An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
Condition(s) studied
Investigational drug(s) / intervention(s)
RSVPreF3 OA vaccine: RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)
Study summary
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.
Eligibility
Primary outcome measure(s)
- RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1 — At Day 1
- RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31 — At Day 31
- RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1 — At Day 1
- RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31 — At Day 31
- RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group — From Day 1 to Day 31
- RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group — 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 — At Day 1
- Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_PreS4 group at Day 31 — At Day 31
- Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 1 — At Day 1
- Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS4 group at Day 31 — At Day 31
- Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS4 group — At Day 31
- Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS4 group — At Day 31
- RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Day 1 — At Day 1
- RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 12 — At Month 12
- RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 13 — At Month 13
- RSV-A neutralizing titers expressed as GMT in RSV_PreS5 group at Month 24 — At Month 24
- RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Day 1 — At Day 1
- RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 12 — At Month 12
- RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 13 — At Month 13
- RSV-B neutralizing titers expressed as GMTs in RSV_PreS5 group at Month 24 — At Month 24
- RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13 — From Month 12 to Month 13
- RSV-A neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24 — From Month 12 to Month 24
- RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 13 — From Month 12 to Month 13
- RSV-B neutralizing titers expressed as MGI in RSV_PreS5 group from Month 12 to Month 24 — From Month 12 to Month 24
- Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Day 1 — At Day 1
- Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 12 — At Month 12
- Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 13 — At Month 13
- Percentage of participants with RSV-A neutralizing titers >=cut-off in RSV_PreS5 group at Month 24 — At Month 24
- Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Day 1 — At Day 1
- Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 12 — At Month 12
- Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 13 — At Month 13
- Percentage of participants with RSV-B neutralizing titers >=cut-off in RSV_PreS5 group at Month 24 — At Month 24
- Percentage of participants with seroresponse rate (SRR) for RSV-A neutralizing titers in RSV_PreS5 group — At Month 13
- Percentage of participants with SRR for RSV-B neutralizing titers in RSV_PreS5 group — At Month 13
Trial sites (251)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | |
| GSK Investigational Site | Birmingham | Alabama | |
| GSK Investigational Site | Huntsville | Alabama | |
| GSK Investigational Site | Phoenix | Arizona | |
| GSK Investigational Site | Tucson | Arizona | |
| GSK Investigational Site | Cerritos | California | |
| GSK Investigational Site | Doral | Florida | |
| GSK Investigational Site | Fort Myers | Florida | |
| GSK Investigational Site | Jacksonville | Florida | |
| GSK Investigational Site | Lake City | Florida | |
| GSK Investigational Site | Melbourne | Florida | |
| GSK Investigational Site | Miami | Florida | |
| GSK Investigational Site | Orlando | Florida | |
| GSK Investigational Site | Pinellas Park | Florida | |
| GSK Investigational Site | The Villages | Florida | |
| GSK Investigational Site | West Palm Beach | Florida | |
| GSK Investigational Site | Atlanta | Georgia | |
| GSK Investigational Site | Savannah | Georgia | |
| GSK Investigational Site | Chicago | Illinois | |
| GSK Investigational Site | Evansville | Indiana | |
| GSK Investigational Site | Mishawaka | Indiana | |
| GSK Investigational Site | El Dorado | Kansas | |
| GSK Investigational Site | Newton | Kansas | |
| GSK Investigational Site | Wichita | Kansas | |
| GSK Investigational Site | Wichita | Kansas | |
| GSK Investigational Site | Lexington | Kentucky | |
| GSK Investigational Site | Rockville | Maryland | |
| GSK Investigational Site | Richfield | Minnesota | |
| GSK Investigational Site | Kansas City | Missouri | |
| GSK Investigational Site | St Louis | Missouri | |
| GSK Investigational Site | Omaha | Nebraska | |
| GSK Investigational Site | Las Vegas | Nevada | |
| GSK Investigational Site | New York | New York | |
| GSK Investigational Site | Rochester | New York | |
| GSK Investigational Site | Hickory | North Carolina | |
| GSK Investigational Site | Mooresville | North Carolina | |
| GSK Investigational Site | Rocky Mount | North Carolina | |
| GSK Investigational Site | Salisbury | North Carolina | |
| GSK Investigational Site | Winston-Salem | North Carolina | |
| GSK Investigational Site | Centerville | Ohio |
+ 211 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06534892 on ClinicalTrials.gov ↗ ← All trials in South Korea