Study 1 in participants 60 years and older

Secondary Endpoints:

Efficacy by RSV Type, Severity, and Age

Severe RSV-LRTD

94.1%

Efficacy against severe RSV-LRTD1
(95% CI, 62.4, 99.9)

AREXVY (1 case out of 12,466),
placebo (17 cases out of 12,494)

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

67.4%

Seasons 1-3 vaccine efficacy against severe RSV-LRTD overall for adults aged ≥60 years2
(95% CI, 42.4, 82.7)

AREXVY (15 cases out of 12,468),
placebo (75 cases out of 12,498)

Median follow-up was 30.6 months.2

RSV-LRTD by Subtypes

84.6%

Efficacy against RSV A-LRTD1
(95% CI, 32.1, 98.3)

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

80.9%

Efficacy against RSV B-LRTD1
(95% CI, 49.4, 94.3)

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

69.8%

Seasons 1-3 efficacy against RSV A-LRTD for adults aged ≥60 years2
(97.5% CI, 42.2-85.7)

Median follow-up was 30.6 months.

58.6%

Seasons 1-3 efficacy against RSV B-LRTD for adults aged ≥60 years2
(97.5% CI, 35.9-74.1)

Median follow-up was 30.6 months.

Subgroup Analysis for Participant’s Age

81.0%

Efficacy against RSV-LRTD in participants aged 60-69 years1
(95% CI, 43.6, 95.3)

AREXVY (4 cases out of 6963),
placebo (21 cases out of 6979)

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

93.8%

Efficacy against RSV-LRTD in participants aged 70-79 years1
(95% CI, 60.2, 99.9)

AREXVY (1 case out of 4487),
placebo (16 cases out of 4487)

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

60.3%

Seasons 1-3 efficacy against RSV-LRTD for participants aged 60-69 years1,2
(95% CI, 39.5, 74.8)

AREXVY (28 cases out of 6962),
placebo (117 cases out of 6981)

Median follow-up was 30.6 months.

70.6%

Seasons 1-3 efficacy against RSV-LRTD in participants aged 70-79 years1,2
(95% CI, 48.4, 84.3)

AREXVY (15 case out of 4489),
placebo (85 cases out of 4489)

Median follow-up was 30.6 months.

Vaccine Efficacy Over 2 RSV Seasons, With Median Follow-Up of 17.8 Months1,3

  • 78.8% (95% CI, 52.6, 92.0; 7/12,469 in AREXVY vs 48/12,498 in placebo) against severe RSV-LRTD
  • 80.5% (95% CI, 54.0, 93.2; 6/12,469 in AREXVY vs 48/12,498 in placebo) in RSV A-LRTD, 59.7% (95% CI, 35.8, 75.5; 24/12,469 in AREXVY vs 90/12,498 in placebo) in RSV B-LRTD
  • 65.4% (95% CI, 40.4, 80.9; 17/6963 in AREXVY vs 74/6981 in placebo) in participants aged 60-69, 74.9% (95% CI, 48.4, 89.2; 9/4489 in AREXVY vs 55/4489 in placebo) in participants aged 70-79

Vaccine Efficacy (VE) for ≥80 years cannot be reliably estimated due to the low number of cases accrued in this age group.1,2

  • 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 patients 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.

    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 2.2,3

    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.

    Severe RSV-LRTD was defined as an RSV-associated LRTD with at least 2 lower respiratory signs or as an RSV-associated LRTD episode preventing normal, everyday activities or requiring supportive therapy.1

Demonstrated Safety Profile

See the AREXVY safety data

Safety Information