epub 2015 Jan 19.
PubMed 25613716

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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

All Acellular Pertussis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination
ClinicalTrials.gov ID: NCT01147900
Acronym / sponsor ID: 113055
Conditions: Acellular Pertussis, Tetanus, Diphtheria
Keywords: Immune persistence, Boostrix, dTpa booster study
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Jun 2010
Primary completion: 8 May 2012 (actual)
Study completion: 8 May 2012 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 8 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Boostrix-REF Group	Experimental	Biological: Boostrix™Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Boostrix-US Group	Experimental	Biological: Boostrix™-US formulationSubjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Boostrix-INV Group	Experimental	Biological: Boostrix™Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Who may qualify

Ages: 18 to 28 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Male or female subjects who have received Boostrix™, Boostrix™-US formulation or the investigational vaccine formulation in the study 263855/029.
Written informed consent obtained from the subject. Additional criteria to be checked before the booster vaccination.
Healthy subjects as established by medical history and clinical examination.
Female subjects of non-childbearing potential may receive the booster vaccine.

Key exclusion criteria (23 listed)

Previous booster vaccination against diphtheria, tetanus, or pertussis since the dose received in the study 263855/029.
History of diphtheria, tetanus, or laboratory confirmed pertussis disease.
Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.

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, single dose	Biological	Boostrix-INV Group, Boostrix-REF Group
Boostrix™-US formulationIntramuscular, single dose	Biological	Boostrix-US Group

Primary outcome

Number of Seroprotected Subjects Against Diphtheria and Tetanus
Time frame: At Year 8.5
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-D and Anti-T Antibodies.
Time frame: At Year 8.5
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Number of Seroprotected Subjects Against Diphtheria and Tetanus.
Time frame: At Year 10
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-D and Anti-T Antibodies.
Time frame: At Year 10
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.
Time frame: At Year 8.5
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.
Time frame: At Year 8.5
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Time frame: At Year 10
A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Time frame: At Year 10
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Number of Seroprotected Subjects Against Diphtheria and Tetanus
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-D and Anti-T Antibodies.
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).
Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.
Time frame: At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.
Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.
Time frame: At 1 month post Year 10 booster vaccination
A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination. A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL.

5 secondary outcomes

Number of Subjects With Any Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Any Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of Subjects With Any Serious Adverse Events (SAEs).
Time frame: At Year 8.5
Number of Subjects With Any Serious Adverse Events (SAEs).
Time frame: From Year 8.5 up to study end (one month post Year 10 booster vaccination)

Results and safety

Results posted to the registry on 8 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Boostrix-US Group	54	54
Boostrix-INV Group	60	60
Boostrix-REF Group	66	66

Primary outcome: Number of Seroprotected Subjects Against Diphtheria and Tetanus

Time frame: At Year 8.5. Count of participants. Unit: Participants

Measure	Boostrix-US Group n = 54	Boostrix-INV Group n = 59	Boostrix-REF Group n = 65
Anti-D	53	59	65
Anti-T	54	59	65

Population analysed: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

Primary outcome: Concentrations for Anti-D and Anti-T Antibodies.

Time frame: At Year 8.5. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	Boostrix-US Group n = 54	Boostrix-INV Group n = 59	Boostrix-REF Group n = 65
Anti-D	0.912 (0.728 to 1.141)	1.205 (0.984 to 1.474)	0.872 (0.711 to 1.068)
Anti-T	1.889 (1.585 to 2.251)	1.991 (1.674 to 2.368)	1.846 (1.604 to 2.123)

Population analysed: The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.

Primary outcome: Number of Seroprotected Subjects Against Diphtheria and Tetanus.

Time frame: At Year 10. Count of participants. Unit: Participants

Measure	Boostrix-US Group n = 54	Boostrix-INV Group n = 60	Boostrix-REF Group n = 61
Anti-D	53	60	61
Anti-T	54	60	61

Population analysed: The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.

Primary outcome: Concentrations for Anti-D and Anti-T Antibodies.

Time frame: At Year 10. Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	Boostrix-US Group n = 54	Boostrix-INV Group n = 60	Boostrix-REF Group n = 61
Anti-D	0.767 (0.600 to 0.982)	1.099 (0.882 to 1.370)	0.681 (0.550 to 0.844)
Anti-T	2.008 (1.650 to 2.444)	2.009 (1.701 to 2.372)	1.760 (1.518 to 2.041)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs): Entire study period (From Year 8.5 to one month post Year 10) ; Unsolicited adverse events (AEs): During the 31 days (Day 0 - Day 30) post Year 10 booster vaccination; Solicited symptoms: During the 4 days (Day 0 - Day 3) post Year 10 booster vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boostrix-US Group	0 of 55 (0%)	53 of 55 (96.4%)	Not reported
Boostrix-INV Group	0 of 60 (0%)	58 of 60 (96.7%)	Not reported
Boostrix-REF Group	0 of 66 (0%)	58 of 62 (93.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25613716Vandermeulen C, Theeten H, Rathi N, Kuriyakose S, Han HH, Sokal E, Hoppenbrouwers K, Van Damme P. Decennial administration in young adults of a reduced-antigen content diphtheria, tetanus, acellular pertussis vaccine containing two different concentrations of aluminium. Vaccine. 2015 Jun 12;33(26):3026-34. doi: 10.1016/j.vaccine.2014.10.049. Epub 2015 Jan 19.
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

3 sites 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™ and Boostrix™-US formulation in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 3 sites in Belgium.

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 9 inclusion and 23 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. 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 8 Oct 2013). 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 Seroprotected Subjects Against Diphtheria and Tetanus (time frame: At Year 8.5). The study lists 13 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 NCT01147900, 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 20 Aug 2018.