Trial · NCT00489970
Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
NCT00489970, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9. Trials, record NCT00489970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00489970
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
- NCT number
- NCT00489970
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,954 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Interventions
- Taking of blood samples, Boostrix, Adacel
- First posted
- 2007-06-22
- Last updated
- 2020-05-01
- Results first posted
- 2010-08-11
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | At year 1 after the vaccination in primary study (NCT00346073) | Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA) |
| Primary | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | At year 3 after the vaccination in primary study (NCT00346073) | Anti-D cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA |
| Primary | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | At year 5 after the vaccination in primary study (NCT00346073) | Anti-D cut-off was defined as ≥ 0.1IU/mL as assessed by ELISA. |
| Primary | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | At Year 9, one month before the booster vaccination. | Anti-D cut-off was defined as ≥ to 0.1IU/mL as assessed by ELISA. |
| Primary | Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | At year 1 after the vaccination in primary study (NCT00346073) | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | At year 3 after the vaccination in primary study (NCT00346073) | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | At year 5 after the vaccination in primary study (NCT00346073) | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. |
| Primary | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | At Year 9, one month before the booster vaccination. | Anti-T cut-off was defined as ≥ 0.1 IU/mL as assessed by ELISA. |
| Primary | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | At Year 9, one month after the booster vaccination. | Number of subjects with anti-D and anti-T concentrations ≥ 0.1 IU/mL and 1 IU/mL were tabulated |
| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Year 9, one month before booster vaccination | Anti-PT, anti-FHA and anti-PRN antibody concentrations were measured by ELISA, tabulated as GMCs and expressed in IU/mL. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | At year 1 after the vaccination in primary study (NCT00346073) | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | At year 3 after the vaccination in primary study (NCT00346073) | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | At year 5 after the vaccination in primary study (NCT00346073) | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | At Year 9, one month before the booster vaccination. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | At year 1 after the vaccination in primary study (NCT00346073) | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | At year 3 after the vaccination in primary study (NCT00346073) | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | At year 5 after the vaccination in primary study (NCT00346073) | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | At Year 9, one month before the booster vaccination. | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Anti-D and Anti-T Concentrations ≥ 0.1 IU/mL and 1 IU/mL | At Year 9, one month after the booster vaccination. | Analysis was performed on the According-to-Protocol (ATP) Cohort for analysis of immunogenicity at Year 9, which included all subjects who received the dose of study vaccine and for whom assay results were available for antibodies against at least one study vaccine antigen component after Year 9 vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Year 9, one month before booster vaccination | The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available. | IU/mL | GEOMETRIC_MEAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group306
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | Boostrix Group | 967 | Participants | ||
| Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | Adacel Group | 489 | Participants | ||
| Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Boostrix Group | 857 | Participants | ||
| Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Adacel Group | 425 | Participants | ||
| Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Boostrix Group | 735 | Participants | ||
| Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Adacel Group | 359 | Participants | ||
| Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Boostrix Group | 245 | Participants | ||
| Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Adacel Group | 113 | Participants | ||
| Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | Boostrix Group | 1000 | Participants | ||
| Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | Adacel Group | 504 | Participants |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Persistence Year 1 | STARTED | Boostrix Group | 1,069 | |
| Persistence Year 1 | STARTED | Adacel Group | 523 | |
| Persistence Year 1 | STARTED | Control Group | 0 | |
| Persistence Year 1 | COMPLETED | Boostrix Group | 1,069 | |
| Persistence Year 1 | COMPLETED | Adacel Group | 523 | |
| Persistence Year 1 | COMPLETED | Control Group | 0 | |
| Persistence Year 1 | NOT COMPLETED | Boostrix Group | 0 | |
| Persistence Year 1 | NOT COMPLETED | Adacel Group | 0 | |
| Persistence Year 1 | NOT COMPLETED | Control Group | 0 | |
| Persistence Year 3 | STARTED | Boostrix Group | 1,019 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events21
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 | Gastrointestinal disorder | Gastrointestinal disorders | Boostrix Group | 28 | 309 | 28 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Adacel Group | 4 | 138 | 4 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Control Group | 29 | 362 | 29 |
| other | Fatigue | General disorders | Boostrix Group | 71 | 309 | 72 |
| other | Fatigue | General disorders | Adacel Group | 23 | 138 | 23 |
| other | Fatigue | General disorders | Control Group | 51 | 362 | 51 |
| other | Pain | General disorders | Boostrix Group | 181 | 309 | 183 |
| other | Pain | General disorders | Adacel Group | 84 | 138 | 84 |
| other | Pain | General disorders | Control Group | 132 | 362 | 132 |
| other | Swelling | General disorders | Boostrix Group | 57 | 309 | 57 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Boostrix Group | 0 | 309 |
| Total, all-cause mortality | Adacel Group | 0 | 138 |
| Total, all-cause mortality | Control Group | 0 | 362 |
| Total, other adverse events | Boostrix Group | 213 | 309 |
| Total, other adverse events | Adacel Group | 95 | 138 |
| Total, other adverse events | Control Group | 172 | 362 |
| Total, serious adverse events | Boostrix Group | 0 | 309 |
| Total, serious adverse events | Adacel Group | 0 | 138 |
| Total, serious adverse events | Control Group | 1 | 362 |
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 comparisons8
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 Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off | Trial comparisons |
| Boostrix Group vs Adacel Group: Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off | 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/NCT00489970
GET https://conductscience.org/api/trials/v1/NCT00489970/registered?page=2