Document text
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
▪2nddose 12 months after 1stdose 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 = 12,4 67
Placebo
N = 12,499Season 1
2021 –2022Season 2
2022 –2023Season 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 reactionConfirmatory 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
2022AReSVi -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 appetiteUpper respiratory
symptoms or signsLower respiratory
symptomsLower respiratory
signsSystemic
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
▪DyspneaLower respiratory
symptomsLower respiratory
signs
▪Wheezing
▪Crackles/rhonchi
▪Tachypnea
▪Hypoxemia
▪O2 supplement
Severe LRTD*
≥ 2 lower respiratory signs
OR
episode preventing normal,
everyday activitiesLower respiratory
signs
▪Wheezing
▪Crackles/rhonchi
▪Tachypnea
▪Hypoxemia
▪O2 supplementAReSVi -006
Presentation by GSK at ACIP June 21, 2023 *USPI case definitions
CO-6
AREXVY Produces Durable Vaccine Efficacy Against RSV -LRTD
Over 2 Full SeasonsAReSVi -006
Median
Follow -Up
(months)AREXVY Placebo
VE
(95% CI)VE
(95% CI) Number of events
Single DoseW/o season
as covariate#W/ season
as covariate¶
Season 1*
VE 16.7 7 / 12,466 40 / 12,49482.6%
(57.9, 94.1)82.6%
(57.9, 94.1)
Mid Season 2
Post dose 114 15 / 12,469 85 / 12,49880.9%#
(66.7, 89.8)77.3%¶
(60.2, 87.9)
Season 2 Only
Post dose 26.4 20 / 4,991 91 / 10,03156.1%
(28.2, 74.4)56.1%
(28.2, 74.4)
Season 1 + 2** 18 30 / 12,469 139 / 12,49874.5%#
(60.0, 84.5)67.2%¶
(48.2, 80.0)
Annual (2 doses, ~12 months apart)
Season 2 Only
Post dose 26.4 20 / 4,966 91 / 10,03155.9%
(27.9, 74.3)55.9%
(27.9, 74.3)
Seasons 1 + 2** 18 30 / 12,469 139 / 12,49874.5%#
(60.0, 84.4)67.1%¶
(48.1, 80.0)
0 20 40 60 80 100Modified exposed set
*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 SeasonsAReSVi -006
Presentation by GSK at ACIP June 21, 2023Modified exposed set
*96.95% CI for VE 1 ;**97.5% CI for Season 1 + 2Median
Follow -Up
(months)AREXVY Placebo
VE
(95% CI)VE
(95% CI) Number of events
Single DoseW/o season
as covariate#W/ season
as covariate¶
Season 1*
VE 16.7 1 / 12,466 17 / 12,49494.1%
(62.4, 99.9)94.1%
(62.4, 99.9)
Mid Season 2
Post dose 114 4 / 12,469 33 / 12,49886.8%#
(63.0, 96.6)84.6%¶
(56.4, 96.1)
Season 2 Only
Post dose 26.4 5 / 4,991 28 / 10,03164.2%
(6.2, 89.2)64.2%
(6.2, 89.2)
Season 1 + 2** 18 7 / 12,469 48 / 12,49882.7%#
(61.6, 93.4)78.8%¶
(52.6, 92.0)
Annual (2 doses, ~12 months apart)
Season 2 Only
Post dose 26.4 5 / 4,966 28 / 10,03164.1%
(5.9, 89.2)64.1%
(5.9, 89.2)
Seasons 1 + 2** 18 7/12,469 48/ 12,49882.7%#
(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 PlaceboVE
(95% CI)VE
(95% CI) Number of events
Season 1*
(Median follow -up = 6.7 months)
≥ 1 pre -existing
comorbidity of interest1 / 4,937 18 / 4,86194.6%
(65.9, 99.9)94.6%
(65.9, 99.9)
Pre-frail 1 / 4,792 14 / 4,77892.9%
(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 interest16 / 4,983 72 / 4,91974.5%#
(55.7, 86.1)66.7%¶
(41.8, 82.0)
Pre-frail 8 / 4,794 47 / 4,77980.0%#
(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 metabo liccondition
