The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,029
RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).
RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
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)
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
HI titers were assessed 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 strains.
Time frame: At 1 month after the FLU vaccine dose (Day 31 for both groups)
RSV-B Neutralizing Titers Expressed as Group GMTs
RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
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)
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
SCR for HI titers was 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 Neutralizing 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
Birmingham, Alabama, United States
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Tempe, Arizona, United States
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Colton, California, United States
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RSV-B Neutralizing 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)
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
HI titers were assessed 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 strains. HI antibodies were expressed as GMTs, in titers.
Time frame: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
SPR for HI titers was defined as the percentage of participants with a serum HI titer \>= 1:40. The assessed Flu strains were: 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 and 1 month after FLU vaccine dose administration (Day 31 for both groups)
HI 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.
Time frame: At 1 month after the FLU vaccine dose administration (Day 31 for both groups)
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
The solicited administration site events after vaccination included erythema, pain and swelling.
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia.
Time frame: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)
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 diary. Unsolicited events must have been 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 after vaccine administration (the day of vaccination and 29 subsequent days after vaccination)
Percentage of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Time frame: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)
Percentage of Participants Reporting 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 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)