CO-1

GSK’s RSVPreF3 OA Vaccine (AREXVY)

AREXVY was approved by FDA on May 3, 2023, and is indicated for the prevention 

of LRTD caused by RSV in adults 60 and older, as a single dose.

ACIP June 21, 2023

Leonard Friedland, MD

Vice President, Scientific Affairs and Public Health 

Presentation by GSK at ACIP June 21, 2023
CO-2

Presentation Overview

Efficacy and safety results over 2 full RSV seasons from pivotal Phase 3 Study

▪ 1 dose of AREXVY provides durable efficacy against RSV-associated LRTD over 2 full

RSV seasons, including against severe RSV disease, in adults with underlying 

comorbidities, and across advancing ages

▪ 2

nd dose 12 months after 1st dose does not appear to confer additional efficacy in 

overall population

Immunogenicity and safety results from 2 co-administration trials with influenza 

vaccines (adjuvanted, high dose) 

▪ AREXVY can be administered with all types of commonly used influenza vaccines

LRTD: lower respiratory tract disease Presentation by GSK at ACIP June 21, 2023
CO-3

Pivotal Efficacy and Safety Study (AReSVi-006): 

Results Through 2 Full RSV Seasons

Phase 3, randomized, placebo-controlled, multi-country study to 

demonstrate efficacy and safety of single and annual revaccination 

doses in adults 60 years and older 

Presentation by GSK at ACIP June 21, 2023
CO-4

Ongoing AReSVi-006 Phase 3 Trial Design

Randomized, placebo-controlled, observer-blind, multi-country efficacy study

Adults

≥ 60 years

N = 24,966

AREXVY

(annual group, dose 2)

Placebo

(AREXVY single dose)

R

AREXVY

N = 12,467

Placebo 

N = 12,499

Season 1

2021 – 2022

Season 2

2022 – 2023

Season 3

2023 – 2024

R

AREXVY 

(annual group, dose 3)

Placebo

(AREXVY single dose)

Study Initiated May 2021

(Northern hemisphere)

End of S2 Analysis

Mar 2023

End of S1 Analysis

Apr 2022

Placebo Placebo

*RT-PCR confirmed; †LRTD defined as ≥ 2 lower respiratory symptoms/signs for ≥ 24 hours including ≥1 lower respiratory sign OR ≥ 3 lower 

respiratory symptoms for ≥ 24 hours; RT-PCR: reverse transcriptase polymerase chain reaction

Confirmatory secondary endpoint: Evaluate efficacy of AREXVY in prevention of RSV*-LRTD†in adults ≥ 60 YOA

over 2 seasons, following a single dose of AREXVY and following annual revaccination dose

▪ All RSV-LRTD cases adjudicated by independent external adjudication committee

▪ Success criterion: lower limit of 2-sided 97.5% CI for vaccine efficacy > 20%

Mid-S2 Analysis Nov 

2022

AReSVi-006 

Presentation by GSK at ACIP June 21, 2023
CO-5

AReSVi-006 Case Definitions

ARI

≥ 2 respiratory 

symptoms or signs

OR

≥ 1 respiratory 

and 1 systemic 

symptom or sign for 

at least 24 hours 

Respiratory symptoms or signs

▪ Fever/feverishness

▪ Fatigue

▪ Body aches

▪ Headache

▪ Decreased appetite

Upper respiratory 

symptoms or signs

Lower respiratory 

symptoms

Lower respiratory 

signs

Systemic 

symptoms or signs

▪ Sputum

▪ Cough

▪ Dyspnea

▪ Wheezing

▪ Crackles/rhonchi

▪ Tachypnea

▪ Hypoxemia

▪ O2 supplement

▪ Nasal congestion

▪ Sore throat

LRTD*

≥ 2 lower respiratory symptoms 

or signs 

(≥ 1 sign) 

