Trial · NCT02545543
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | 28 days after last vaccination. | The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | 28 days after last vaccination. | The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding. | percentage of participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions. | 7 days after each vaccination. | The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs). | 7 days after each vaccination. | The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency of Cellulitis-like Reaction. | 28 days after each vaccination. | The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs). | 28 days after each vaccination. | The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). | 180 days after the last vaccination dose. | The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data | participants | NUMBER |
| SECONDARY | Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit) | 28 days after last vaccination. | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: Seroconversion Rate (SCR) | 28 days after last vaccination. | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | percentage of participants | NUMBER |
| SECONDARY | Immunogenicity Endpoint: Seroprotection Rate | 28 days after last vaccination. | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results | percentage of participants | NUMBER |
| SECONDARY | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) | 28 days after last vaccination. | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Fold Change Titer (GMFI) | GEOMETRIC_MEAN |
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
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GET https://conductscience.org/api/trials/v1/NCT02545543/outcomes