respiratory syncytial virus (RSV)-associated (subtypes A and B) disease RSV infection
Conditions
Interventions
Participants will receive a single dose of study intervention (either RSVPreF3
OA investigational vaccine or placebo) at Visit 1.
Study participants must be observed closely for at least 30 minutes a
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol Cohort1 • A male or female participant 50-59 YOA • Female participants migth be of childbearing potential.. • Female participants of childbearing potential may be enrolled in the study, if the participant: - has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and - has a negative pregnancy test on the day of study intervention administration. For participants in the Adults-HA (Healthy Adults) Sub-cohort: • Healthy participants as established by medical history and clinical examination before entering into the study. • Participants with chronic stable medical conditions with or without specific treatment For participants in the Adults-AIR (At increased Risk) Sub cohort: • Chronic pulmonary disease resulting in activity restricting symptoms or use of long term medication: - Chronic obstructive pulmonary disease (COPD); Grade 2-4 - Asthma - Cystic fibrosis - Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis • Chronic cardiovascular disease - Chronic heart failure (CHF) - Pre-existing coronary artery disease (CAD not otherwise specified) - Cardiac arrhythmia • Diabetes mellitus: types 1 and 2 • Other diseases at increased risk for RSV-LRTD disease - Chronic kidney disease - Chronic liver disease For participants in Cohort 2 (OA-RSV Group) • A male or female participant >=60 YOA • Participants with chronic stable medical conditions with or without specific treatment • Participants living in the general community or in an assisted-living facility that provides minimal assistance.
Exclusion criteria
Exclusion criteria: • Any confirmed or suspected immunosuppressive or immunodeficient condition • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. • Hypersensitivity to latex. • Unstable chronic illness. • Any history of dementia or any medical condition that moderately or severely impairs cognition. • Recurrent or uncontrolled neurological disorders or seizures. • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. • Use of any investigational or non-registered product, or planned use during the study period. • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines. • Previous vaccination with an RSV vaccine, including investigational RSV vaccines. • Chronic administration of immune-modifying drugs and/or administration of long-acting immune modifying treatments or planned administration at any time up to the end of the study. • Concurrently participating in another clinical study • History of chronic alcohol consumption and/or drug abuse • Pregnant or lactating female. • Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RSV-A neutralization titers expressed as group: - GMT ratio (OA-RSV/Adults-HA-RSV), 1 month after the RSVPreF3 OA investigational vaccine administration. - SRR difference (OA-RSV - Adults-HA-RSV), 1 month after the RSVPreF3 OA investigational vaccine administration compared to baseline RSV-B neutralization titers expressed as group: - GMT ratio (OA-RSV/Adults-HA-RSV), 1 month after the RSVPreF3 OA investigational vaccine administration. - SRR difference (OA-RSV - Adults-HA-RSV), 1 month after the RSVPreF3 OA investigational vaccine administration compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants reporting: - each solicited administration site event with onset within 4 days after study intervention administration - each solicited systemic event with onset within 4 days after study intervention administration - unsolicited AEs within 30 days after study intervention administration - any SAEs and pIMDs after study intervention administration up to Month 6. - SAEs and pIMDs related to study intervention administration after study intervention administration up to study end - any fatal SAEs after study intervention administration up to study end RSV-A and RSV-B neutralization titers expressed as GMT, at pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration. (sub study not conducted in the Netherlands) CMI response expressed as group geometric mean of the frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers, 1 month, 6 months and at 12 months after study intervention administration, in a subset of participants Tertiary: RSV-A and RSV-B neutralization titers expressed as GMT, at pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration, by baseline co-morbidities. Any further exploratory immunology such as but not limited to: - Antibodies against specific protein F epitopes or other RSV strains - Potential new immunological markers for protection - Frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing one or any combination of immune marker(s) | — |
Countries
Netherlands
Outcome results
None listed