The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
10,212
RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1
Time frame: At Day 1
RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31
Time frame: At Day 31
RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1
Time frame: At Day 1
RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31
Time frame: At Day 31
RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group
Time frame: From Day 1 to Day 31
RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group
Time frame: From Day 1 to Day 31
Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group at Day 1
Time frame: At Day 1
Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_PreS4 group at Day 31
Time frame: At Day 31
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 1
Time frame: At Day 1
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 31
Time frame: At Day 31
Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS4 group
Time frame: At Day 31
Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS4 group
Time frame: At Day 31
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Day 1
Time frame: At Day 1
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 12
Time frame: At Month 12
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 13
Time frame: At Month 13
RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 24
Time frame: At Month 24
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Day 1
Time frame: At Day 1
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 12
Time frame: At Month 12
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 13
Time frame: At Month 13
RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 24
Time frame: At Month 24
RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13
Time frame: From Month 12 to Month 13
RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24
Time frame: From Month 12 to Month 24
RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13
Time frame: From Month 12 to Month 13
RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24
Time frame: From Month 12 to Month 24
Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Day 1
Time frame: At Day 1
Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 12
Time frame: At Month 12
Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 13
Time frame: At Month 13
Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 24
Time frame: At Month 24
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Day 1
Time frame: At Day 1
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 12
Time frame: At Month 12
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 13
Time frame: At Month 13
Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 24
Time frame: At Month 24
Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS5 group
Time frame: At Month 13
Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS5 group
Time frame: At Month 13
RSV-A neutralizing titers expressed as GMTs in RSV_1Dose group
Time frame: At Day 1, Month 12 and at Month 24
RSV-B neutralizing titers expressed as GMTs in RSV_1Dose group
Time frame: At Day 1, Month 12 and at Month 24
Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_1Dose group
Time frame: At Day 1, Month 12 and at Month 24
Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV_1Dose group
Time frame: At Day 1, Month 12 and at Month 24
Number of participants with unsolicited adverse events
Time frame: At Day 30 post vaccination
Number of participants with any serious adverse events (SAEs)
Time frame: From day of vaccination and up to 6 months post each vaccine administration
Number of participants with SAEs related to study intervention
Time frame: From Day 1 and up to end of study
Number of participants with any potential immune-mediated disease (pIMDs)
Time frame: From day of vaccination and up to 6 months post each vaccine administration
Number of participants with pIMDs related to study intervention
Time frame: From Day 1 and up to end of study
Number of participants with fatal SAEs
Time frame: From Day 1 and up to end of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Cerritos, California, United States
GSK Investigational Site
Doral, Florida, United States
GSK Investigational Site
Fort Myers, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Lake City, Florida, United States
...and 240 more locations