OR

≥ 3 lower respiratory symptoms 

for at least 24 hours 

▪ Sputum

▪ Cough

▪ Dyspnea

Lower respiratory 

symptoms

Lower respiratory 

signs

▪ Wheezing

▪ Crackles/rhonchi

▪ Tachypnea

▪ Hypoxemia

▪ O2 supplement

Severe LRTD*

≥ 2 lower respiratory signs

OR

episode preventing normal, 

everyday activities

Lower respiratory 

signs

▪ Wheezing

▪ Crackles/rhonchi

▪ Tachypnea

▪ Hypoxemia

▪ O2 supplement

AReSVi-006 

*USPI case definitions Presentation by GSK at ACIP June 21, 2023
CO-6

AREXVY Produces Durable Vaccine Efficacy Against RSV-LRTD 

Over 2 Full Seasons

AReSVi-006 

Median 

Follow-Up

(months)

AREXVY Placebo

VE

(95% CI)

VE

Number of events (95% CI)

Single Dose W/o season 

as covariate#

W/ season 

as covariate¶

Season 1*

VE 1 6.7 7 / 12,466 40 / 12,494 82.6%

(57.9, 94.1)

82.6%

(57.9, 94.1)

Mid Season 2 

Post dose 1 14 15 / 12,469 85 / 12,498 80.9%#

(66.7, 89.8)

77.3%¶

(60.2, 87.9)

Season 2 Only

Post dose 2 6.4 20 / 4,991 91 / 10,031 56.1% 

(28.2, 74.4)

56.1% 

(28.2, 74.4)

Season 1 + 2** 18 30 / 12,469 139 / 12,498 74.5%#

(60.0, 84.5)

67.2%¶

(48.2, 80.0)

Annual (2 doses, ~12 months apart)

Season 2 Only

Post dose 2 6.4 20 / 4,966 91 / 10,031 55.9% 

(27.9, 74.3)

55.9% 

(27.9, 74.3)

Seasons 1 + 2** 18 30 / 12,469 139 / 12,498 74.5%#

(60.0, 84.4)

67.1%¶

(48.1, 80.0)

Modified exposed set 0 20 40 60 80 100

*96.95% CI for VE 1; **97.5% CI for Season 1 + 2 Presentation by GSK at ACIP June 21, 2023
CO-7

AREXVY Produces Durable Vaccine Efficacy Against 

RSV-Severe LRTD Over 2 Full Seasons

AReSVi-006 

Presentation by GSK at ACIP June 21, 2023

Modified exposed set

*96.95% CI for VE 1; **97.5% CI for Season 1 + 2

Median 

Follow-Up

(months)

AREXVY Placebo

VE

(95% CI)

VE

Number of events (95% CI)

Single Dose W/o season 

as covariate#

W/ season 

as covariate¶

Season 1*

VE 1 6.7 1 / 12,466 17 / 12,494 94.1%

(62.4, 99.9)

94.1%

(62.4, 99.9)

Mid Season 2 

Post dose 1 14 4 / 12,469 33 / 12,498 86.8%#

(63.0, 96.6)

84.6%¶

(56.4, 96.1)

Season 2 Only

Post dose 2 6.4 5 / 4,991 28 / 10,031 64.2% 

(6.2, 89.2)

64.2% 

(6.2, 89.2)

Season 1 + 2** 18 7 / 12,469 48 / 12,498 82.7%#

(61.6, 93.4)

78.8%¶

(52.6, 92.0)

Annual (2 doses, ~12 months apart)

Season 2 Only

Post dose 2 6.4 5 / 4,966 28 / 10,031 64.1% 

(5.9, 89.2)

64.1% 

(5.9, 89.2)

Seasons 1 + 2** 18 7 /12,469 48 / 12,498 82.7%#

(61.6, 93.4)

78.8%¶

(52.5, 92.0)

0 20 40 60 80 100
CO-8

AREXVY Produces Durable Vaccine Efficacy Against RSV-LRTD in 

Vulnerable Populations Over 2 Full Seasons

Vaccine efficacy in frail participants cannot be concluded due to low number of cases accrued 

AREXVY Placebo VE

(95% CI)

VE

Number of events (95% CI)

Season 1* 

(Median follow-up = 6.7 months)

≥ 1 pre-existing 

comorbidity of interest 1 / 4,937 18 / 4,861 94.6%(65.9, 99.9)

