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+AReSVi-006 Efficacy against RSV-associated LRTD in adults 60 years and older was evaluated for up to 3 RSV seasons in a Phase III, randomised, placebo-controlled, observer-blind clinical study conducted in 17 countries from Northern and Southern Hemispheres.
Pre-Season 2, participants who received Arexvy during the first season were re-randomised to receive placebo (N= 4 991) or a second dose of Arexvy (N= 4 966). Participants who received placebo before Season 1 received a second dose of placebo before Season 2. The participants were followed up to the end of the third RSV season (median follow-up time 30.6 months).
*Vaccination does not protect all recipients1
†*comorbidities of interest2: Chronic obstructive pulmonary disease (COPD), asthma, any other chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2 or liver or renal diseases (endocrinometabolic).1
Efficacy against RSV-associated LRTD in adults 60 years and older was evaluated for up to 3 RSV seasons in a Phase III, randomised, placebo-controlled, observer-blind clinical study conducted in 17 countries from Northern and Southern Hemispheres. Overall, 24 960 participants were randomised equally to receive 1 dose of Arexvy (N= 12 466) or placebo (N= 12 494) during the first season.
CI = Confidence Interval; LRTD = Lower Respiratory Tract Disease; RSV = Respiratory Syncytial Virus.
COPD, asthma, or any chronic respiratory/pulmonary disease
Chronic heart failure
Diabetes mellitus type 1 or type 2
Advanced liver or renal disease
Not actual patients.
Administration and storage
Arexvy is administered as a single 0.5 mL intramuscular dose, preferably in the deltoid muscle. Very common side effects (≥1/10): Headache, myalgia, arthralgia, injection site pain, injection site erythema, fatigue. Common side effects (≥1/100 to <1/10): injection site swelling, fever, chills. Uncommon side effects (≥1/1000 to <1/100): lymphadenopathy, hypersensitivity reactions, nausea, abdominal pain, vomiting, injection site pruritus, pain, malaise. Medical supervision is advised for potential anaphylaxis. Vaccination should be postponed during acute febrile illness. Anxiety-related reactions may occur. Caution in individuals with thrombocytopenia or coagulation disorder. Safety and immunogenicity data are not available for immunocompromised individuals. Patients with immunodeficiency or on immunosuppressive treatment may have a reduced immune response to Arexvy. No data on the effects on human fertility. Not recommended during pregnancy or in breast-feeding/lactating women.1
Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in adults aged 60 years and older (solicited safety set with 4-day diary card, N=1757)2,3
|
AREXVY % |
Placeboa % |
Local Adverse Reactions |
N=879 |
N=874 |
|---|---|---|
Pain, Anyb |
60.9 |
9.3 |
Pain, Grade 3b |
1 |
0 |
Erythema, >20 mm |
7.5 |
0.8 |
Erythema, >100 mm |
0.2 |
0 |
Swelling, >20 mm |
5.5 |
0.6 |
Swelling, >100 mm |
0.2 |
0 |
|
AREXVY % |
Placeboa % |
Systemic Adverse Reactions |
N=879 |
N=878 |
|---|---|---|
Fatigue, Anyc |
33.6 |
16.1 |
Fatigue, Grade 3c |
1.7 |
0.5 |
Myalgia, Anyc |
28.9 |
8.2 |
Myalgia, Grade 3c |
1.4 |
0.3 |
Headache, Anyc |
27.2 |
12.6 |
Headache, Grade 3c |
1.3 |
0 |
Arthralgia, Anyc |
18.1 |
6.4 |
Arthralgia, Grade 3c |
1.3 |
0.6 |
Fever, ≥38.0 °C/100.4 °Fd |
2.0 |
0.3 |
Fever, >39.0 °C/102.2 °Fd |
0.1 |
0.1 |
N=exposed set for solicited safety set included all participants with at least 1 documented dose.
aPlacebo was a saline solution.
bAny grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).
cAny grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).
dTemperature taken by any route (oral, axillary, or tympanic).
Wholesalers in Ireland:
Abbreviations:
RSV=respiratory syncytial virus; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease.
POM. Further information is available from GlaxoSmithKline (Ireland) Ltd
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 or via online form https://gsk.public.reportum.com/.
▼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.
©2025 GSK group of companies. All rights reserved.
PM-IE-ABX-WCNT-230001 | September 2025
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