MVA-BN-RSV vs Placebo: Number of Participants With Unsolicited 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 | 0.0647 | 0.0599 | 0.0698 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0649 | 0.0599 | 0.0701 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000201 | -0.00734 | 0.00692 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.997 | 0.893 | 1.11 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.997 | 0.886 | 1.12 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on MVA-BN-RSV than on Placebo | 4,980 | 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 | MVA-BN-RSV | Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection) | 607 | 9,389 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL) | 581 | 8,959 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Unsolicited Adverse Events | ClinicalTrials.gov |
| Description | Number and percentage of study participants reporting any unsolicited adverse events within 29 days after vaccination. | ClinicalTrials.gov |
| Time frame | Within 29 days after vaccination | ClinicalTrials.gov |
| Population | Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine (multiple enrollers) were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; subjects were analyzed in the placebo arm when having received placebo only. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | MVA-BN-RSV Vaccine Trial | ClinicalTrials.gov |
| NCT number | NCT05238025 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Respiratory Syncytial Virus Infections | ClinicalTrials.gov |
| Interventions | MVA-BN-RSV vaccine, Tris Buffered Saline (TBS) | ClinicalTrials.gov |
| Lead sponsor | Bavarian Nordic | ClinicalTrials.gov |
| Results first posted | 2024-10-31 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05238025?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.