Comparison · NCT06060457-0dcbee98
Fluzone HD + mRNA-1345 Followed by Placebo vs Fluzone HD + Placebo Followed by mRNA-1345: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 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 Adverse Reactions (ARs) Within 7 Days After Day 1 Injection. Trial comparisons, record NCT06060457-0dcbee98. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06060457-0dcbee98
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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 | 0.728 | 0.698 | 0.755 | wilson | |
| Risk in group 2 | 0.579 | 0.547 | 0.61 | wilson | |
| Risk difference, group 1 minus group 2 | 0.149 | 0.106 | 0.191 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 1.18 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.94 | 1.6 | 2.36 | log | |
| Number needed to treat, for one more participant with the outcome on Fluzone HD + mRNA-1345 Followed by Placebo than on Fluzone HD + Placebo Followed by mRNA-1345 | 6.72 | 5.25 | 9.43 | 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. | 689 | 947 | 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. | 547 | 945 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
- Description
Solicited ARs were collected in an electronic diary (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 adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section.
- Time frame
- Within 7 days after Day 1 injection
- Population
Day 1 Solicited Safety Set included all randomized participants who received any study intervention on Day 1 and contributed any solicited ARs data from the time of study injection on Day 1 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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