Acellular PertussisPhase 3NCT00385255

Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

A Phase 3 study testing Fluarix® and Boostrix® in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 12 sites in United States.

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

The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Acellular Pertussis, Diphtheria, Tetanus
What is being tested?: Fluarix® and Boostrix®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,726 participants
Where: 12 sitesUnited States
Study dates: 23 Oct 2006to 28 Feb 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.

Who cannot join

Administration of an influenza vaccine within six months prior to study entry
Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
Administration of a Tdap vaccine at any time prior to study entry.
Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
History of diphtheria and/or tetanus and/or pertussis disease.
History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Chandler, Arizona, 85224
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Inverness, Florida, 34452
GSK Investigational Site
Melbourne, Florida, 32935
GSK Investigational Site
Mesa, Arizona, 85213
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Peoria, Illinois, 61602
GSK Investigational Site
Phoenix, Arizona, 85014
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, 15220

Other trials in United States

About this study

Official title: A Study to Evaluate Immunogenicity and Safety of Boostrix When Co-administered With Fluarix in Subjects 19 Years of Age and Older

Conditions: Acellular Pertussis, Diphtheria, Tetanus
Being tested: Fluarix®, Boostrix®
Keywords: Immunogenicity,, Influenza, Co-administration,, Tdap,
Medical subject headings: Diphtheria, Tetanus, Influenza, Human

What participants receive

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

Fluarix®Biological
GSK Biologicals' inactivated influenza split virus vaccine.
Boostrix®Biological
GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.

Study groups in NCT00385255
Study group	Role	What they receive
BOOSTRIX+FLUARIX GROUP	Experimental	Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. Receives: Biological: Fluarix®; Biological: Boostrix®
FLUARIX BOOSTRIX GROUP	Experimental	Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. Receives: Biological: Fluarix®; Biological: Boostrix®

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) Toxoid Antigens
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.
Measured: At Month 1 post-Boostrix® vaccination
Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value
The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).
Measured: At Month 1 post-Boostrix® vaccination
Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Measured: At Month 1 post-Boostrix® vaccination
Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza
The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.
Measured: At Month 1 post-Fluarix® vaccination
Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B
Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer.
Measured: At Month 1 post-Fluarix® vaccination

Secondary outcomes (10)

Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value
A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL.
Measured: At Month 1 post-Boostrix® vaccination
Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T)
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL).
Measured: At Day 0 and Month 1 post-Boostrix® vaccination
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN)
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Measured: At Day 0 and Month 1 post-Boostrix® vaccination
Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens
Booster responses for anti-D and anti-T antibodies are defined as: For initially seronegative subjects [pre-vaccination concentration below (<) cut-off 0.1 IU/mL]: antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL), one month after vaccination with Boostrix®; 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 with Boostrix®.
Measured: At Month 1 post-Boostrix® vaccination
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
Booster responses for anti-PT, anti-FHA and anti-PRN are defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL), one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with Boostrix®; For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with Boostrix®.
Measured: At Month 1 post-Boostrix® vaccination
Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers
Anti-H1N1, anti-H3N2 and anti-B antibody titers are presented as geometric mean titers (GMTs).
Measured: At Month 1 post-Fluarix® vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.
Measured: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain, muscle aches and shivering. Any = occurrence of the symptom regardless of intensity grade or relationship to the study vaccination. 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. Subjects from Boostrix+Fluarix Groups (19-64 YOA and ≥ 65 YOA) received only one vaccination dose (Boostrix® vaccine co-administered with Fluarix® vaccine), at Day 0.
Measured: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
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 (Day 0-30) following each vaccination, up to 2 months
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Throughout the whole study period (from Day 0 to Month 2)

Timeline

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

23 Oct 200628 Feb 2007

First posted9 Oct 2006 (estimated)
Study start23 Oct 2006
Primary completion28 Feb 2007
Study completion28 Feb 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 (2)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: None (open label)
Enrolment: 1,726 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00385255
Sponsor's protocol ID: 106323
Status last verified: Jun 2019
First submitted: 6 Oct 2006
Last updated: 10 Jun 2019
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

Weston WM, Chandrashekar V, Friedland LR, Howe B. Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Hum Vaccin. 2009 Dec;5(12):858-66. doi: 10.4161/hv.9961. Epub 2009 Dec 31.
PubMed 19838080
Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31.
PubMed 22212127

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 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate Immunogenicity and Safety of Boostrix When Co-administered With Fluarix in Subjects 19 Years of Age and Older
ClinicalTrials.gov ID: NCT00385255
Acronym / sponsor ID: 106323
Conditions: Acellular Pertussis, Diphtheria, Tetanus
Keywords: Immunogenicity,, Influenza, Co-administration,, Tdap,
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,726 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Oct 2006 (actual)
Primary completion: 28 Feb 2007 (actual)
Study completion: 28 Feb 2007 (actual)
First posted: 9 Oct 2006 (estimated)
Results: Posted 17 Sep 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: None (open label)
Number of arms: 2

Arm	Type	Receives
BOOSTRIX+FLUARIX GROUP	Experimental	Biological: Fluarix®, Biological: Boostrix®Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively.
FLUARIX BOOSTRIX GROUP	Experimental	Biological: Fluarix®, Biological: Boostrix®Healthy male or female adults, aged between 19 to 64 years of age inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.

Key exclusion criteria (6 listed)

Administration of an influenza vaccine within six months prior to study entry
Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
Administration of a Tdap vaccine at any time prior to study entry.
Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
History of diphtheria and/or tetanus and/or pertussis disease.

