Comparison · NCT02388165-4fcd2668
Staphylococcus Aureus 4-antigen (SA4Ag) vs Placebo: Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1)
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 Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1). Trial comparisons, record NCT02388165-4fcd2668. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02388165-4fcd2668
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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 | 0.0158 | 0.0109 | 0.0229 | wilson | |
| Risk in group 2 | 0.0152 | 0.0104 | 0.0222 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000594 | -0.00795 | 0.00917 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.609 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.604 | 1.79 | log | |
| Number needed to treat, for one more participant with the outcome on Staphylococcus Aureus 4-antigen (SA4Ag) than on Placebo | 1,680 | 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. | 27 | 1,708 | 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. | 26 | 1,709 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1)
- Description
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.
- Time frame
- From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)
- Population
- Safety population: all participants who received investigational product in this study.
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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