Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory syncytial virus (RSV), Older adults, RSVPreF3 OA vaccine, Immunogenicity, Safety, RSV Season
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 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.
Interventions
BIOLOGICALRSVPreF3 OA vaccine
RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is an extension and crossover study.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| RSV-A neutralizing titers expressed as GMTs in RSV_1Dose group | At Day 1, Month 12 and at Month 24 |
| RSV-B neutralizing titers expressed as GMTs in RSV_1Dose group | At Day 1, Month 12 and at Month 24 |
| Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_1Dose group | At Day 1, Month 12 and at Month 24 |
| Percentage of participants with RSV-B neutralizing titers >= cut-off in RSV_1Dose group | At Day 1, Month 12 and at Month 24 |
| Number of participants with unsolicited adverse events | At Day 30 post vaccination |
| Number of participants with any serious adverse events (SAEs) | From day of vaccination and up to 6 months post each vaccine administration |
| Number of participants with SAEs related to study intervention | From Day 1 and up to end of study |
| Number of participants with any potential immune-mediated disease (pIMDs) | From day of vaccination and up to 6 months post each vaccine administration |
| Number of participants with pIMDs related to study intervention | From Day 1 and up to end of study |
| Number of participants with fatal SAEs | From Day 1 and up to end of study |
Countries
Australia, Belgium, Canada, Estonia, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Outcome results
None listed