Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Condition(s) studied
Investigational drug(s) / intervention(s)
RSVPreF3 OA investigational vaccine: RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Study summary
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Eligibility
Primary outcome measure(s)
- Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 — At Day 1
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). - Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31 — At Day 31
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. - Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6 — At Month 6
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. - Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12 — At Month 12
RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. - Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1 — At Day 1
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. - Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31 — At Day 31
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. - Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6 — At Month 6
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. - Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12 — At Month 12
RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | |
| GSK Investigational Site | Phoenix | Arizona | |
| GSK Investigational Site | Riverside | California | |
| GSK Investigational Site | San Diego | California | |
| GSK Investigational Site | Coral Gables | Florida | |
| GSK Investigational Site | Fort Myers | Florida | |
| GSK Investigational Site | Sarasota | Florida | |
| GSK Investigational Site | The Villages | Florida | |
| GSK Investigational Site | Evansville | Indiana | |
| GSK Investigational Site | Wichita | Kansas | |
| GSK Investigational Site | Richfield | Minnesota | |
| GSK Investigational Site | Kansas City | Missouri | |
| GSK Investigational Site | Rochester | New York | |
| GSK Investigational Site | Mt. Pleasant | South Carolina | |
| GSK Investigational Site | Spartanburg | South Carolina | |
| GSK Investigational Site | San Antonio | Texas | |
| GSK Investigational Site | Norfolk | Virginia | |
| GSK Investigational Site | Wenatchee | Washington | |
| GSK Investigational Site | Pori | Satakunta | |
| GSK Investigational Site | Espoo | Finland | |
| GSK Investigational Site | Helsinki | Finland | |
| GSK Investigational Site | Helsinki | Finland | |
| GSK Investigational Site | Jarvenpaa | Finland | |
| GSK Investigational Site | Kokkola | Finland | |
| GSK Investigational Site | Oulu | Finland | |
| GSK Investigational Site | Seinäjoki | Finland | |
| GSK Investigational Site | Tampere | Finland | |
| GSK Investigational Site | Turku | Finland | |
| GSK Investigational Site | Essen | North Rhine-Westphalia | |
| GSK Investigational Site | Goch | North Rhine-Westphalia | |
| GSK Investigational Site | Essen | Germany | |
| GSK Investigational Site | Hamburg | Germany | |
| GSK Investigational Site | Mainz | Germany | |
| GSK Investigational Site | München | Germany | |
| GSK Investigational Site | Wallerfing | Germany | |
| GSK Investigational Site | Würzburg | Germany | |
| GSK Investigational Site | Fukuoka | Japan | |
| GSK Investigational Site | Kumamoto | Japan | |
| GSK Investigational Site | Tokyo | Japan | |
| GSK Investigational Site | Changhua | Taiwan |
+ 6 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in Japan
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 NCT04732871 on ClinicalTrials.gov ↗ ← All trials in Japan