94.6%

(65.9, 99.9)

Pre-frail 1 / 4,792 14 / 4,778 92.9%

(53.4, 99.8)

92.9%

(53.4, 99.8)

Single dose over 2 seasons† 

(Median follow-up = 18 months)

W/o season 

as covariate#

W/ season 

as covariate¶

≥ 1 pre-existing 

comorbidity of interest 16 / 4,983 72 / 4,919 74.5%#(55.7, 86.1)

66.7%¶

(41.8, 82.0)

Pre-frail 8 / 4,794 47 / 4,779 80.0%#

(57.3, 91.8)

73.3%¶

(42.4, 89.2)

0 20 40 60 80 100

Comorbidities of interest include chronic obstructive pulmonary disease, asthma, any chronic respiratory or pulmonary disease, and chronic heart failure 

(cardiorespiratory condition) and diabetes mellitus type 1 or type 2 and advanced liver or renal disease (endocrine or metabolic condition

*April 2022 analysis; †From 15 days post Dose 1 up to end of Season 2 in Northern Hemisphere

AReSVi-006 

Presentation by GSK at ACIP June 21, 2023
CO-9

AREXVY Placebo VE

(95% CI)

VE

Number of events (95% CI)

Season 1* 

(Median follow-up = 6.7 months)

≥ 60 YOA*** 7 / 12,466 40 / 12,494 82.6% 

(57.9, 94.1)

82.6% 

(57.9, 94.1)

60 – 69 YOA 4 / 6,963 21 / 6,979 81.0%

(43.6, 95.3)

81.0%

(43.6, 95.3)

70 – 79 YOA 1 / 4,487 16 / 4,487 93.8%

(60.2, 99.9)

93.8%

(60.2, 99.9)

Single dose over 2 seasons† 

(Median follow-up = 18 months)

W/o season 

as covariate#

W/ season 

as covariate¶

≥ 60 YOA**** 30 / 12,469 139 / 12,498 74.5%#

(60.0, 84.5) 

67.2%¶

(48.2, 80.0)

60 – 69 YOA 17 / 6,963 74 / 6,981 72.9%#

(53.7, 85.0)

65.4%¶

(40.4, 80.9)

70 – 79 YOA 9 / 4,489 55 / 4,489 80.7%#

(60.6, 91.6)

74.9%¶

(48.4, 89.2)

AREXVY Produces Durable Vaccine Efficacy Against RSV LRTD 

Across Advancing Ages Over 2 Full Seasons

Vaccine efficacy in adults ≥ 80 years of age cannot be concluded due to low number of cases accrued 

0 20 40 60 80 100

*April 2022 analysis; ***96.95% CI; ****97.5% CI; YOA: years of age; 

†From 15 days post Dose 1 up to end of Season 2 in Northern Hemisphere

AReSVi-006 

Presentation by GSK at ACIP June 21, 2023
CO-10

AREXVY Produces Durable Vaccine Efficacy Against RSV-A LRTD 

and RSV-B LRTD Over 2 Full Seasons

*April 2022 analysis; †From 15 days post Dose 1 up to end of Season 2 in Northern Hemisphere

AReSVi-006 

Presentation by GSK at ACIP June 21, 2023

AREXVY Placebo VE

(95% CI)

VE

Number of events (95% CI)

Season 1* 

(Median follow-up = 6.7 months)

RSV-A 2 / 12,466 13 / 12,494 84.6%

(32.1, 98.3)

84.6%

(32.1, 98.3)

RSV-B 5 / 12,466 26 / 12,494 80.9%

(49.4, 94.3)

80.9%

(49.4, 94.3)

Single dose over 2 seasons† 

(Median follow-up = 18 months)

W/o season 

as covariate#

W/ season 

as covariate¶

RSV-A 6 / 12,469 48 / 12,498 85.2%#

(65.4, 94.8)

80.5%¶

(54.0, 93.2)

RSV-B 24 / 12,469 90 / 12,498 68.5%#

(50.2, 80.8)

59.7%¶

(35.8, 75.5)

