Study Design
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
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
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
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)
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
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
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
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
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
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
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
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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
- ClinicalTrials.gov. NCT04841577. https://clinicaltrials.gov/study/NCT04841577. Accessed August 2023.
- ClinicalTrials.gov. NCT05559476. https://clinicaltrials.gov/study/NCT05559476. Accessed August 2023.
- ClinicalTrials.gov. NCT05568797. https://clinicaltrials.gov/study/NCT05568797. Accessed August 2023.
- 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.
- 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.
- 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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NX-NL-RSA-WCNT-250007 | October 2025