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Co-administration with Influenza Vaccines

Co-administration of RSVPreF3 OA vaccine with influenza vaccines was evaluated in three Phase 3, randomized, controlled, open-label studies. These studies evaluated the non-inferiority of the immune response to each of the co-administered vaccines, compared with sequential administration of each vaccine 1 month apart:

  • Study 007: Co-administration with quadrivalent influenza vaccine (FLU-QIV)1
  • Study 008: Co-administration with high-dose quadrivalent influenza vaccine (FLU-QIV-HD)2
  • Study 017: Co-administration with adjuvanted quadrivalent influenza vaccine (FLU-aQIV)3

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Study Design

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Study Results: Study 007

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Study Results: Study 008

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Study Results: Study 017

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Study Design4

study-design-for-3-studies-evaluating-co-administration-of-influenza-vaccines-with-the-r-s-v-pre-f-3-o-a-vaccine-compared-to-sequential-administration-of-each-vaccine-alone-in-older-adults-60-or-65-years-of-age-or-older.-participants-were-randomized-1-to-1-to-control-or-coadministration-group.-in-the-control-group,-participants-received-a-flu-vaccine-on-day-1,-and-a-r-s-v-pre-f-3-o-a-vaccine-on-day-31.-blood-samples-were-collected-on-days-1,-31-and-61.-in-the-coadministration-group,-participants-received-a-flu-vaccine-and-r-s-v-pre-f-3-o-a-vaccine-on-day-1.-blood-samples-were-taken-on-days-1-and-31.-all-participants-were-followed-until-month-6-for-safety-monitoring.-study-007-investigated-the-flu-vaccine-flu-q-i-v-in-adults-60-years-of-age-or-older.-study-008-investigated-high-dose-flu-q-i-v-in-adults-65-years-or-older.-study-017-investigated-adjuvanted-flu-q-i-v-in-adults-aged-65-years-or-older.

Figure adapted with permission from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023

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Co-primary objectives1–4:

Non-inferiority* (1 month post-vaccination) of co-administration versus administration of each vaccine alone for:

  • RSVPreF3 OA in terms of:
    • RSV-A neutralizing antibody (NAb) geometric mean titer (GMT) ratio
    • RSV-B NAb GMT ratio (for Studies 008 and 017 only)
  • Influenza vaccine in terms of hemagglutinin inhibition (HI) Ab GMT ratio for each flu strain†

*To demonstrate non-inferiority: upper limit (UL) of the 95% CI of the group GMT ratio (control/co-administration) ≤1.5; †Flu A/H3N2, Flu A/H1N1, Flu B/Yamagata, and Flu B/Victoria

Secondary objectives:1–3

  • Reactogenicity and safety
  • Secondary humoral immunogenicity

Secondary humoral immunogenicity1

  • Solicited events up to 4 days post-vaccination (7 days for Study 017)
  • Unsolicited adverse events (AEs) up to 30 days post-vaccination
  • All serious adverse events (SAEs) and potential immune-mediated diseases (pIMDs) up to study end

Study Results: Study 007

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Co-primary objectives:1

Co-primary endpoints were met for both FLU-QIV and RSVPreF3 OA; non-inferior immunogenicity of FLU-QIV and RSVPreF3 OA co-administration versus administration of each vaccine alone5,6

Ratio of RSV NAb GMTs and HI GMTs between the control group (sequential administration) and the co-administration group, 1 month after vaccination5,6

forest-plot-showing-r-s-v-neutralizing-antibodies-and-influenza-hemagglutinin-inhibition-antibody-geometric-mean-titer-ratios-for-control-versus-co-administration-in-the-007-study.-the-non-inferiority-success-criteria-were-met-if-the-upper-limit-of-the-95-percent-confidence-interval-was-less-than-or-equal-to-1.5-for-the-geometric-mean-titer-ratio-of-control-divided-by-co-administration.

