The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,045
One dose of RSVPreF3 OA vaccine administered intramuscularly.
One dose of FLU vaccine administered intramuscularly.
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains.
Time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
RSV-A Neutralizing Antibody Titers Expressed as GMTs
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60).
Time frame: At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
RSV-B Neutralizing Antibody Titers Expressed as GMTs
RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60).
Time frame: At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group)
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
SCR for HI antibody is defined as the percentage of participants who have either a HI predose titer less than (\<) 1:10 and a post-dose titer greater than or equal to (\>=) 1:40, or a pre-dose titer \>= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
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GSK Investigational Site
Edegem, Belgium
GSK Investigational Site
Erpent, Belgium
GSK Investigational Site
Genk, Belgium
GSK Investigational Site
Ieper, Belgium
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
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Kokkola, Finland
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Oulu, Finland
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Seinäjoki, Finland
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Tampere, Finland
...and 27 more locations
RSV-B Neutralization Antibody Titers Expressed as MGI
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
Titers for HI Antibodies Against 4 FLU Vaccine Strains
HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. HI antibodies were expressed as GMT, in titers.
Time frame: At Day 1 (Baseline) and Day 31
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
SPR for HI antibody was defined as the percentage of participants with a serum HI titer \>= 1:40. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Time frame: At Day 1 (Baseline) and Day 31
HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Time frame: At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups)
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
The solicited administration site events after vaccination include erythema, pain and swelling.
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group)
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group)
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
An unsolicited AEs is an AE that is not included in a list of solicited events using a Participant Electronic Diary. Unsolicited events must be spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs).
Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration
Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant.
Time frame: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs)
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e., pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD.
Time frame: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)