Comparison · NCT02388165-4b4ec743
Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery. Trial comparisons, record NCT02388165-4b4ec743. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02388165-4b4ec743
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0155 | 0.0105 | 0.023 | wilson | |
| Risk in group 2 | 0.0142 | 0.00941 | 0.0214 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00132 | -0.0075 | 0.0102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.616 | 1.94 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.611 | 1.96 | log | |
| Number needed to treat, for one more participant with the outcome on Staphylococcus Aureus 4-antigen (SA4Ag) than on Placebo | 756 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Staphylococcus Aureus 4-antigen (SA4Ag) | Participants randomized to SA4Ag received a single dose of 0.5 mL SA4Ag vaccine intramuscularly, 10 to 60 days prior to their scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure. | 24 | 1,544 | OG000 |
| Group 2 | Placebo | Participants randomized to this arm received placebo containing the vaccine excipients reconstituted in 0.5mL water for injection. It was administered via intramuscular injection, 10 to 60 days prior to scheduled surgery. Participants were followed from vaccination up to 6 months after their spinal surgical procedure. | 22 | 1,547 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery
- Description
SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body, excluding skin incision, fascia, or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 90 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported.
- Time frame
- Day of surgery (Day 1) up to Day 90 after surgery
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
- NCT number
- NCT02388165
- Phases
- PHASE2
- Conditions
- Staphylococcal Vaccine
- Interventions
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2020-09-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02388165?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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