Acellular PertussisPhase 4NCT01323959

Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults

A Phase 4 study testing BoostrixTM Polio in people with Acellular Pertussis and Poliomyelitis, run by GlaxoSmithKline at 15 sites in 2 countries.

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

This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio. Read more about this study

Who is it for?: Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for: Acellular Pertussis, Poliomyelitis, Diphtheria
What is being tested?: BoostrixTM Polio
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 212 participants
Where: 15 sitesin 2 countries
Study dates: 1 Apr 2011to 1 Mar 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 25 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who the investigator believes can and will comply with the requirements of the protocol.
Male or female subjects who have received vaccine in study NCT01277705.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject:

Show all 9Show fewer

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

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Group C.

Show all 19Show fewer

History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
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 seven 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 within 48 hours of vaccination,
convulsions with or without fever, occurring within 3 days of vaccination.
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.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

Germany8 sites

GSK Investigational Site
Deggendorf, Bavaria, 94469
GSK Investigational Site
Höhenkirchen-Siegertsbrunn, Bavaria, 85635
GSK Investigational Site
Munich, Bavaria, 80337
GSK Investigational Site
Regensburg, Bavaria, 93053
GSK Investigational Site
Selbitz, Bavaria, 95152
GSK Investigational Site
Vilshofen, Bavaria, 94474
GSK Investigational Site
Weilheim, Bavaria, 82362
GSK Investigational Site
Würzburg, Bavaria, 97070

Other trials in Germany

France7 sites

GSK Investigational Site
Derval, 44590
GSK Investigational Site
La Chapelle-Basse-Mer, 44450
GSK Investigational Site
La Riche, 37250
GSK Investigational Site
Nantes, 44277
GSK Investigational Site
Nantes, 44300
GSK Investigational Site
Tours, 37000
GSK Investigational Site
Tours, 37200

Other trials in France

About this study

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

Read the detailed description

This protocol posting has been updated following protocol amendment 1, dated 03 June 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

Conditions: Acellular Pertussis, Poliomyelitis, Diphtheria, Tetanus
Being tested: BoostrixTM Polio
Keywords: BoostrixTM Polio, dTpa-IPV, booster
Medical subject headings: Poliomyelitis, Diphtheria, Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BoostrixTM PolioBiological
Single dose, intramuscular administration.

Study groups in NCT01323959
Study group	Role	What they receive
BOOSTRIX POLIO GROUP	Experimental	Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. Receives: Biological: BoostrixTM Polio
BOOSTRIX+POLIORIX GROUP	Experimental	Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. Receives: Biological: BoostrixTM Polio
REVAXIS GROUP	Experimental	Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. Receives: Biological: BoostrixTM Polio

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).
Measured: At Month 1
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Measured: At Month 1
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)
Measured: At Day 0
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Measured: At Day 0
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Measured: At Day 0
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
Measured: At Day 0
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 0
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)
Measured: At Day 0

Secondary outcomes (9)

Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration.
Measured: At Month 1
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Measured: At Month 1
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
Measured: At Month 1
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Measured: At Month 1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (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-Day 3) follow-up period after 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-Day 3) follow-up period after 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.
Measured: During the 31-day (Day 0-Day 30) follow-up period after 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: Month 0 - Month 1

Timeline

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

1 Apr 20111 Mar 2012

First posted28 Mar 2011 (estimated)
Study start1 Apr 2011
Primary completion1 Mar 2012
Study completion1 Mar 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: 212 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323959
Sponsor's protocol ID: 113060
Status last verified: Apr 2017
First submitted: 24 Mar 2011
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

Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.
PubMed 25882172

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

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

All Acellular Pertussis trials

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' Boostrix™ Polio in Healthy Adults, 10 Years After a Booster Vaccination
ClinicalTrials.gov ID: NCT01323959
Acronym / sponsor ID: 113060
Conditions: Acellular Pertussis, Poliomyelitis, Diphtheria, Tetanus
Keywords: BoostrixTM Polio, dTpa-IPV, booster
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 212 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Apr 2011
Primary completion: 1 Mar 2012 (actual)
Study completion: 1 Mar 2012 (actual)
First posted: 28 Mar 2011 (estimated)
Results: Posted 3 Aug 2017

Clinical summary

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

Detailed description

This protocol posting has been updated following protocol amendment 1, dated 03 June 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).

