Acellular PertussisPhase 3NCT00346073

Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

A Phase 3 study testing Boostrix™ and ADACEL® in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 42 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. Read more about this study

Who is it for?: Ages 19 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Acellular Pertussis, Diphtheria, Tetanus
What is being tested?: Boostrix™ and ADACEL®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,337 participants
Where: 42 sitesUnited States
Study dates: 13 Jul 2006to 7 Mar 2007
Phase: Phase 3
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 19 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
Administration of a diphtheria-tetanus (Td) booster within previous five years.
Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Alliance, Nebraska, 69301
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Bismarck, North Dakota, 58501
GSK Investigational Site
Boise, Idaho, 83713
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Colorado Springs, Colorado, 80909
GSK Investigational Site
Grove City, Pennsylvania, 16127
GSK Investigational Site
Hickory, North Carolina, 28601
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Kansas City, Missouri, 64114
GSK Investigational Site
Knoxville, Tennessee, 37920
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Mesa, Arizona, 85203
GSK Investigational Site
Mesa, Arizona, 85213
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Norfolk, Virginia, 23507
GSK Investigational Site
North Platte, Nebraska, 69101
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Peoria, Arizona, 85381 - 4828
GSK Investigational Site
Peoria, Illinois, 61602
GSK Investigational Site
Phoenix, Arizona, 85014
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Pueblo, Colorado, 81001
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Richland, Michigan, 49083
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
San Diego, California, 92103-6204
GSK Investigational Site
San Diego, California, 92108
GSK Investigational Site
South Bend, Indiana, 46601
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Tampa, Florida, 33603
GSK Investigational Site
Tempe, Arizona, 85283
GSK Investigational Site
Washington D.C., District of Columbia, 20036
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age

Conditions: Acellular Pertussis, Diphtheria, Tetanus
Being tested: Boostrix™, ADACEL®
Keywords: Prophylaxis for diphtheria, tetanus, pertussis, Immunogenicity, booster, dTpa
Medical subject headings: Diphtheria, Tetanus, Whooping Cough

What participants receive

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

Boostrix™Biological
Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine
ADACEL®Biological
Sanofi Pasteur

Study groups in NCT00346073
Study group	Role	What they receive
Boostrix Group	Experimental	Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0. Receives: Biological: Boostrix™
Adacel Group	Experimental	Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0. Receives: Biological: ADACEL®

What is being measured

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

Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
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 milliliter (IU/mL).
Measured: At Month 1
Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies
A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Measured: At Month 1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: At Month 1
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and < 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.
Measured: At Month 1

Secondary outcomes (11)

Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies
A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to (≥) 1.0 international units per milliliter (IU/mL).
Measured: At Month 1
Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)
Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 0.1 IU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥ 0.4 IU/mL), one month after vaccination; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination.
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 enzyme-linked immunosorbent assay (ELISA) units per milliliter (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 15-day period (Day 0-14) following vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever [defined as temperature measured orally, greater than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [gastro sympt.] and headache. 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 15-day period (Day 0-14) following 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 period (Days 0-30) following 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: During the active phase of the study (Day 0 - Day 30)
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: During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)
Number of Subjects Reporting Hospitalizations
Hospitalization signified that the subject had been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out patient setting.
Measured: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Number of Subjects Reporting Emergency Room Visits
Emergency room visits refer to AEs requiring immediate medical attention.
Measured: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Number of Subjects Reporting the Onset of New Chronic Illnesses
New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.
Measured: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

Timeline

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

13 Jul 20067 Mar 2007

First posted29 Jun 2006 (estimated)
Study start13 Jul 2006
Primary completion1 Mar 2007
Study completion7 Mar 2007

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 2,337 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00346073
Sponsor's protocol ID: 106316
Status last verified: Feb 2018
First submitted: 28 Jun 2006
Last updated: 7 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

Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine. 2009 Jan 29;27(5):765-72. doi: 10.1016/j.vaccine.2008.11.028. Epub 2008 Nov 27.
PubMed 19041352

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 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate Immunogenicity and Safety of Boostrix Compared to Adacel When Administered as a Booster Vaccination in Adults Aged 19 to 64 Years of Age
ClinicalTrials.gov ID: NCT00346073
Acronym / sponsor ID: 106316
Conditions: Acellular Pertussis, Diphtheria, Tetanus
Keywords: Prophylaxis for diphtheria, tetanus, pertussis, Immunogenicity, booster, dTpa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,337 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Jul 2006 (actual)
Primary completion: 1 Mar 2007 (actual)
Study completion: 7 Mar 2007 (actual)
First posted: 29 Jun 2006 (estimated)
Results: Posted 7 Aug 2018

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Boostrix Group	Experimental	Biological: Boostrix™Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Adacel Group	Experimental	Biological: ADACEL®Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.

