A Pragmatic Randomized Trial to Evaluate the Relative Effectiveness of Abrysvo® Revaccination Versus a Single Primary Dose for Preventing RSV-associated Lower Respiratory Tract Disease in Immunocompromised Adults (DAN-RSV IC REVAX)

Conditions

Respiratory syncytial virus infection

Brief summary

Symptomatic RSV-related LRTD, Medically attended RSV event (any setting)

Detailed description

Medically attended RSV event (any setting), Symptomatic RSV-related LRTD, RSV-related RTD ED visit or hospitalization, All-cause RTD ED visit or hospitalization, Primary endpoint stratified by age group (18–59 years and ≥60 years), Primary endpoint and key secondary endpoints in subsequent seasons (September 1 through May 31 of the second and third RSV season following randomization), RSV-related LRTD ED visit or hospitalization, All-cause LRTD ED visit or hospitalization, All-cause symptomatic LRTD or medically attended ARI (any setting), Medically attended ARI (any setting), All-cause symptomatic LRTD, RSV-associated ARI or medically attended RSV event (any setting), All-cause symptomatic or medically attended ARI (any setting), RSV-related RTD hospitalization, All-cause RTD hospitalization, All-cause hospitalization

Related papers

No related papers found yet.

Interventions

DRUGAbrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent

DRUGrecombinant)

DRUGAbrysvo powder and solvent for solution for injection in multidose container Respiratory syncytial virus vaccine (bivalent

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Symptomatic RSV-related LRTD, Medically attended RSV event (any setting)	—

Secondary

Measure	Time frame
Medically attended RSV event (any setting), Symptomatic RSV-related LRTD, RSV-related RTD ED visit or hospitalization, All-cause RTD ED visit or hospitalization, Primary endpoint stratified by age group (18–59 years and ≥60 years), Primary endpoint and key secondary endpoints in subsequent seasons (September 1 through May 31 of the second and third RSV season following randomization), RSV-related LRTD ED visit or hospitalization, All-cause LRTD ED visit or hospitalization, All-cause symptomatic LRTD or medically attended ARI (any setting), Medically attended ARI (any setting), All-cause symptomatic LRTD, RSV-associated ARI or medically attended RSV event (any setting), All-cause symptomatic or medically attended ARI (any setting), RSV-related RTD hospitalization, All-cause RTD hospitalization, All-cause hospitalization	—

Measure

Time frame

Medically attended RSV event (any setting), Symptomatic RSV-related LRTD, RSV-related RTD ED visit or hospitalization, All-cause RTD ED visit or hospitalization, Primary endpoint stratified by age group (18–59 years and ≥60 years), Primary endpoint and key secondary endpoints in subsequent seasons (September 1 through May 31 of the second and third RSV season following randomization), RSV-related LRTD ED visit or hospitalization, All-cause LRTD ED visit or hospitalization, All-cause symptomatic LRTD or medically attended ARI (any setting), Medically attended ARI (any setting), All-cause symptomatic LRTD, RSV-associated ARI or medically attended RSV event (any setting), All-cause symptomatic or medically attended ARI (any setting), RSV-related RTD hospitalization, All-cause RTD hospitalization, All-cause hospitalization

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Outcome results

None listed