Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• The mRNA-1345 vaccine showed significant efficacy in preventing RSV-associated lower respiratory tract disease (LRTD) with at least two signs or symptoms, with a vaccine efficacy of 83.7% (95.88% CI (Confidence Interval), 66.0 to 92.2). For RSV-associated LRTD with at least three signs or symptoms, the vaccine efficacy was 82.4% (96.36% CI, 34.8 to 95.3).
• The vaccine demonstrated an efficacy of 68.4% (95% CI, 50.9 to 79.7) in preventing RSV-associated acute respiratory disease. Protection was consistent across RSV subtypes (A and B) and subgroups defined by age and coexisting conditions, showing broad applicability in adults aged 60 years or older.
• In the mRNA-1345 group, 58.7% of participants experienced local adverse reactions, compared to 16.2% in the placebo group. Systemic adverse reactions were reported in 47.7% of the mRNA-1345 group and 32.9% of the placebo group. Most reactions were mild to moderate in severity and transient.
• Serious adverse events occurred in 2.8% of participants in both the mRNA-1345 and placebo groups, with no notable safety concerns identified.
• There is no population types or subgroups information available in the reviewed studies.