*April 2022 analysis; †From 15 days post Dose 1 up to end of Season 2 in Northern HemisphereAReSVi -006
Presentation by GSK at ACIP June 21, 2023
CO-9
AREXVY PlaceboVE
(95% CI)VE
(95% CI) Number of events
Season 1*
(Median follow -up = 6.7 months)
≥ 60 YOA*** 7 / 12,466 40 / 12,49482.6%
(57.9, 94.1)82.6%
(57.9, 94.1)
60 –69 YOA 4 / 6,963 21 / 6,97981.0%
(43.6, 95.3)81.0%
(43.6, 95.3)
70 –79 YOA 1 / 4,487 16 / 4,48793.8%
(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/ 12,49874.5%#
(60.0, 84.5) 67.2%¶
(48.2, 80.0)
60 –69 YOA 17/ 6,963 74/ 6,98172.9%#
(53.7, 85.0)65.4%¶
(40.4, 80.9)
70 –79 YOA 9 / 4,489 55/ 4,48980.7%#
(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 HemisphereAReSVi -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 HemisphereAReSVi -006
Presentation by GSK at ACIP June 21, 2023AREXVY PlaceboVE
(95% CI)VE
(95% CI) Number of events
Season 1*
(Median follow -up = 6.7 months)
RSV-A 2/ 12,466 13/ 12,49484.6%
(32.1, 98.3)84.6%
(32.1, 98.3)
RSV-B 5/ 12,466 26/ 12,49480.9%
(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/ 12,49885.2%#
(65.4, 94.8)80.5%¶
(54.0, 93.2)
RSV-B 24/ 12,469 90/ 12,49868.5%#
(50.2, 80.8)59.7%¶
(35.8, 75.5)
0 20 40 60 80 100
CO-11
Reactogenicity Profile of 2ndDose in Line with 1stDose
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, 2023Local Systemic8.1
1.19.8
0.9 0.160.9
9.352.1
9.0 7.66.0
0.87.1
0.3 0.318.0
6.416.9
5.8 7.233.7
16.130.1
12.8 12.0
2.00.31.80.3 0.627.2
12.622.1
12.29.029.0
8.225.2
5.87.8
020406080100
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 MyalgiaAREXVY
AREXVY
AREXVY
AREXVY
AREXVY
AREXVY
AREXVY
AREXVY2 doses AREXVY
(1st& 2ndseason)1 dose AREXVY (1stseason)
/ Placebo (2ndseason)Placebo
(1st& 2nd season)1 dose AREXVY
(1stseason)Season 22 doses
2 doses
2 doses
2 doses
2 doses
2 doses
2 doses
2 doses% of
Participants
CO-12
Safety Profile of 2ndDose in Line with 1stDose
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 d oseSeason 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 diseaseAReSVi -006
Presentation by GSK at ACIP June 21, 2023Unsolicited AEs
Within 30 daysSAEs
Up to 6 months post
vaccinationUp to DLP (Season 2)pIMDs Fatal SAEs33.0
17.828.5
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
020406080100
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 1.2Grade 32 doses AREXVY
(1st& 2ndseason)1 dose AREXVY (1stseason)
/ Placebo (2ndseason)Placebo
(1st& 2nd season)1 dose AREXVY
(1stseason)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 vacci ne 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 61R
Control
(AREXVY)
Co-Ad
Control
Co-Ad
Safety Monitoring
through 6 monthsBlood 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
AntibodyCo-Ad
NControl
NGMT Ratio (Control Over Co -Administration)
1 Month After Vaccination
Per Protocol SetGMT Ratio
(95% CI)
Flu A/Darwin H3N2 458 4410.98
(0.84, 1.14)
Flu A/Victoria H1N1 452 4350.93
(0.80, 1.08)
Flu B/Austria/Victoria 458 4410.95
(0.88, 1.03)
Flu B/Phuket/Yamagata 456 4410.92
(0.84, 1.02)
RSV-A* 459 3581.18
(1.04, 1.35)
RSV-B 459 3571.02
(0.89, 1.16)
0.5 1 1.5