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
Fluarix®GSK Biologicals' inactivated influenza split virus vaccine.	Biological	BOOSTRIX+FLUARIX GROUP, FLUARIX BOOSTRIX GROUP
Boostrix®GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.	Biological	BOOSTRIX+FLUARIX GROUP, FLUARIX BOOSTRIX GROUP

Primary outcome

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens
Time frame: At Month 1 post-Boostrix® vaccination
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.
Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value
Time frame: At Month 1 post-Boostrix® vaccination
The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA).
Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
Time frame: At Month 1 post-Boostrix® vaccination
Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza
Time frame: At Month 1 post-Fluarix® vaccination
The antibody titer cut-off value for the 3 influenza strains assessed (H1N1, H3N2 and B) was ≥ 1:40.
Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B
Time frame: At Month 1 post-Fluarix® vaccination
Seroconversion for HI antibodies is defined as: For initially seronegative subjects: post-vaccination antibody titer ≥ 1:40 at Month 1 post-Boostrix® vaccination; For initially seropositive subjects: antibody titer at Month 1≥ 4 fold the pre-vaccination antibody titer.

10 secondary outcomes

Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value
Time frame: At Month 1 post-Boostrix® vaccination
Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T)
Time frame: At Day 0 and Month 1 post-Boostrix® vaccination
Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN)
Time frame: At Day 0 and Month 1 post-Boostrix® vaccination
Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens
Time frame: At Month 1 post-Boostrix® vaccination
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens
Time frame: At Month 1 post-Boostrix® vaccination
Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers
Time frame: At Month 1 post-Fluarix® vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day period (Day 0-30) following each vaccination, up to 2 months
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the whole study period (from Day 0 to Month 2)

Results and safety

Results posted to the registry on 17 Sep 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+Fluarix Group	860	839
Fluarix Boostrix Group	858	785

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

Time frame: At Month 1 post-Boostrix® vaccination. Count of participants. Unit: Participants

Measure	Boostrix+Fluarix 19-64 YOA Group n = 713	Fluarix Boostrix 19-64 YOA Group n = 654	Boostrix+Fluarix ≥ 65 YOA Group n = 108	Fluarix Boostrix ≥ 65 YOA Group n = 102
Anti-D	677	614	93	79
Anti-T	700	653	105	95

Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Difference in percentage: 1.06 (95% CI -1.36 to 3.56)
Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Difference in percentage: -1.67 (95% CI -2.96 to -0.74)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Primary outcome: Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value

Time frame: At Month 1 post-Boostrix® vaccination. Count of participants. Unit: Participants

Measure	Boostrix+Fluarix 19-64 YOA Group n = 713	Fluarix Boostrix 19-64 YOA Group n = 654	Boostrix+Fluarix ≥ 65 YOA Group n = 108	Fluarix Boostrix ≥ 65 YOA Group n = 102
Value	687	621	94	84

Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Difference in percentage: 1.40 (95% CI -0.77 to 3.68)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Primary outcome: Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens

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

Measure	Boostrix+Fluarix 19-64 YOA Group n = 713	Fluarix Boostrix 19-64 YOA Group n = 655	Boostrix+Fluarix ≥ 65 YOA Group n = 108	Fluarix Boostrix ≥ 65 YOA Group n = 101
Anti-PT	57.5 (53.1 to 62.3)	76.9 (71.1 to 83.2)	51.2 (40.8 to 64.2)	59.3 (47.0 to 74.8)
Anti-FHA	467.6 (434.9 to 502.8)	663.3 (613.3 to 717.4)	502.5 (409.5 to 616.7)	669.6 (539.1 to 831.8)
Anti-PRN	234.9 (208.7 to 264.3)	343.6 (302.5 to 390.1)	87.9 (60.1 to 128.5)	97.0 (68.1 to 138.4)

Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Adjusted GMC ratio: 0.74 (95% CI 0.67 to 0.82), ANCOVA
Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Adjusted GMC ratio: 0.71 (95% CI 0.64 to 0.79), ANCOVA
Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Adjusted GMC ratio: 0.70 (95% CI 0.60 to 0.81), ANCOVA

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

Primary outcome: Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza

Time frame: At Month 1 post-Fluarix® vaccination. Count of participants. Unit: Participants

Measure	Boostrix+Fluarix 19-64 YOA Group n = 711	Fluarix Boostrix 19-64 YOA Group n = 675	Boostrix+Fluarix ≥ 65 YOA Group n = 108	Fluarix Boostrix ≥ 65 YOA Group n = 103
Anti-H1N1	669	643	92	88
Anti-H3N2	694	663	104	95
Anti-B	685	654	107	101

Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Difference in percentage: -1.17 (95% CI -3.58 to 1.23)
Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Difference in percentage: -0.61 (95% CI -2.22 to 0.96)
Boostrix+Fluarix 19-64 YOA Group vs Fluarix Boostrix 19-64 YOA Group: Difference in percentage: -0.55 (95% CI -2.52 to 1.42)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 15-day (Day 0-14) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Boostrix+Fluarix Group	3 of 860 (0.3%)	640 of 860 (74.4%)	0 of 860
Fluarix Boostrix Group	7 of 858 (0.8%)	619 of 858 (72.1%)	0 of 858

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19838080Weston WM, Chandrashekar V, Friedland LR, Howe B. Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Hum Vaccin. 2009 Dec;5(12):858-66. doi: 10.4161/hv.9961. Epub 2009 Dec 31.
Background: PubMed 22212127Weston WM, Friedland LR, Wu X, Howe B. Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix((R))): results of two randomized trials. Vaccine. 2012 Feb 21;30(9):1721-8. doi: 10.1016/j.vaccine.2011.12.055. Epub 2011 Dec 31.
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

12 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 Fluarix® and Boostrix® in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 12 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 6 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 17 Sep 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 Against Diphteria (D) and Tetanus (T) Toxoid Antigens (time frame: At Month 1 post-Boostrix® vaccination). The study lists 5 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 NCT00385255, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.