Trial · NCT00346073
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
NCT00346073, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-08-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years. Trials, record NCT00346073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00346073
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
- NCT number
- NCT00346073
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,337 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus
- Interventions
- Boostrix™, ADACEL®
- First posted
- 2006-06-29
- Last updated
- 2018-08-07
- Results first posted
- 2018-08-07
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 With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | 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). |
| Primary | Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies | 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). |
| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | 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). |
| Primary | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | 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. |
| Secondary | Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies | 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). |
| Secondary | Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | At Month 1 | 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. |
| Secondary | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | At Month 1 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 15-day period (Day 0-14) following vaccination | 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. |
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 15-day period (Day 0-14) following vaccination | 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. |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day period (Days 0-30) following vaccination | 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. |
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 With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | At Month 1 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies | At Month 1 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Month 1 | 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. The primary outcome results only refer to subjects who received a Boostrix vaccination. | EL.U/mL | GEOMETRIC_MEAN |
| PRIMARY | Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | At Month 1 | 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. The primary outcome results only refer to subjects who received a Boostrix vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies | At Month 1 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) | At Month 1 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | At Month 1 | 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. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 15-day period (Day 0-14) following vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 15-day period (Day 0-14) following vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day period (Days 0-30) following vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group76
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 With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Boostrix Group | Anti-D | 1418 | Participants | |
| Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Adacel Group | Anti-D | 717 | Participants | |
| Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Boostrix Group | Anti-T | 1439 | Participants | |
| Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Adacel Group | Anti-T | 728 | Participants | |
| Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies | Boostrix Group | 1420 | Participants | ||
| Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies | Adacel Group | 723 | Participants | ||
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Boostrix Group | Anti-PT | 63.6 | 95% Confidence Interval 60.1 to 67.4 | EL.U/mL |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Adacel Group | Anti-PT | 32.2 | 95% Confidence Interval 29.6 to 35.1 | EL.U/mL |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Boostrix Group | Anti-FHA | 624.4 | 95% Confidence Interval 593.9 to 656.6 | EL.U/mL |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Adacel Group | Anti-FHA | 368.4 | 95% Confidence Interval 344.3 to 394.2 | EL.U/mL |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Boostrix Group | 1,522 | |
| Overall Study | STARTED | Adacel Group | 762 | |
| Overall Study | COMPLETED | Boostrix Group | 1,481 | |
| Overall Study | COMPLETED | Adacel Group | 738 | |
| Overall Study | NOT COMPLETED | Boostrix Group | 41 | |
| Overall Study | NOT COMPLETED | Adacel Group | 24 |
Source ClinicalTrials.gov
Adverse events100
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 | Erythema | Skin and subcutaneous tissue disorders | Boostrix Group | 313 | 1,522 | 313 |
| other | Erythema | Skin and subcutaneous tissue disorders | Adacel Group | 201 | 762 | 201 |
| other | Fatigue | General disorders | Boostrix Group | 419 | 1,522 | 420 |
| other | Fatigue | General disorders | Adacel Group | 214 | 762 | 214 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Boostrix Group | 235 | 1,522 | 235 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Adacel Group | 130 | 762 | 130 |
| other | Headache | Nervous system disorders | Boostrix Group | 448 | 1,522 | 450 |
| other | Headache | Nervous system disorders | Adacel Group | 230 | 762 | 232 |
| other | Pain | General disorders | Boostrix Group | 905 | 1,522 | 917 |
| other | Pain | General disorders | Adacel Group | 516 | 762 | 530 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Boostrix Group | 1 | 1,522 |
| Total, all-cause mortality | Adacel Group | 1 | 762 |
| Total, other adverse events | Boostrix Group | 1,108 | 1,522 |
| Total, other adverse events | Adacel Group | 595 | 762 |
| Total, serious adverse events | Boostrix Group | 21 | 1,522 |
| Total, serious adverse events | Adacel Group | 13 | 762 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19041352 | BACKGROUND |
Source PubMed
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Boostrix Group vs Adacel Group: Number of Subjects With Serious Adverse Events (SAEs). | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Any Unsolicited Adverse Events (AEs) | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects Reporting Emergency Room Visits | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects Reporting Hospitalizations | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Serious Adverse Events (SAEs) | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects Reporting the Onset of New Chronic Illnesses | Trial comparisons |
| Boostrix Group vs Adacel Group: deaths from any cause | Trial comparisons |
| Boostrix Group vs Adacel 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.
GET https://conductscience.org/api/trials/v1/NCT00346073
GET https://conductscience.org/api/trials/v1/NCT00346073/results?page=2