Presentation by GSK at ACIP June 21, 2023Success 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, 2023Success 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 strainsAntibodyCo-Ad
NControl
NGMT Ratio (Control Over Co -Administration)
1 Month After Vaccination
Per Protocol SetGMT Ratio
(95% CI)
Flu A/Darwin H3N2* 433 4021.31
(1.13, 1.52)
Flu A/Victoria H1N1 424 3981.03
(0.91, 1.18)
Flu B/Austria/Victoria 433 4020.97
(0.89, 1.05)
Flu B/Phuket/Yamagata 432 4021.04
(0.95, 1.12)
RSV-A** 475 3770.98
(0.87, 1.11)
RSV-B 473 3771.16
(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 activity4.0% 4.6%47.0%
42.5%
4.5% 5.6%
0% 0%1.2% 0.5%
0% 0.2%
020406080100
Co-Ad
Visit 1FLU
Visit 1Co-Ad
Visit 1FLU
Visit 1Co-Ad
Visit 1FLU
Visit 1FLU-QIV-HD
Erythema SwellingPain
4.3% 4.3%55.6%
46.3%
4.0% 4.3%
0.2% 0.3%2.1%0.3%0% 0.3%020406080100
Co-Ad
Visit 1AREXVY
Visit 2Co-Ad
Visit 1AREXVY
Visit 2Co-Ad
Visit 1AREXVY
Visit 2AREXVY
Erythema Swelling
% of
ParticipantsPainRSV OA=ADJ -008: FLU QIV -HD
Presentation by GSK at ACIP June 21, 2023Co-Ad Grade 3 FLU AREXVY
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%020406080100
Co-Ad
Visit 1FLU
Visit 1Co-Ad
Visit 1FLU
Visit 1Co-Ad
Visit 1FLU
Visit 1FLU-aQIV
Erythema Swelling Pain
11.8%9.5%65.9%
58.8%
8.7%6.0%
1.9% 1.3%0.6% 0.2%1.0% 0.7%020406080100
Co-Ad
Visit 1AREXVY
Visit 2Co-Ad
Visit 1AREXVY
Visit 2Co-Ad
Visit 1AREXVY
Visit 2AREXVY
Erythema Swelling
% of
ParticipantsPainRSV 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, 2023Co-Ad Grade 3 FLU AREXVY
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 activityRSV OA=ADJ -008: FLU QIV -HD
Presentation by GSK at ACIP June 21, 202316.1%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%
020406080100
Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Arthralgia Fatigue Fever Headache MyalgiaSolicited Systemic Adverse Events
% of
ParticipantsCo-Ad Grade 3 FLU AREXVY
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 activityRSV OA=ADJ -017: FLU aQIV
Presentation by GSK at ACIP June 21, 202325.8%
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%
020406080100
Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2Co-Ad
Visit 1FLU
Visit 1AREXVY
Visit 2% of
ParticipantsArthralgia Fatigue Fever Headache MyalgiaSolicited Systemic Adverse EventsCo-Ad Grade 3 FLU AREXVY
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 2nddose in line with 1stdose; 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 studyR
Study initiated Feb 2021
QA-23
Immunogenicity Overview Through Month 18 Post Vaccination
RSV-B Serum Neutralization Titers
RSV-A Serum Neutralization Titers
RSVPreF3 -specific CD4+ T -cells
Timepoint (days)
RSVPreF 3 CD4+ T -cells, /106cells (GM) GMT (ED60)
GMT (ED60)
Timepoint (days) Timepoint (days)020004000600080001000012000
0 200 400 600**~10X
**~3X~6X
020004000600080001000012000
0 200 400 600**~8.X
**~2.4X**~4X
05001000150020002500
0 200 400 6001 dose 2 doses 1 dose 2 doses 1 dose 2 doses
M6 M12 M18 D0 M6 M12 M18 D0 M6 M12 M18 D0**”~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 factorAReSVi -004
*RSV -A preliminary, final results pending