Trial · NCT02388165
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery | Day of surgery (Day 1) up to Day 90 | Per-protocol (PP) efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Within 10 days after Vaccination | Safety population: all participants who received investigational product in this study. Here, Overall Number of Participants Analyzed, N signifies number of participants analyzed for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination | Within 10 days after Vaccination | Safety population: all participants who received investigational product in this study. Here, Overall Number of Participants Analyzed signifies number of participants analyzed for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1) | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42 | From vaccination until Day 42 after surgery (52-102 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42 | Day of surgery (Day 1) up to Day 42 after surgery | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180 | Day 42 up to Day 180 (up to 138 days) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180 | From vaccination up to Day 180 after surgery (190-240 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1) | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180 | Day of surgery (Day 1) up to Day 180 after surgery | Safety population: all participants who received investigational product in this study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Postoperative S. Aureus Blood Stream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery | Day of surgery (Day 1) up to Day 180 after surgery | PP efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery | Day of surgery (Day 1) up to Day 90 after surgery | PP efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery | Day of surgery (Day 1) up to Day 180 after surgery | PP efficacy population: all eligible participants, vaccinated as randomized, who underwent surgery per study-defined criteria within 9-90 days (inclusive) post vaccination (expanded from 10-60 days window in protocol), had no infection/malignancy at surgery and had no major protocol violation prior to reporting S. aureus infection. | 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/NCT02388165/outcomes