Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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 conse...
Eligibility Criteria
Inclusion
- Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV\_1dose group).
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications).
- Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
- Participants who are medically stable in the opinion of the investigator at study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
Exclusion
- Medical Conditions:
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- Hypersensitivity to latex.
- Serious or unstable chronic illness.
- Recurrent or un-controlled neurological disorders or seizures.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures.
- Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions.
- Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination.
- Prior/Concomitant Therapy:
- • Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study.
- Prior/Concurrent Clinical Study Experience:
- • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Other
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
10212 Patients enrolled
Trial Details
Trial ID
NCT06534892
Start Date
August 1 2024
End Date
September 30 2026
Last Update
December 22 2025
Active Locations (250)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Birmingham, Alabama, United States, 35205
2
GSK Investigational Site
Birmingham, Alabama, United States, 35211
3
GSK Investigational Site
Huntsville, Alabama, United States, 35802
4
GSK Investigational Site
Phoenix, Arizona, United States, 85020