Expanded Patient Population

The First RSV Vaccine Approved for Patients 50–59 Years of Age Who Are at Increased Risk* for RSV-LRTD1

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Study 4 Design – Immunobridging

In Study 4, individuals 50 through 59 years of age with chronic medical conditions (chronic pulmonary disease, chronic cardiovascular disease, diabetes, or chronic kidney or liver disease) were randomized to receive AREXVY (n=386) or saline placebo (n=191). A comparator group of individuals 60 years and older also received AREXVY (n=381).

Effectiveness of AREXVY in individuals 50 through 59 years of age with chronic medical conditions was assessed by a comparison of RSV neutralizing antibody responses induced by AREXVY in this age group to antibody responses of individuals 60 years of age and older. 

The neutralizing antibody responses to RSV-A and RSV-B subtypes in individuals 50 through 59 years of age with chronic medical conditions met the criteria for immunobridging, as the upper limit (UL) of the 2-sided 95% CI for the GMT ratio (GMT for individuals 60 years and older/GMT for individuals 50 through 59 years of age with chronic medical conditions) was ≤1.50 and the UL of the 2-sided 95% CIs for seroresponse rate (SRR) difference (SRR for individuals 60 years and older minus SRR for individuals 50 through 59 years of age with chronic medical conditions) was ≤10% for the RSV-A and RSV-B subtypes.


*Medical conditions defined as1:

Chronic pulmonary disease

Chronic liver disease 

Chronic cardiovascular disease

Chronic kidney disease

diabetes

Diabetes

Not actual patients.

Medical conditions defined as chronic pulmonary disease, chronic liver disease, chronic cardiovascular disease, chronic kidney disease, or diabetes.1