A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults

Exclusion Criteria31

• Participants are excluded from participating in the study if any of the following criteria apply:
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
• Any medical condition that in the judgment of the investigator would make IM injection unsafe.
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) 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).
• Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
• Documented history of HIV, HBV, HCV infection.
• History of RSV and /or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months.
• Recurrent history or uncontrolled neurological disorders or seizures, or history of demyelinating conditions (including GBS).
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
• Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before study intervention administration (Day -29 to Day 1), or within 5 half-lives, whichever is longer, or their planned use during the study period.
• Has previously received an investigational or approved vaccine or antibody for prevention of hMPV and/or RSV-associated diseases.
• Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
• Up to 3 months prior to the study intervention administration:
• For corticosteroids, this will mean prednisone equivalent >=20 mg/day for adult participants. 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., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
• 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 intervention.
• 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.
• Participation of any study personnel or their immediate dependents, family, or household members.
• Planned move during the study period that will prohibit participating in the study until study end.
• Bedridden participants.
• Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after 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.
• At screening (Phase 1 only): Any laboratory abnormality. Grade 1 laboratory abnormalities that are not-clinically significant* may be included in the study.
• The investigators should use their clinical judgment to decide which abnormalities are clinically significant.
• Pregnant or lactating participant.
• Female planning to become pregnant or planning to discontinue contraceptive precautions for 8 weeks after study intervention administration.
• Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration.
• At screening: Any hematologic and/or biochemical laboratory abnormality.
• Use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's wort) beginning 14 days (or 5 half-lives) prior to study intervention administration and/or planned administration during the study period. Certain medications may be permitted (Eg: contraceptives for POCBP).