Trial · NCT00385255
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
NCT00385255, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-09-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults. Trials, record NCT00385255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00385255
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
- NCT number
- NCT00385255
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,726 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus
- Interventions
- Fluarix®, Boostrix®
- First posted
- 2006-10-09
- Last updated
- 2019-06-10
- Results first posted
- 2018-09-17
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | 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. |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | At Month 1 post-Boostrix® vaccination | The assay cut-off value was ≥ 1.0 IU/mL, as assessed by enzyme-linked immunosorbent assay (ELISA). |
| Primary | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | 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). |
| Primary | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | 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. |
| Primary | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | 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. |
| Secondary | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | At Month 1 post-Boostrix® vaccination | A seropositive subject was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value of 1.0 IU/mL. |
| Secondary | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | At Day 0 and Month 1 post-Boostrix® vaccination | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL). |
| Secondary | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | At Day 0 and 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). |
| Secondary | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | At Month 1 post-Boostrix® vaccination | 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®. |
| Secondary | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | At Month 1 post-Boostrix® vaccination | 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®. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | At Month 1 post-Boostrix® vaccination | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | At Month 1 post-Boostrix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | At Month 1 post-Boostrix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | EL.U/mL | GEOMETRIC_MEAN |
| PRIMARY | Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza | At Month 1 post-Fluarix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B | At Month 1 post-Fluarix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value | At Month 1 post-Boostrix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) | At Day 0 and Month 1 post-Boostrix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | IU/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) | At Day 0 and Month 1 post-Boostrix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens | At Month 1 post-Boostrix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens | At Month 1 post-Boostrix® vaccination | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group456
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Boostrix+Fluarix 19-64 YOA Group | Anti-D | 677 | Participants | |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Fluarix Boostrix 19-64 YOA Group | Anti-D | 614 | Participants | |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Boostrix+Fluarix ≥ 65 YOA Group | Anti-D | 93 | Participants | |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Fluarix Boostrix ≥ 65 YOA Group | Anti-D | 79 | Participants | |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Boostrix+Fluarix 19-64 YOA Group | Anti-T | 700 | Participants | |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Fluarix Boostrix 19-64 YOA Group | Anti-T | 653 | Participants | |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Boostrix+Fluarix ≥ 65 YOA Group | Anti-T | 105 | Participants | |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens | Fluarix Boostrix ≥ 65 YOA Group | Anti-T | 95 | Participants | |
| Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | Boostrix+Fluarix 19-64 YOA Group | 687 | Participants | ||
| Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value | Fluarix Boostrix 19-64 YOA Group | 621 | Participants |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Boostrix+Fluarix Group | 860 | |
| Overall Study | STARTED | Fluarix Boostrix Group | 858 | |
| Overall Study | ≥ 65 Years of Age (YOA) Cohort | Boostrix+Fluarix Group | 112 | |
| Overall Study | ≥ 65 Years of Age (YOA) Cohort | Fluarix Boostrix Group | 109 | |
| Overall Study | 19-64 Years of Age (YOA) Cohort | Boostrix+Fluarix Group | 748 | |
| Overall Study | 19-64 Years of Age (YOA) Cohort | Fluarix Boostrix Group | 749 | |
| Overall Study | COMPLETED | Boostrix+Fluarix Group | 839 | |
| Overall Study | COMPLETED | Fluarix Boostrix Group | 785 | |
| Overall Study | NOT COMPLETED | Boostrix+Fluarix Group | 21 | |
| Overall Study | NOT COMPLETED | Fluarix Boostrix Group | 73 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Boostrix+Fluarix Group | 151 | 860 | 152 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fluarix Boostrix Group | 156 | 858 | 186 |
| other | Chills | General disorders | Boostrix+Fluarix Group | 76 | 860 | 76 |
| other | Chills | General disorders | Fluarix Boostrix Group | 86 | 858 | 99 |
| other | Erythema | Skin and subcutaneous tissue disorders | Boostrix+Fluarix Group | 203 | 860 | 203 |
| other | Erythema | Skin and subcutaneous tissue disorders | Fluarix Boostrix Group | 227 | 858 | 303 |
| other | Fatigue | General disorders | Boostrix+Fluarix Group | 240 | 860 | 240 |
| other | Fatigue | General disorders | Fluarix Boostrix Group | 240 | 858 | 306 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Boostrix+Fluarix Group | 139 | 860 | 139 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Fluarix Boostrix Group | 145 | 858 | 171 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Boostrix+Fluarix Group | 0 | 860 |
| Total, all-cause mortality | Fluarix Boostrix Group | 0 | 858 |
| Total, other adverse events | Boostrix+Fluarix Group | 640 | 860 |
| Total, other adverse events | Fluarix Boostrix Group | 619 | 858 |
| Total, serious adverse events | Boostrix+Fluarix Group | 3 | 860 |
| Total, serious adverse events | Fluarix Boostrix Group | 7 | 858 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Boostrix+Fluarix Group vs Fluarix Boostrix Group: deaths from any cause | Trial comparisons |
| Boostrix+Fluarix Group vs Fluarix Boostrix Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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