RSV Vaccine for Adults 60+
(RSV OA=ADJ=012 Trial)
Trial Summary
Do I need to stop my current medications for the RSV vaccine trial?
The trial does not specify that you need to stop taking your current medications. However, if you are on immunosuppressants or immune-modifying drugs, you may need to stop them 90 days before the study starts. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the RSVPreF3 OA vaccine, Arexvy, for adults 60+?
Research shows that the RSVPreF3 OA vaccine is effective in older adults, especially those with existing health conditions, in preventing severe respiratory illnesses caused by RSV. The vaccine has been shown to boost the body's immune response, making it a promising option for protecting older adults from RSV-related diseases.12345
Is the RSVPreF3 OA vaccine safe for adults aged 60 and over?
How is the RSVPreF3 OA vaccine different from other drugs for RSV in adults 60+?
The RSVPreF3 OA vaccine is unique because it specifically targets the respiratory syncytial virus (RSV) in adults aged 60 and older, a group for which there are limited existing vaccines. This vaccine is designed to boost the immune system's response to RSV, potentially offering better protection for older adults who are more vulnerable to severe RSV infections.910111213
What is the purpose of this trial?
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 Criteria
This trial is for adults aged 60 and above who previously took part in the RSV OA=ADJ-006 study. It's designed to assess the timing for a second vaccine dose, long-term safety, and immune response over approximately five RSV seasons.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Revaccination
Participants receive a dose of RSVPreF3 OA vaccine before RSV Season 4 or 5, or a single dose in the crossover group
Long-term Follow-up
Participants are monitored for immune persistence and safety up to 5 consecutive RSV seasons
Treatment Details
Interventions
- RSVPreF3 OA vaccine
RSVPreF3 OA vaccine is already approved in United States for the following indications:
- Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School