To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged \>=50 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
530
One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.
Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination
Anti-gE antibodies were measured with enzyme linked immunosorbent assay (ELISA) and the results were expressed as GMC, in milli international units per milliliter (mIU/mL).
Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91)
Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Time frame: At Day 31 for Co-administration Group and at Day 61 for Control Group
Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Seropositivity was defined as the percentage of participants whose antibody concentration was greater than or equal to the assay cut-off value (97 mIU/mL).
Time frame: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
Anti-gE antibodies were measured with ELISA and the results were expressed as GMC.
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GSK Investigational Site
Daphne, Alabama, United States
GSK Investigational Site
Tempe, Arizona, United States
GSK Investigational Site
Corte Madera, California, United States
GSK Investigational Site
Aurora, Colorado, United States
GSK Investigational Site
North Miami Beach, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Columbus, Georgia, United States
GSK Investigational Site
Versailles, Kentucky, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Fort Worth, Texas, United States
...and 21 more locations
Time frame: Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)
Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination
The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Anti-gE antibodies were measured with ELISA.
Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1)
Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination
The VRR was defined as the percentage of participants who had at least: a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the pre-vaccination anti-gE antibody concentration (for participants who were seropositive at pre-vaccination); or, a 4-fold increase post-vaccination anti-gE antibody concentration as compared to (over) the anti-gE antibody cut-off value for seropositivity (97 mIU/mL) (for participants who were seronegative at pre-vaccination).
Time frame: At 1 month post-second dose of HZ/su vaccination (Day 91)
GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Time frame: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
MGI of Respiratory Syncytial Virus-A Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
GMT of RSV-B Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination
Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.
Time frame: At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group
MGI of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
The MGI was defined as the geometric mean of the within participant ratios of the post-vaccination titer over the pre-vaccination titer. Neutralizing titers were measured with neutralization assay.
Time frame: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for Co-administration Group and Day 61 for Control Group) compared to Pre-vaccination (Day 1 for Co-administration Group and Control Group)
Percentage of Participants With Solicited Administration Site Adverse Events (AEs) After Each Vaccine Dose Administration
The solicited administration site events after vaccination included pain, erythema/redness, and swelling.
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Percentage of Participants With Solicited Systemic AEs After Each Vaccine Dose Administration
The solicited systemic events after vaccination included arthralgia, fatigue, fever (pyrexia), headache, myalgia, shivering/chills, and gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain).
Time frame: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Days 1 and 61 for Co-Administration Group and at Days 1, 31 and 61 for Control group)
Percentage of Participants With Unsolicited Adverse Events
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must had been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious and non-serious AEs.
Time frame: Within 30 days (the day of vaccination and 29 subsequent days) after vaccine administration
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time frame: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days
Percentage of Participants With Potential Immune-mediated Diseases (pIMDs)
The pIMD was a subset of adverse events of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From first dose of study vaccine administration (Day 1) up to 6 months after last dose of study vaccine administration, approximately 241 days