Figure adapted with permission from Chandler R et al. Immunogenicity, reactogenicity and safety of a respiratory syncytial virus prefusion F (RSVPreF3) candidate vaccine co-administered with the seasonal quadrivalent vaccine in older adults. Presented at IDWeek; October 19−23, 2022, Washington, DC, USA

*RSV-B NAb was a descriptive and secondary endpoint

Solicited local and systemic AEs:5

Results showed that the RSVPreF3 OA vaccine has an overall clinically acceptable safety profile when co-administered with FLU-QIV.5

The most frequently reported solicited administration-site event was pain.5 The most frequently reported systemic events were fatigue, headache, and myalgia.5

Percentage of participants with solicited AEs within 4 days – exposed set Co-Ad (RSVPreF3 OA + FLU-QIV at Visit 1) or Control (RSVPreF3 OA at Visit 2)

column-graph-showing-the-percentage-of-participants-in-the-co-administration-and-the-control-groups-of-the-007-study-that-experienced-solicited-local-adverse-events,-including-erythema,-pain,-and-swelling.
column-graph-showing-the-percentage-of-participants-in-the-co-administration-and-the-control-groups-in-the-007-study-that-experienced-the-systemic-solicited-adverse-events-of-arthralgia,-fatigue,-fever,-headache,-and-myalgia.

Figures adapted with permission from Chandler R et al. Immunogenicity, reactogenicity and safety of a respiratory syncytial virus prefusion F (RSVPreF3) candidate vaccine co-administered with the seasonal quadrivalent vaccine in older adults. Presented at IDWeek; October 19−23, 2022, Washington, DC, USA

Co-Ad group: participants receiving a single dose of RSVPreF3 OA vaccine and a single dose of FLU-QIV vaccine at Visit 1 (Day 1); data post-RSVPreF3 OA dose for local AEs; Control group: participants receiving a single dose of FLU-QIV vaccine at Visit 1 (Day 1), followed by a single dose of the RSVPreF3 OA vaccine at Visit 2 (Day 31); data post-dose 2 (RSVPreF3 OA vaccine)

Grade 3 erythema and swelling: >100 mm; Grade 3 pain: defined as significant pain at rest, prevents normal everyday activities; 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; Grade 3 headache, fatigue, myalgia, arthralgia defined as preventing normal activity

Study Results: Study 008

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Co-primary objectives4:

Co-primary endpoints were met for both FLU-QIV-HD and RSVPreF3 OA: non-inferior immunogenicity of FLU-QIV-HD and RSVPreF3 OA co-administration versus administration of each vaccine alone4

Ratio of RSV NAb GMTs and HI GMTs between the control group (sequential administration) and the co-administration group, 1 month after vaccination4

forest-plot-showing-r-s-v-neutralizing-antibodies-and-influenza-hemagglutinin-inhibition-antibody-geometric-mean-titer-ratios-for-control-versus-coadministration-in-the-008-study.-the-non-inferiority-success-criteria-were-met-if-the-upper-limit-of-the-95-percent-confidence-interval-was-less-than-or-equal-to-1.5-for-the-geometric-mean-titer-ratio-of-control-divided-by-co-administration.-non-inferior-immunogenicity-was-demonstrated-for-co-administration-of-high-dose-quadrivalent-influenza-vaccine-with-r-s-v-pre-f-3-o-a-versus-control.

Figure adapted with permission from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023

*RSV-A preliminary, final results pending

Solicited local and systemic AEs:4

Results showed that the RSVPreF3 OA vaccine has an overall clinically acceptable safety profile when co-administered with FLU-QIV-HD.4

The most frequently reported solicited administration-site event was pain.4 The most frequently reported systemic events were fatigue, headache, and myalgia.4

Percentage of participants with solicited AEs within 4 days – modified set

column-graph-showing-the-percentage-of-participants-that-experienced-solicited-local-adverse-events,-including-erythema,-pain-and-swelling-in-the-co-administrationgroup-and-the-control-group-following-high-dose-quadrivalent-influenza-vaccine-in-the-008-study.
column-graph-showing-the-percentage-of-participants-that-experienced-solicited-systemic-adverse-events,-including-arthralgia,-fatigue,-fever,-headache-and-myalgia-in-the-co-administration-group-and-the-control-group-following-high-dose-quadrivalent-influenza-vaccine-or-r-s-v-pre-f-3-o-a-vaccine-in-the-008-study.