0 20 40 60 80 100
CO-11

Reactogenicity Profile of 2nd Dose in Line with 1st Dose

Solicited AEs Reported Within 4 Days of Vaccination (Solicited Safety Set)

AREXVY Season 1 n=879; Placebo Season 1 n=878; 2 doses Season 2 n=326 (received AREXVY in Season 1 and Season 2); 

1 dose Season 2 n=345 (received AREXVY in Season 1 and Placebo in Season 2); 

Placebo Season 2 n=666 (received Placebo in Season 1 and Season 2)

AReSVi-006: Season 2 

Presentation by GSK at ACIP June 21, 2023

Local Systemic

8.1

1.1

9.8

0.9 0.1

60.9

9.3

52.1

9.0 7.6 6.0

0.8

7.1

0.3 0.3

18.0

6.4

16.9

5.8 7.2

33.7

16.1

30.1

12.8 12.0

2.0 0.3 1.8 0.3 0.6

27.2

12.6

22.1

12.2 9.0

29.0

8.2

25.2

5.8 7.8

0

20

40

60

80

100

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

RSVPreF3 OA

Placebo

Annual

1 dose

Placebo

Erythema Pain Swelling Arthralgia Fatigue Fever Headache Myalgia

AREXVYAREXVYAREXVYAREXVYAREXVYAREXVYAREXVYAREXVY

2 doses AREXVY

(1st & 2nd season)

1 dose AREXVY (1st season) 

/ Placebo (2nd season)

Placebo

(1st & 2nd season)

1 dose AREXVY 

(1st season)

Season 2

2 doses2 doses2 doses2 doses2 doses2 doses2 doses2 doses

% of 

Participants
CO-12

Safety Profile of 2nd Dose in Line with 1st Dose

Unsolicited AEs, SAEs, fatal SAEs, and pIMDs

AREXVY Season 1 n=12,467; Placebo Season 1 n=12,499; 2 doses Season 2 n=4,966 (received AREXVY in Season 1 and Season 2); 1 dose Season 2 n=4,991 

(received AREXVY in Season 1 and Placebo in Season 2); Placebo Season 2 n=10,033 (received Placebo in Season 1 and Season 2)

DLP: data lock point; pIMD: potential immune-mediated disease

AReSVi-006 

Presentation by GSK at ACIP June 21, 2023

Unsolicited AEs

Within 30 days

SAEs

Up to 6 months post 

vaccination Up to DLP (Season 2)

Fatal SAEs pIMDs

33.0

17.8

28.5

15.8 14.9

4.2 4.0 4.2 4.4 4.6

0.4 0.5 0.4 0.5 0.4 0.3 0.3 0.3 0.4 0.3

0

20

40

60

80

100

AREXVY

Placebo

2 doses

1 dose

Placebo

AREXVY

Placebo

2 doses

1 dose

Placebo

AREXVY

Placebo

2 doses

1 dose

Placebo

AREXVY

Placebo

2 doses

1 dose

Placebo

% of 

Participants

2.0 1.3 2.2 1.1 1.2

Grade 3 2 doses AREXVY

(1st & 2nd season)

1 dose AREXVY (1st season) 

/ Placebo (2nd season)

Placebo

(1st & 2nd season)

1 dose AREXVY 

(1st season)

Season 2
CO-13

Influenza Vaccine Co-administration Studies: 

Immunogenicity and Safety

Open-label, randomized, controlled, multi-country studies to evaluate immune 

response, safety, and reactogenicity of AREXVY when co-administered with 

influenza vaccines in adults aged 60 years and above (RSV OA=ADJ-007) or 

65 years and above (RSV OA=ADJ-008 and RSV OA=ADJ-017)

Presentation by GSK at ACIP June 21, 2023
CO-14

Phase 3 Influenza Vaccine Co-Administration Studies: Designs1−3

Open-label, randomized controlled studies evaluating immunogenicity, safety, and 

reactogenicity of AREXVY co-administered with: 

▪ FLU-QIV (RSV OA=ADJ-007; Southern hemisphere)1

▪ FLU-QIV-HD (RSV OA=ADJ-008; Northern hemisphere)2

▪ FLU-aQIV (RSV OA=ADJ-017; Europe)3

Co-Ad group: Participants receiving single dose of RSVPreF3 OA investigational vaccine and single dose of FLU vaccine at Visit 1. Control group: Participants 

receiving a single dose of FLU vaccine at Visit 1 (Day 1), followed by a single dose of the RSVPreF3 OA investigational vaccine at Visit 2. FLU-aQIV: adjuvanted 

quadrivalent influenza vaccine; FLU-QIV: quadrivalent influenza vaccine; FLU-QIV-HD: quadrivalent influenza vaccine-high dose. 1. ClinicalTrials.gov, 2022. 

