Comparison · NCT06060457-d71c4105
Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection. Trial comparisons, record NCT06060457-d71c4105. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06060457-d71c4105
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.273 | 0.245 | 0.303 | wilson | |
| Risk in group 2 | 0.612 | 0.58 | 0.643 | wilson | |
| Risk difference, group 1 minus group 2 | -0.339 | -0.381 | -0.295 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.446 | 0.397 | 0.502 | log | |
| Odds ratio, group 1 over group 2 | 0.238 | 0.196 | 0.29 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fluzone HD + mRNA-1345 Followed by Placebo than on Fluzone HD + Placebo Followed by mRNA-1345 | 2.95 | 2.63 | 3.39 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Fluzone HD + mRNA-1345 Followed by Placebo | Participants received Fluzone HD + mRNA-1345 by IM injection on Day 1 followed by placebo by IM injection on Day 22. | 251 | 919 | OG000 |
| Group 2 | Fluzone HD + Placebo Followed by mRNA-1345 | Participants received Fluzone HD + placebo by IM injection on Day 1 followed by mRNA-1345 by IM injection on Day 22. | 557 | 910 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection
- Description
Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section.
- Time frame
- Within 7 days after Day 22 injection
- Population
Day 22 Solicited Safety Set included all randomized participants who received any study intervention on Day 22 and contributed any solicited ARs data from the time of study injection on Day 22 through the following 6 days. Participants were included in the treatment arm corresponding to the study drug they actually received.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
- NCT number
- NCT06060457
- Phases
- PHASE3
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Placebo, mRNA-1345, Fluzone HD
- Lead sponsor
- ModernaTX, Inc.
- Results first posted
- 2025-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06060457?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.
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