Trial · NCT03918629
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity Population (EIP) | Month 7 | EI7 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Neutralization units per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 7 for EIP | Month 7 | EI7 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1 | Up to 7 days after Dose 1 of investigational product at Month 0 | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2 | Up to 7 days after Dose 2 of investigational product at Month 1 | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3 | Up to 7 days after Dose 3 of investigational product at Month 6 | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1 | Up to 7 days after Dose 1 of investigational product at Month 0 | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2 | Up to 7 days after Dose 2 of investigational product at Month 1 | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3 | Up to 7 days after Dose 3 of investigational product at Month 6 | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events Through 1 Month After Last Study Vaccination | From day of first dose up to 1 month after last dose (up to Month 7) | Safety analysis set included all participants who received at least 1 dose of the investigational product. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Events (SAEs) Through 6 Months After Last Study Vaccination | From day of first dose up to 6 months after last dose (up to Month 12) | Safety analysis set included all participants who received at least 1 dose of the investigational product. | Percentage of participants | NUMBER |
| SECONDARY | Adjusted Geometric Mean Concentration for Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibody at Month 12 for EIP | Month 12 | EI12 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Neutralization units per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 12 for EIP | Month 12 | EI12 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Percentage of participants | NUMBER |
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/NCT03918629/outcomes