Trial · NCT00385255
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| SECONDARY | Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers | 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. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months | 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 (Day 0-14) period following each dose and across doses, up to 2 months | 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 (Day 0-30) following each vaccination, up to 2 months | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Serious Adverse Events (SAEs) | Throughout the whole study period (from Day 0 to Month 2) | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00385255/outcomes