MVA-BN-RSV vs Placebo: Number of Participants With Grade 3 or Higher 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	0.00117	0.000654	0.0021	wilson	ClinicalTrials.gov
Risk in group 2	0.000223	0.0000612	0.000814	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	0.000948	0.000163	0.00189	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	5.25	1.16	23.7	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	5.25	1.16	23.7	log	ClinicalTrials.gov
Number needed to treat, for one more participant with the outcome on MVA-BN-RSV than on Placebo	1,050	530	6,120	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)	11	9,389	OG000	ClinicalTrials.gov
Group 2	Placebo	Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)	2	8,959	OG001	ClinicalTrials.gov

Outcome 5

Field	Value	Source
Type	SECONDARY	ClinicalTrials.gov
Title	Number of Participants With Grade 3 or Higher Adverse Events	ClinicalTrials.gov
Description	Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse events assessed as related to study vaccine	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

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.