Exceptional Efficacy For Your Patients 60+1

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Study 1

Primary Endpoint

82.6%

Overall Efficacy Against RSV-LRTD in
Participants 60 Years of Age and Older1
(96.95% CI, 57.9, 94.1)

AREXVY (7 cases out of 12,466),
placebo (40 cases out of 12,494)

Study 1, a phase 3 study, randomized participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494) to evaluate the efficacy of AREXVY in preventing RSV-LRTD in adults 60+.

At the time of this analysis, median follow-up was 6.7 months.1

See full study design provided below

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Study 1

Secondary Endpoint

94.6%

Efficacy Against RSV-LRTD in Participants
60 Years of Age and Older With at Least 1
Comorbidity1*
(95% CI, 65.9, 99.9)

AREXVY (1 case out of 4937),
placebo (18 cases out of 4861)

At the time of this analysis, median follow-up was 6.7 months.1

AREXVY Is the Only RSV Vaccine With Efficacy Data Available Through 3 Full Seasons2-4

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Secondary ENDPOINTS

Seasons 1-3 Vaccine Efficacy for Adults Aged ≥60 Years, With Median Follow-Up of 30.6 Months2

62.9%

RSV-LRTD Overall
(97.5% CI, 46.7, 74.8)

AREXVY (48 cases out of 12,468),
placebo (215 cases out of 12,498)

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64.7%

Participants With at Least 1 Comorbidity of Interest*
(95% CI, 45.1, 78.1)

AREXVY (25 cases out of 5014),
placebo (116 cases out of 4951)

Over 2 RSV seasons in Study 1 (median follow-up of 17.8 months), vaccine efficacy against RSV-LRTD was 67.2% (97.5% CI, 48.2, 80.0; 30/12,469 in AREXVY vs 139/12,498 in placebo) in participants aged 60 years and older, and 66.7% (95% CI, 41.8, 82.0; 16/4983 in AREXVY vs 72/4919 in placebo) in participants with at least 1 comorbidity of interest.1*

Study 1 also evaluated the efficacy of a single dose of AREXVY in preventing RSV-LRTD in adults aged ≥60 years over 3 seasons (median 30.6 months). Pre-Season 2, participants who received AREXVY were re-randomized to receive placebo (n=4991) or a second dose of AREXVY (n=4966). Participants who received placebo before Season 1 received a second dose of placebo before Season 2 (n=10,031). Participants who received a second dose of AREXVY did not contribute to these efficacy analyses after receipt of Dose 2.2,5

*Comorbidities of interest1

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COPD, asthma, or any chronic respiratory/pulmonary disease

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Chronic heart failure

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Diabetes mellitus type 1 or type 2

Advanced liver disease patient

Advanced liver disease

Advanced renal disease patient

Advanced renal disease

Not actual patients.

Comorbidities of interest: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.1

Respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was defined based on the following criteria: the participant must have experienced at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or experienced at least 3 lower respiratory symptoms for at least 24 hours.1

 

Additional Secondary Endpoints 

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AREXVY is the first RSV vaccine approved for patients aged 50-59 years at increased risk for RSV-LRTD1

The immunobridging criteria was met in the comparison of adults 50 to 59 years of age with increased risk for RSV-LRTD to adults 60 years of age and older1

Study 4-Immunobridging

  • STUDY 1 DESIGNSUP1

    The efficacy of AREXVY against respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was evaluated in a phase 3, randomized, placebo-controlled, observer-blind study in individuals aged 60 years and older in 17 countries from Northern and Southern Hemispheres. The primary population for efficacy analysis (referred to as the modified exposed set) included individuals aged 60 years and older receiving 1 dose of AREXVY or placebo and who did not report an RSV-confirmed acute respiratory illness (ARI) prior to Day 15 after vaccination. Participants received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of the primary efficacy analysis, participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months). At the time of first efficacy analysis, the median age of participants was 69 years. At baseline, 39.3% of participants had at least 1 comorbidity of interest. Participants with pre-existing, chronic, stable disease such as diabetes, hypertension, or cardiac disease were allowed to participate in the study if considered by the investigator as medically stable at the time of vaccination. Immunocompromised participants were excluded.

    The primary objective was to demonstrate the efficacy of AREXVY in the prevention of a first episode of confirmed RSV-A and/or B-associated LRTD during the first season. Confirmed RSV cases were determined by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) on a nasopharyngeal swab during all ARI episodes.

    ARI was defined by the presence of at least 2 respiratory symptoms/signs for at least 24 hours (nasal congestion, sore throat, lower respiratory symptoms/signs), or at least 1 respiratory symptom/sign plus 1 systemic symptom/sign (fever or feverishness, fatigue, body aches, headache, decreased appetite) for at least 24 hours.

    LRTD was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥20 respirations/min, low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%), and need for oxygen supplementation.