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AREXVY was generally well tolerated1

Solicited adverse reactions from Study AReSVi-006: Percentage of participants with solicited adverse reactions (<10%) within 4 days of vaccination in adults ≥60 years of age

  AREXVY % (n) Placebo % (n)
Local Adverse Reactions N=879 N=874
Pain, Grade 3* 1 (9) 0
Erythema, >20 mm 7.5 (66) 0.8 (7)
Erythema, >100 mm 0.2 (2) 0
Swelling, >20 mm 5.5 (48) 0.6 (5)
Swelling, >100 mm 0.2 (2) 0
  AREXVY % (n) Placebo % (n)
Systemic Adverse Reactions N=879 N=878
Fatigue, Grade 3† 1.7 (15) 0.5 (4)
Myalgia, Grade 3† 1.4 (12) 0.3 (3)
Headache, Grade 3† 1.3 (11) 0
Arthralgia, Grade 3† 1.3 (11) 0.6 (5)
Fever, Grade 3‡ 0.1 (1) 0.1 (1)

Adapted from Product Monograph1

* Any grade pain: Grade 1 (mild) defined as any pain neither interfering with nor preventing normal everyday activities, Grade 2 (moderate) defined as painful when limb is moved and interferes with everyday activities, or Grade 3 (severe) defined as significant pain at rest and prevents normal everyday activities.
† Any grade fatigue, myalgia, headache, arthralgia: Grade 1 (mild) defined as event easily tolerated, Grade 2 (moderate) defined as interfering with normal activity, or Grade 3 (severe) defined as preventing normal activity.
‡ Fever defined as a temperature ≥38.0°C/100.4°F by any route (oral, axillary, or tympanic); Grade 3 fever defined as >39.0°C/102.2°F.

A subset of study participants (solicited safety set) was monitored for solicited adverse reactions using standardized paper diary cards during the 4 days (i.e., day of vaccination and the next 3 days) following a dose of AREXVY or placebo; 879 adults received AREXVY and 874 adults received placebo.

The local administration site and systemic adverse reactions reported with AREXVY were, in general, mild to moderate, of short duration, and transient in nature (median duration of 2 days and 1–2 days, respectively).1

In Study AReSVi-006, the most commonly reported (≥10%) adverse reactions in participants 60 years of age and older were:1

  • injection site pain, any* (60.9% vs. 9.3% for placebo)
  • fatigue, any† (33.6% vs. 16.1% for placebo)
  • myalgia, any† (28.9% vs. 8.2% for placebo)
  • headache, any† (27.2% vs. 12.6% for placebo)
  • arthralgia, any† (18.1% vs. 6.4% for placebo)

* Any grade pain: Grade 1 (mild) defined as any pain neither interfering with nor preventing normal everyday activities, Grade 2 (moderate) defined as painful when limb is moved and interferes with everyday activities, or Grade 3 (severe) defined as significant pain at rest and prevents normal everyday activities.
† Any grade fatigue, myalgia, headache, arthralgia: Grade 1 (mild) defined as event easily tolerated, Grade 2 (moderate) defined as interfering with normal activity, or Grade 3 (severe) defined as preventing normal activity.

Serious adverse events from Study AReSVi-006

Study participants were monitored for all serious adverse events (SAEs) that occurred during the 6-month period following administration of AREXVY (n=12,467) or placebo (n=12,499). SAEs were reported in adults who received AREXVY (4.2%) or placebo (4.0%).1
MAGNIFYING GLASS ICON

See AREXVY efficacy data

Efficacy of AREXVY against RSV-associated LRTD in adults 60 years and older was evaluated in Study AReSVi-006.1

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ICON OF MEDICATION BOTTLES AND SYRINGE

Getting started with AREXVY

Learn about proper reconstitution, administration, and storage information for AREXVY.

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Reference:

  1. AREXVY Product Monograph. GlaxoSmithKline Inc.

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104605 | 07/24

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