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 Italy
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 Italy