Who may qualify

Ages: 19 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday) at the time of study vaccination.

Key exclusion criteria (5 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding administration of study vaccine, or planned use during the active phase of the study.
Chronic administration of immunosuppressants or within six months prior to administration of study vaccine.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of study vaccine (with the exception of an influenza vaccine).
Administration of a diphtheria-tetanus (Td) booster within previous five years.
Administration of Tdap vaccine at any time prior to study entry. History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or any component of the study vaccines.

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™Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine	Biological	Boostrix Group
ADACEL®Sanofi Pasteur	Biological	Adacel Group

Primary outcome

Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
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 milliliter (IU/mL).
Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies
Time frame: At Month 1
A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Time frame: At Month 1
Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Time frame: At Month 1
Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and < 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.

11 secondary outcomes

Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies
Time frame: At Month 1
Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)
Time frame: At Month 1
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Time frame: At Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 15-day period (Day 0-14) following vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 15-day period (Day 0-14) following vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day period (Days 0-30) following vaccination
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: During the active phase of the study (Day 0 - Day 30)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)
Number of Subjects Reporting Hospitalizations
Time frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Number of Subjects Reporting Emergency Room Visits
Time frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)
Number of Subjects Reporting the Onset of New Chronic Illnesses
Time frame: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

Results and safety

Results posted to the registry on 7 Aug 2018, 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 Group	1,522	1,481
Adacel Group	762	738

Primary outcome: Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies

Time frame: At Month 1. Count of participants. Unit: Participants

Measure	Boostrix Group n = 1445	Adacel Group n = 728
Anti-D	1418	717
Anti-T	1439	728

Boostrix Group vs Adacel Group: Difference in percentage: -0.43 (95% CI -1.47 to 0.84)
Boostrix Group vs Adacel Group: Difference in percentage: -0.42 (95% CI -0.9 to 0.11)

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Primary outcome: Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies

Time frame: At Month 1. Count of participants. Unit: Participants

Measure	Boostrix Group n = 1445	Adacel Group n = 728
Value	1420	723

Boostrix Group vs Adacel Group: Difference in percentage: -1.04 (95% CI -1.97 to 0)

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Primary outcome: Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

Time frame: At Month 1. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Boostrix Group n = 1444	Adacel Group n = 726
Anti-PT	63.6 (60.1 to 67.4)	32.2 (29.6 to 35.1)
Anti-FHA	624.4 (593.9 to 656.6)	368.4 (344.3 to 394.2)
Anti-PRN	401.0 (368.5 to 436.3)	351.9 (315.7 to 392.2)

Primary outcome: Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies

Time frame: At Month 1. Count of participants. Unit: Participants

Measure	Boostrix Group n = 1441	Adacel Group n = 725
Anti-PT	1095	338
Anti-FHA	1388	671
Anti-PRN	1343	665

Boostrix Group: Booster response: 77.2 (95% CI 74.9 to 79.3)
Boostrix Group: Booster response: 96.9 (95% CI 95.8 to 97.7)
Boostrix Group: Booster response: 93.2 (95% CI 91.8 to 94.4)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boostrix Group	21 of 1,522 (1.4%)	1,108 of 1,522 (72.8%)	1 of 1,522
Adacel Group	13 of 762 (1.7%)	595 of 762 (78.1%)	1 of 762

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19041352Blatter M, Friedland LR, Weston WM, Li P, Howe B. Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age. Vaccine. 2009 Jan 29;27(5):765-72. doi: 10.1016/j.vaccine.2008.11.028. Epub 2008 Nov 27.
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

42 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Boostrix™ and ADACEL® in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 42 sites in United States.

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 1 inclusion and 5 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 7 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 42 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Aug 2018). 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 With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies (time frame: At Month 1). The study lists 4 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 NCT00346073, 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 7 Aug 2018.