NCT04841577. https://clinicaltrials.gov/ct2/show/NCT04841577; 2. ClinicalTrials.gov, 2023. NCT05559476. https://clinicaltrials.gov/ct2/show/NCT05559476; 

3. ClinicalTrials.gov, 2023. NCT05568797. https://clinicaltrials.gov/ct2/show/NCT05568797. Accessed May 2023

Co-administration 

(AREXVY + FLU)

Older Adults

FLU-QIV: ≥ 60 YOA

N = 8681

FLU-QIV-HD: ≥ 65 YOA 

N = 1,0082

FLU-aQIV: ≥ 65 YOA 

N = 1,0263

Control 

(FLU)

Visit 1

(Day 1)

Visit 2 

(Day 31)

Day 61

R

Control

(AREXVY)

Co-Ad

Control 

Co-Ad

Safety Monitoring 

through 6 months

Blood sampling

AREXVY

FLU

Presentation by GSK at ACIP June 21, 2023
CO-15

Co-Administration of AREXVY and Licensed FLU-QIV-HD

*RSV-A preliminary, final results pending

Flu response evaluated using HI and RSV response evaluated using NAb (ED 60); HI: Hemagglutination 

RSV OA=ADJ-008: FLU QIV-HD

Antibody

Co-Ad

N

Control

N

GMT Ratio (Control Over Co-Administration)

1 Month After Vaccination

Per Protocol Set

GMT Ratio

(95% CI)

Flu A/Darwin H3N2 458 441 0.98

(0.84, 1.14)

Flu A/Victoria H1N1 452 435 0.93

(0.80, 1.08)

Flu B/Austria/Victoria 458 441 0.95

(0.88, 1.03)

Flu B/Phuket/Yamagata 456 441 0.92

(0.84, 1.02)

RSV-A* 459 358 1.18 

(1.04, 1.35)

RSV-B 459 357 1.02 

(0.89, 1.16)

0.5 1 1.5

Presentation by GSK at ACIP June 21, 2023

Success Criteria: Upper limit ≤ 1.5 of 2-sided 95% CI for Group GMT Ratio (Control Group divided by Co-Ad Group) 

for RSV vaccine and for each of FLU vaccine strains
CO-16

Co-Administration of AREXVY and Licensed Flu-Adjuvanted QIV 

*Lower HI titers observed than expected, investigation ongoing; **RSV-A preliminary, final results pending

Flu response evaluated using HI and RSV response evaluated using NAb (ED 60); HI: Hemagglutination 

RSV OA=ADJ-017: FLU aQIV

Presentation by GSK at ACIP June 21, 2023

Success Criteria: Upper limit ≤ 1.5 of 2-sided 95% CI for Group GMT Ratio (Control Group divided by Co-Ad Group) 

for RSV vaccine and for each of FLU vaccine strains

Antibody

Co-Ad

N

Control

N

GMT Ratio (Control Over Co-Administration)

1 Month After Vaccination

Per Protocol Set

GMT Ratio

(95% CI)

Flu A/Darwin H3N2* 433 402 1.31

(1.13, 1.52)

Flu A/Victoria H1N1 424 398 1.03

(0.91, 1.18)

Flu B/Austria/Victoria 433 402 0.97

(0.89, 1.05)

Flu B/Phuket/Yamagata 432 402 1.04

(0.95, 1.12)

RSV-A** 475 377 0.98

(0.87, 1.11)

RSV-B 473 377 1.16

(1.03, 1.31)

0.5 1 1.5 2
CO-17

Modified Set: Solicited Local AEs Within 4 Days Post Vaccination

Grade 3: > 100 mm for erythema and swelling; Grade 3 pain: significant pain at rest; prevents normal everyday activities. Fever: temperature ≥ 38.0 C/100.4 F 

by any route (oral, axillary or tympanic); Grade 3 fever: > 39.0 C/102.2 F.

