Trial · NCT00835237
Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
NCT00835237, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine. Trials, record NCT00835237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835237
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.
- NCT number
- NCT00835237
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,332 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines
- Interventions
- Boostrix®, Decavac™
- First posted
- 2009-02-03
- Last updated
- 2020-01-03
- Results first posted
- 2010-08-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | One month after vaccination. | Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T). Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL) Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL |
| Primary | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration | Before (PRE) and one month after vaccination (POST) | Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL) |
| Secondary | Anti-T and Anti-D Antibody Concentrations | Before (PRE) and one month after vaccination (POST) | Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL. |
| Secondary | Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off | One month after vaccination | Booster response defined as : For initially seronegative subjects (\< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination. For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration. |
| Secondary | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off | One month after vaccination | Booster response defined as : For initially seronegative subjects (\< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination. For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration \< 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration. |
| Secondary | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions. | One month after vaccination | Vaccine response using alternative definitions defined as: For initially seronegative subjects (\< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination. For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration. |
| Secondary | Number of Subjects Reporting Solicited Local Symptoms | Within the 4-day (Day 0-3) post-vaccination period | Solicited local symptoms assessed include pain, redness and swelling. |
| Secondary | Number of Subjects Reporting Solicited General Symptoms | Within the 4-day (Day 0-3) post-vaccination period | Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever |
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AE) | Within the 31-day (Day 0-30) post-vaccination period | An AE is 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. |
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAE) | From the vaccination up to Day 182 | An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. |
Source ClinicalTrials.gov
Outcomes10
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 Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | One month after vaccination. | Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results | subjects | NUMBER |
| PRIMARY | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration | Before (PRE) and one month after vaccination (POST) | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Anti-T and Anti-D Antibody Concentrations | Before (PRE) and one month after vaccination (POST) | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results | IU/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off | One month after vaccination | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results | subjects | NUMBER |
| SECONDARY | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off | One month after vaccination | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results | subjects | NUMBER |
| SECONDARY | Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions. | One month after vaccination | Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Solicited Local Symptoms | Within the 4-day (Day 0-3) post-vaccination period | Analysis was performed on the Total Vaccinated cohort on subjects with available results | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Solicited General Symptoms | Within the 4-day (Day 0-3) post-vaccination period | Analysis was performed on the Total Vaccinated cohort on subjects with available results | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Unsolicited Adverse Events (AE) | Within the 31-day (Day 0-30) post-vaccination period | subjects | NUMBER | |
| SECONDARY | Number of Subjects Reporting Serious Adverse Events (SAE) | From the vaccination up to Day 182 | subjects | NUMBER |
Source ClinicalTrials.gov
Results by group60
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 Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | Boostrix Group | Anti-D (≥ 0.1 IU/mL) (N= 859;432) | 729 | subjects | |
| Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | Decavac Group | Anti-D (≥ 0.1 IU/mL) (N= 859;432) | 374 | subjects | |
| Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | Boostrix Group | Anti-T (≥ 0.1 IU/mL) (N= 864;439) | 836 | subjects | |
| Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | Decavac Group | Anti-T (≥ 0.1 IU/mL) (N= 864;439) | 428 | subjects | |
| Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | Boostrix Group | Anti-T (≥ 1.0 IU/mL) (N= 864;439) | 767 | subjects | |
| Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value | Decavac Group | Anti-T (≥ 1.0 IU/mL) (N= 864;439) | 395 | subjects | |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration | Boostrix Group | Anti-PT (PRE) (N=859;433) | 6.6 | 95% Confidence Interval 6.1 to 7.1 | EL.U/mL |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration | Decavac Group | Anti-PT (PRE) (N=859;433) | 6.5 | 95% Confidence Interval 5.8 to 7.2 | EL.U/mL |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration | Boostrix Group | Anti-PT (POST) (N=852;431) | 49.1 | 95% Confidence Interval 44.9 to 53.7 | EL.U/mL |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration | Decavac Group | Anti-PT (POST) (N=852;431) | 6.4 | 95% Confidence Interval 5.8 to 7.1 | EL.U/mL |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 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 | 887 | |
| Overall Study | STARTED | Decavac Group | 445 | |
| Overall Study | COMPLETED | Boostrix Group | 881 | |
| Overall Study | COMPLETED | Decavac Group | 445 | |
| Overall Study | NOT COMPLETED | Boostrix Group | 6 | |
| Overall Study | NOT COMPLETED | Decavac Group | 0 |
Source ClinicalTrials.gov
Adverse events104
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 | Pain | General disorders | Boostrix Group | 190 | 887 | |
| other | Pain | General disorders | Decavac Group | 123 | 445 | |
| other | Redness | General disorders | Boostrix Group | 95 | 887 | |
| other | Redness | General disorders | Decavac Group | 56 | 445 | |
| other | Swelling | General disorders | Boostrix Group | 66 | 887 | |
| other | Swelling | General disorders | Decavac Group | 52 | 445 | |
| other | Fatigue | General disorders | Boostrix Group | 110 | 887 | |
| other | Fatigue | General disorders | Decavac Group | 66 | 445 | |
| other | Gastrointestinal symptoms | General disorders | Boostrix Group | 67 | 887 | |
| other | Gastrointestinal symptoms | General disorders | Decavac Group | 41 | 445 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Boostrix Group | ||
| Total, all-cause mortality | Decavac Group | ||
| Total, other adverse events | Boostrix Group | 351 | 887 |
| Total, other adverse events | Decavac Group | 202 | 445 |
| Total, serious adverse events | Boostrix Group | 37 | 887 |
| Total, serious adverse events | Decavac Group | 10 | 445 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22212127 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Boostrix Group vs Decavac Group: serious adverse events |
Source 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/NCT00835237
GET https://conductscience.org/api/trials/v1/NCT00835237/results?page=2