Trial · NCT00346073
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 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 |
| SECONDARY | Number of Subjects With Serious Adverse Events (SAEs). | During the active phase of the study (Day 0 - Day 30) | 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) | During the extended safety follow-up (ESFU) phase (Day 31 - Month 6) | The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. Two subjects were not contacted after the active phase of study, but had SAEs reported in the ESFU period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Hospitalizations | During the extended safety follow-up (ESFU) period (from Day 31 to Month 6) | The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Emergency Room Visits | During the extended safety follow-up (ESFU) period (from Day 31 to Month 6) | The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting the Onset of New Chronic Illnesses | During the extended safety follow-up (ESFU) period (from Day 31 to Month 6) | The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00346073/outcomes