Grade 3 headache, fatigue, myalgia, arthralgia: preventing normal activity

4.0% 4.6%

47.0%

42.5%

4.5% 5.6%

0% 0%

1.2% 0.5%

0% 0.2%

0

20

40

60

80

100

Co-Ad

Visit 1

FLU

Visit 1

Co-Ad

Visit 1

FLU

Visit 1

Co-Ad

Visit 1

FLU

Visit 1

FLU-QIV-HD 

Erythema Swelling Pain

4.3% 4.3%

55.6%

46.3%

4.0% 4.3%

0.2% 0.3%

2.1% 0.3% 0% 0.3% 0

20

40

60

80

100

Co-Ad

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

AREXVY

Visit 2

AREXVY

Erythema Swelling

% of 

Participants

Pain

RSV OA=ADJ-008: FLU QIV-HD

Presentation by GSK at ACIP June 21, 2023

Co-Ad FLU AREXVY Grade 3
CO-18

Exposed Set: Solicited Local AEs Within 7 Days Post Vaccination

4.5% 3.7%

51.7%

44.8%

3.9% 4.3%

0% 0% 0.2% 0% 0% 0% 0

20

40

60

80

100

Co-Ad

Visit 1

FLU

Visit 1

Co-Ad

Visit 1

FLU

Visit 1

Co-Ad

Visit 1

FLU

Visit 1

FLU-aQIV

Erythema Pain Swelling

11.8% 9.5%

65.9%

58.8%

8.7% 6.0%

1.9% 1.3% 0.6% 0.2% 1.0% 0.7%

0

20

40

60

80

100

Co-Ad

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

AREXVY

Visit 2

AREXVY

Erythema Swelling

% of 

Participants

Pain

RSV OA=ADJ-017: FLU aQIV

Grade 3: > 100 mm for erythema and swelling; Grade 3 pain: significant pain at rest; prevents normal everyday activities. Fever: temperature ≥ 38.0 C/100.4 F 

by any route (oral, axillary or tympanic); Grade 3 fever: > 39.0 C/102.2 F.

Grade 3 headache, fatigue, myalgia, arthralgia: preventing normal activity Presentation by GSK at ACIP June 21, 2023

Co-Ad FLU AREXVY Grade 3
CO-19

Modified Set: Solicited Systemic AEs Within 4 Days 

Post Vaccination

Grade 3: >100 mm for erythema and swelling. Grade 3 pain: significant pain at rest; prevents normal everyday activities. 

Fever: temperature ≥ 38.0°C/100.4°F by any route (oral, axillary or tympanic); Grade 3 fever: > 39.0°C/102.2°F.

Grade 3 headache, fatigue, myalgia, arthralgia: preventing normal activity

RSV OA=ADJ-008: FLU QIV-HD

Presentation by GSK at ACIP June 21, 2023

16.1%

13.8% 13.0%

30.5%

22.0% 23.5%

2.1% 0.7% 2.0%

24.3%

17.1% 19.0%

40.2%

34.1%

31.3%

0.7% 0.7% 0.3% 0.9% 1.2% 0.5% 0.2% 0.2% 0.5%

1.9% 0% 0.3% 1.4% 1.4% 0.3%

0

20

40

60

80

100

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Arthralgia Fatigue Fever Headache Myalgia

Solicited Systemic Adverse Events

% of 

Participants

Co-Ad FLU AREXVY Grade 3
CO-20

Exposed Set: Solicited Systemic AEs Within 7 Days 

Post Vaccination

Grade 3: >100 mm for erythema and swelling. Grade 3 pain: significant pain at rest; prevents normal everyday activities. 

Fever: temperature ≥ 38.0°C/100.4°F by any route (oral, axillary or tympanic); Grade 3 fever: > 39.0°C/102.2°F.

