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On December 4, 2023, we reported on findings from a study published in Clinical Infectious Diseases that examined the safety and immunogenicity of RSVpreF when coadministered with seasonal inactivated influenza vaccine (SIIV) compared with administration of either vaccine alone.
The study
Investigators conducted a phase 3 double-blind, placebo-controlled study in healthy adults aged ≥65 years in Australia. Participants were randomly assigned 1:1 to receive both RSVpreF and the SIIV at visit 1 and placebo at visit 2 (1 month later), or, in the sequential administration group, to receive SIIV plus placebo at visit 1 and RSVpreF alone at visit 2.
In total, 1399 participants (mean age, 70 years; 55% women; 95% White) were randomly assigned to receive vaccinations.
Findings
According to the results, local reactions and systemic events were mostly mild or moderate when when RSVpreF was coadministered with SIIV or given alone, and no vaccine-related serious adverse events were reported.
The most common local reaction was injection site pain, which was reported in 11.4%‒12.4% of patients after receiving RSVpreF. The most commonly reported systemic event was fatigue, which was reported in 30% of participants who received RSVpreF and SIIV, 27.1% of patients who received placebo and SIIV, 19.1% of patients who received RSVpreF alone, and 17.6% who received placebo alone.
Authors' comment
“Collectively, these results support coadministration of RSVpreF and SIIV in adults ≥65 years old to help protect against these 2 important respiratory pathogens in this vulnerable population."
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