Figure adapted with permission from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023

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

Study Results: Study 017

Co-primary objectives4:

Non-inferior criteria were met for 3 of 4 flu strains and for RSV-A when FLU-aQIV and RSVPreF3 OA were co-administered versus administration of each vaccine alone. Neutralizing titers were comparable for RSV-B4

Ratio of RSV NAb GMTs and HI GMTs between the control group (sequential administration) and the co-administration group, 1 month after vaccination4

forest-plot-showing-r-s-v-neutralizing-antibodies-and-influenza-hemagglutinin-inhibition-antibody-geometric-mean-titer-ratios-for-control-versus-coadministration-in-the-017-study.-the-non-inferiority-success-criteria-were-met-if-the-upper-limit-of-the-95-percent-confidence-interval-of-less-than-or-equal-to-1.5-for-the-geometric-mean-titer-ratio-of-control-divided-by-co-administration.-non-inferior-criteria-were-met-for-3-of-4-flu-strains-and-for-r-s-v-a-when-adjuvanted-quadrivalent-influenza-vaccine-and-r-s-v-pre-f-3-o-a-were-co-administered-versus-administration-of-each-vaccine-alone.-neutralizing-titers-were-comparable-for-r-s-v-b.

Figure adapted with permission from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023

*Non-inferiority criterion was marginally missed. Lower HI titers observed than expected, investigation ongoing; †RSV-A preliminary, final results pending

Solicited local and systemic AEs4:

Results showed that the RSVPreF3 OA vaccine has an overall clinically acceptable safety profile when co-administered with FLU-aQIV.4 The most frequently reported solicited administration-site event was pain.4 The most frequently reported systemic events were fatigue, headache, and myalgia.4

Percentage of participants with solicited AEs within 7 days – exposed set

column-graph-showing-the-percentage-of-participants-that-experienced-solicited-local-adverse-events,-including-erythema,-pain-and-swelling-in-the-co-administration-group-and-the-control-group-following-adjuvanted-quadrivalent-influenza-vaccine-in-the-017-study.
column-graph-showing-the-percentage-of-participants-that-experienced-solicited-systemic-adverse-events,-including-arthralgia,-fatigue,-fever,-headache-and-myalgia-in-the-co-administration-group-and-the-control-group-following-adjuvanted-quadrivalent-influenza-vaccine-or-r-s-v-pre-f-3-o-a-vaccine-in-the-017-study.

Figures adapted with permission from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023

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

Click on a section below to learn more:

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RSVPreF3 OA Overview

Click here for an overview of the RSVPreF3 OA vaccine

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Pivotal Efficacy and Safety in ≥60 YOA

Click here to learn about RSVPreF3 OA vaccine's pivotal efficacy and safety results

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Abbreviations

Ab, antibody; AE, adverse event; CI, confidence interval; Co-Ad, co-administration; FLU-aQIV, adjuvanted quadrivalent influenza vaccine; FLU-QIV, seasonal quadrivalent influenza vaccine; FLU-QIV-HD, high-dose quadrivalent influenza vaccine; GMT, geometric mean titer; HI, hemagglutinin inhibition; NAb, neutralizing antibody; pIMD, potential immune-mediated disease; R, randomization; RSV, respiratory syncytial virus; SAE, serious adverse event; UL, upper limit; YOA, years of age.

References

  1. ClinicalTrials.gov. NCT04841577. https://clinicaltrials.gov/study/NCT04841577. Accessed August 2023.
  2. ClinicalTrials.gov. NCT05559476. https://clinicaltrials.gov/study/NCT05559476. Accessed August 2023.
  3. ClinicalTrials.gov. NCT05568797. https://clinicaltrials.gov/study/NCT05568797. Accessed August 2023.
  4. Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presentation at Advisory Committee in Immunization Practices (ACIP) Meeting, June 21, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/03-RSV-Adults-Friedland-508.pdf. Accessed August 2023.
  5. Chandler R et al. Immunogenicity, reactogenicity and safety of a respiratory syncytial virus prefusion F (RSVPreF3) candidate vaccine co-administered with the seasonal quadrivalent influenza vaccine in older adults. Presented at IDWeek; October 19−23, 2022, Washington, DC, USA.
  6. Rizkalla B. GSK RSV OA candidate vaccine clinical development. Presentation at Advisory Committee on Immunization Practices (ACIP) Meeting, October 20, 2022. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-10-19-20/02-RSV-Adults-Rizkalla-508.pdf Accessed August 2023.

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©2023 GSK group of companies or its licensor. GlaxoSmithKline Biologicals SA. Rixensart, Belgium.

NX-GBL-RSA-WCNT-230003 | August 2023