VCIV vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.008 | 0.00558 | 0.0115 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00746 | 0.00513 | 0.0108 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000546 | -0.00361 | 0.00472 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.637 | 1.81 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.07 | 0.634 | 1.82 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on VCIV than on Placebo | 1,830 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | VCIV | Vero cell-derived, trivalent, seasonal influenza vaccine~Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection | 29 | 3,623 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Phosphate-buffered saline~Placebo: Phosphate-buffered saline: Single intramuscular injection | 27 | 3,620 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection | ClinicalTrials.gov |
| NCT number | NCT00800605 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza | ClinicalTrials.gov |
| Interventions | Vero cell-derived, trivalent, seasonal influenza vaccine, Placebo: Phosphate-buffered saline | ClinicalTrials.gov |
| Lead sponsor | Alachua Government Services, Inc. | ClinicalTrials.gov |
| Results first posted | 2025-11-24 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00800605?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.