You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site.

Continue

Go back

AREXVY LOGO

Product menu

SECONDARY ANALYSES

Consistent high efficacy in protecting against RSV-LRTD observed across secondary endpoints1

SEVERE RSV-LRTD

94.1%

(95% CI, 62.37, 99.86)

Efficacy in protecting against severe RSV-LRTD1

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

man sitting down

Not an actual patient.

SUBGROUP ANALYSIS FOR PATIENT’S AGE

93.8%

(95% CI, 60.15, 99.85)

Efficacy in protecting against RSV-LRTD in patients aged 70-79 years1

AREXVY (1 case out of 4487), placebo (16 cases out of 4484)

80.9%

(95% CI, 43.56, 95.25) 

Efficacy in protecting against RSV-LRTD in patients aged 60-69 years1

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

Data are not available for 80+ patient population due to limited total number of cases accrued.1

woman standing with her hands together

Not an actual patient.

RSV-LRTD SUBTYPES

84.6%

(95% CI, 32.08, 98.32)

Efficacy in protecting against RSV A-LRTD1

AREXVY (2 cases out of 12,466), placebo (13 cases out of 12,494)1

80.8%

(95% CI, 49.40, 94.27)

Efficacy in protecting against RSV B-LRTD1

AREXVY (5 cases out of 12,466), placebo (26 cases out of 12,494)1

  • The efficacy of AREXVY against RSV-associated LRTD in adults 60 years and older was evaluated in an ongoing, phase 3, randomised, placebo-controlled, observer-blind clinical study conducted in 17 countries from Northern and Southern Hemispheres. Participants are planned to be followed for up to 36 months.

    The primary population for efficacy analysis (referred to as the modified exposed set, which included adults 60 years of age and older receiving 1 dose of AREXVY or placebo who did not report an RSV-confirmed acute respiratory infection (ARI) prior to Day 15 after vaccination) included 24,960 participants randomised equally to receive 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 baseline, 39.3% of participants had at least 1 comorbidity of interest; 19.7% of participants had an underlying cardiorespiratory condition (COPD, asthma, any chronic respiratory/pulmonary disease, or chronic heart failure) and 25.8% of participants had endocrinometabolic conditions (diabetes, advanced liver or renal disease).

    Definition: RSV-LRTD
    Respiratory syncytial virus–associated lower respiratory tract disease (RSV-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.1

    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%), need for oxygen supplementation.1

    Definition: Severe RSV-LRTD
    Severe RSV-associated LRTD was defined as RT-PCR–confirmed RSV-associated LRTD with at least 2 lower respiratory signs, or as an RT-PCR–confirmed RSV-associated LRTD episode assessed as 'severe' by the investigator.1

    Definition: RSV-ARI
    Acute respiratory infection (ARI) was defined by the presence of at least 2 respiratory symptoms/signs for at least 24 hours, 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.1

VIEW SAFETY INFORMATION

man sitting down

Not an actual patient.

shield

SAFETY

AREXVY was generally well tolerated with an acceptable safety profile. Review the safety findings now.1

LEARN MORE
Lungs

EFFICACY

Review efficacy data against RSV-LRTD for your patients aged 60 years and older.1

LEARN MORE
lungs with particles on right side

VACCINE DESIGN

AREXVY includes both an antigen component and an adjuvant system.1

LEARN MORE

Abbreviations

LRTD=lower respiratory tract disease;
RSV=respiratory syncytial virus.

References

  1. Papi A, Ison MG, Langley JM, et al., for the AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med.202;388(7):595-608. doi:10.1056/ NEJMoa2209604.
  2. Arexvy SPC, available from https://www.medicines.ie/medicines/arexvy-powder-and-suspension-for-suspension-for-injection-35441/spc. Accessed April 2024

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions

Arexvy is a registered trademark of the GlaxoSmithKline group of companies.
©2024 GSK group of companies. All rights reserved

PM-IE-ABX-WCNT-230002 May 2024