Overview
The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (>=) 60 YOA and above
Eligibility
Inclusion Criteria:
- Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications).
- Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
Written informed assent obtained from the participant (participant must be able to
understand the informed assent) if he/she is less than the legal age prior to performance
of any study-specific procedure.
Specific inclusion criteria for all participants in Cohort 1 • A male or female participant
18-49 YOA at the time of the study intervention administration.
- Participants should be diagnosed with at least 1 of the following medical conditions
if considered medically stable by the investigator:
- Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of
long term medication:
o Chronic obstructive pulmonary disease (COPD)
o Asthma
o Cystic fibrosis
o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease,
interstitial lung disease, emphysema or bronchiectasis
o Chronic heart failure:
o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified)
- Cardiac arrhythmia
- Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months
- Other diseases at increased risk for RSV disease:
- Chronic kidney disease
- Chronic moderate to severe liver disease
- Neurologic or neuromuscular conditions
- Female participants of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as premenarche, hysterectomy, bilateral
oophorectomy, bilateral salpingectomy or post-menopause.
- 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, and
- has a negative pregnancy test on the day of study prior to intervention
administration, and
- has agreed to continue adequate contraception for at least 1 month after
completion of the study intervention administration.
Specific inclusion criteria for all participants in Cohort 2
• A male or female participant >=60 YOA at the time of the study intervention
administration.
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
if considered medically stable by the investigator.
• Participants living in the general community or in an assisted-living facility that
provides minimal assistance, such that the participant is primarily responsible for
self-care and activities of daily living.
Exclusion Criteria:
Medical conditions
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
from disease (e.g., current malignancy, human immunodeficiency virus) or
immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy,
organ transplantation, or to treat autoimmune disorders), based on medical history and
physical examination (no laboratory testing required).
- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the study intervention.
- Unstable chronic illness.
- Any history of dementia or any medical condition that moderately or severely impairs
cognition.
- Recurrent or uncontrolled neurological disorders or seizures. Participants with
medically controlled active or chronic neurological diseases can be enrolled in the
study as per investigator assessment, provided that their condition will allow them to
comply with the requirements of the protocol (e.g., completion of the diary cards,
attend study site visits). Study participants may decide to assign a caregiver to help
them complete the study procedures.
- Significant underlying illness that in the opinion of the investigator would be
expected to prevent completion of the study (e.g., life-threatening disease).
- Any 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.
Prior/Concomitant therapy
- Use of any investigational or non-registered product (drug, vaccine, or medical
device) other than the study intervention during the period beginning 30 days before
the dose of study intervention (Day -29 to Day 1), or planned use during the study
period (up to Visit 3, Month 6).
- 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, subunit and split
influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before
or from 14 days after the study intervention administration.
- Previous vaccination with any RSV vaccine, including investigational RSV vaccines.
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive
days in total) and/or administration of long-acting immune-modifying treatments or
planned administration at any time up to the End-of-study (EOS).
- Up to 3 months prior to the study intervention administration:
- For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent.
Inhaled, topical and intra-articular steroids are allowed
- Administration of immunoglobulins and/or any blood products or plasma
derivatives
- Up to 6 months prior to study intervention administration: long-acting
immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis
Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication.
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 (drug or invasive medical device).
Other exclusions:
Other exclusions for all participants
- History of chronic alcohol consumption and/or drug abuse as deemed by the investigator
to render the potential participant unable/unlikely to provide accurate safety reports
or comply with study procedures.
- Bedridden participants.
- Planned move during the study period that will prohibit participating in the study
until study end.
- Participation of any study personnel or their immediate dependents, family, or
household members.
Other exclusions for Cohort 1
- Pregnant or lactating female participant.
- Female planning to become pregnant or planning to discontinue contraceptive
precautions within 1 month after study intervention administration.