Grade 3 headache, fatigue, myalgia, arthralgia: preventing normal activity

RSV OA=ADJ-017: FLU aQIV

Presentation by GSK at ACIP June 21, 2023

25.8%

15.6% 17.1%

45.7%

28.7% 29.9%

2.1% 0.6% 1.1%

32.2%

19.5%

23.7%

39.0%

23.0%

31.9%

0% 0% 0.2% 0.2% 0.2% 0.2% 0.2% 0% 0.2% 0% 0.2% 0% 0% 0.2% 0%

0

20

40

60

80

100

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

Co-Ad

Visit 1

FLU

Visit 1

AREXVY

Visit 2

% of 

Participants

Arthralgia Fatigue Fever Headache Myalgia

Solicited Systemic Adverse Events

Co-Ad FLU AREXVY Grade 3
CO-21

Summary of Findings

1 dose of AREXVY provides durable efficacy against RSV-associated LRTD for 2 full RSV 

seasons, including against severe RSV disease, in adults with underlying comorbidities, and 

across advancing ages

Revaccination after 12 months does not appear to confer additional efficacy benefit for overall 

population; future data will inform optimal timing of revaccination

Reactogenicity and safety profiles of 2nd dose in line with 1st dose; important for future 

revaccination consideration

Across all studies no new cases of GBS, ADEM, or other neuroinflammatory demyelinating 

disorders with additional exposure

Presentation by GSK at ACIP June 21, 2023

AREXVY can be administered with all types of commonly used influenza vaccines
QA-22

AReSVi-004 Phase 3 Trial Design1

*Primary endpoints: NAb geometric mean titers (RSV-A and RSV-B) at Day 1 (pre-vaccination), D31, M6, and M12 post-dose 1; †CMI response in terms of frequency of 

RSVPreF3-specific CD4+ and/or CD8+ T-cells expressing at least 2 activation markers. CD: cluster of differentiation; CMI: cell-mediated immune

1. ClinicalTrials.gov. 2021. NCT04732871. https://clinicaltrials.gov/ct2/show/NCT04732871 (accessed May 2023)

AReSVi-004 

AREXVY: 1 initial dose, annual revaccination Older adults

≥ 60 years

N=1653

Randomized 

3:1:1

AREXVY: 1 initial dose, revaccination M24

AREXVY: 1 dose, no revaccination

Day 1 Month 12 Month 24

Primary objective: Evaluate humoral immune response following 1-dose primary schedule up to 12 months post-dose 1*

Key secondary objectives: Evaluate humoral and CMI† responses following 1-dose primary schedule and revaccination 

doses, up to study end (Month 36)

Safety monitoring: Throughout study

R

Study initiated Feb 2021
QA-23

Immunogenicity Overview Through Month 18 Post Vaccination 

RSV-A Serum Neutralization Titers RSV-B Serum Neutralization Titers RSVPreF3-specific CD4+ T-cells

Timepoint (days)

RSVPreF3 CD4+ T-cells, /10

6 cells (GM) 

GMT (ED60)

GMT (ED60) 

Timepoint (days) Timepoint (days)

0

2000

4000

6000

8000

10000

12000

0 200 400 600

**~10X

**~3X

~6X

0

2000

4000

6000

8000

10000

12000

0 200 400 600

**~8.X

**~2.4X

**~4X

0

500

1000

1500

2000

2500

0 200 400 600

1 dose 2 doses 1 dose 2 doses 1 dose 2 doses

D0 M6 M12 M18 D0 M6 M12 M18 D0 M6 M12 M18

**”~2-4X* **2-3X

**versus before vaccination 1; CD4+ T-cells expressing ≥2 activation markers including ≥1 cytokine among CD40L, 4-1BB, IL-2, TNF-α, IFN-γ, IL-13, IL-17 (events/106

cells; by intracellular staining). ED: Estimated Dilution; ED60: serum dilution inducing 60% inhibition in plaque-forming units; GMT: geometric mean titer; IL: 

interleukin; TNF: tumor necrosis factor

AReSVi-004 

*RSV-A preliminary, final results pending