A Phase 3, observer-blind, randomized, placebo controlled study to evaluate the non inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults >=60 years of age.
- Conditions
- respiratory syncytial virus (RSV)-associated (subtypes A and B) diseaseRSV infection10024970
- Registration Number
- NL-OMON53679
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>RSV-A neutralization titers expressed as group:<br /><br>- GMT ratio (OA-RSV/Adults-HA-RSV), 1 month after the RSVPreF3 OA<br /><br>investigational vaccine administration.<br /><br>- SRR difference (OA-RSV - Adults-HA-RSV), 1 month after the RSVPreF3 OA<br /><br>investigational vaccine administration compared to baseline<br /><br><br /><br>RSV-B neutralization titers expressed as group:<br /><br>- GMT ratio (OA-RSV/Adults-HA-RSV), 1 month after the RSVPreF3 OA<br /><br>investigational vaccine administration.<br /><br>- SRR difference (OA-RSV - Adults-HA-RSV), 1 month after the RSVPreF3 OA<br /><br>investigational vaccine administration compared to baseline</p><br>
- Secondary Outcome Measures
Name Time Method