MVA-BN-RSV vs Placebo: Number of Participants With 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	Source
Risk in group 1	0.0551	0.0506	0.0599	wilson	ClinicalTrials.gov
Risk in group 2	0.0471	0.0429	0.0517	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	0.00796	0.00158	0.0143	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	1.17	1.03	1.33	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	1.18	1.03	1.35	log	ClinicalTrials.gov
Number needed to treat, for one more participant with the outcome on MVA-BN-RSV than on Placebo	126	69.8	632	from the risk difference interval	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)	517	9,389	OG000	ClinicalTrials.gov
Group 2	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)	422	8,959	OG001	ClinicalTrials.gov

Outcome 5

Field	Value	Source
Type	SECONDARY	ClinicalTrials.gov
Title	Number of Participants With Serious Adverse Events	ClinicalTrials.gov
Description	Number and percentage of study participants reporting any serious adverse events at any time during the trial period.	ClinicalTrials.gov
Time frame	From vaccination through study termination, up to 16 months	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

The same record as JSON

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.