Study design

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

Arm	Type	Receives
BOOSTRIX POLIO GROUP	Experimental	Biological: BoostrixTM PolioHealthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
BOOSTRIX+POLIORIX GROUP	Experimental	Biological: BoostrixTM PolioHealthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.
REVAXIS GROUP	Experimental	Biological: BoostrixTM PolioHealthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm.

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subjects who the investigator believes can and will comply with the requirements of the protocol.
Male or female subjects who have received vaccine in study NCT01277705.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.

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 the 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.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

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
BoostrixTM PolioSingle dose, intramuscular administration.	Biological	BOOSTRIX POLIO GROUP, BOOSTRIX+POLIORIX GROUP, REVAXIS GROUP

Primary outcome

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Time frame: At Month 1
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Time frame: At Month 1
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Time frame: At Day 0
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Time frame: At Day 0
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
Time frame: At Day 0
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Time frame: At Day 0
Titers are presented as geometric mean titers (GMTs).
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Time frame: At Day 0
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)

9 secondary outcomes

Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Time frame: At Month 1
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
Time frame: At Month 1
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Time frame: At Month 1
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Time frame: At Month 1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Time frame: At Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Day 0-Day 3) follow-up period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 4-day (Day 0-Day 3) follow-up period after vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: During the 31-day (Day 0-Day 30) follow-up period after vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: Month 0 - Month 1

Results and safety

Results posted to the registry on 3 Aug 2017, 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 Polio Group	67	67
Boostrix+Poliorix Group	72	72
Revaxis Group	72	72

Primary outcome: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens

Time frame: At Month 1. Number. Unit: Subjects

Measure	Boostrix Polio Group n = 63	Boostrix+Poliorix Group n = 69	Revaxis Group n = 69
Anti-D	61	66	68
Anti-T	63	69	69

Boostrix Polio Group: Percentage of subjects seroprotected: 96.8 (95% CI 89 to 99.6)
Boostrix+Poliorix Group: Percentage of subjects seroprotected: 95.7 (95% CI 87.8 to 99.1)
Revaxis Group: Percentage of subjects seroprotected: 100 (95% CI 94.8 to 100)

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.

Primary outcome: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3

Time frame: At Month 1. Number. Unit: Subjects

Measure	Boostrix Polio Group n = 58	Boostrix+Poliorix Group n = 62	Revaxis Group n = 60
Anti-polio 1	58	62	58
Anti-polio 2	46	58	56
Anti-polio 3	58	60	60

Primary outcome: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens

Time frame: At Day 0. Number. Unit: Subjects

Measure	Boostrix Polio Group n = 63	Boostrix+Poliorix Group n = 69	Revaxis Group n = 69
Anti-D	51	50	55
Anti-T	62	68	65

Boostrix Polio Group: Percentage of subjects seroprotected: 92.1 (95% CI 82.4 to 97.4)
Boostrix+Poliorix Group: Percentage of subjects seroprotected: 79.4 (95% CI 67.9 to 88.3)
Revaxis Group: Percentage of subjects seroprotected: 84.1 (95% CI 73.3 to 91.8)

Primary outcome: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3

Time frame: At Day 0. Number. Unit: Subjects

Measure	Boostrix Polio Group n = 58	Boostrix+Poliorix Group n = 66	Revaxis Group n = 67
Anti-polio 1	52	58	59
Anti-polio 2	56	60	62
Anti-polio 3	57	65	67

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms during the 4-day post-vaccination period (Days 0-3), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Month 0 - 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boostrix Polio Group	0 of 67 (0%)	52 of 67 (77.6%)	Not reported
Boostrix+Poliorix Group	0 of 72 (0%)	54 of 72 (75%)	Not reported
Revaxis Group	0 of 72 (0%)	54 of 72 (75%)	Not reported

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.
Derived from this study: PubMed 25882172Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.
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

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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

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BoostrixTM Polio in people with Acellular Pertussis and Poliomyelitis, run by GlaxoSmithKline at 15 sites in 2 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 9 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 15 sites in Germany, France. 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 3 Aug 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 Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens (time frame: At Month 1). The study lists 8 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 NCT01323959, 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 6 Jun 2018.