MVA-BN-RSV vs Placebo: Occurrence of Severe PCR Confirmed RSV-associated LRTD
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 | 0 | 0.000419 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.000218 | 0.0000597 | 0.000793 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000218 | -0.000793 | 0.00023 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to treat, for one fewer participant with the outcome on MVA-BN-RSV than on Placebo | 4,594 | 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) | 0 | 9,160 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL) | 2 | 9,188 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Occurrence of Severe PCR Confirmed RSV-associated LRTD | ClinicalTrials.gov |
| Description | Severe RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR): 1) hypoxemia (oxygen saturation \<92% at rest in conjunction with an at least 3% decrease from baseline); 2) respiratory rate \>25 breaths/Min; 3) imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia | ClinicalTrials.gov |
| Time frame | From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months | ClinicalTrials.gov |
| Population | Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine (multiple enrollers) were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization. | 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.