A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above

Participants who can and will comply with the study protocol requirements

Source text: Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the electronic diary cards [eDiaries], return for follow-up visits, ability to access and utilize a phone or other electronic communications)

A male or female >= 65 YOA at the time of the first study intervention administration

Male or female >= 65 years of age at first study intervention administration

Source text: A male or female >= 65 YOA at the time of the first study intervention administration

Participants living in the general community or in an assisted-living facility with minimal assistance allowing self-care

Source text: 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

Written or witnessed informed consent obtained prior to study-specific procedures

Source text: Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure

Medically stable participants at time of first study intervention administration

Source text: Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration

Participants with chronic stable medical conditions (diabetes, hypertension, cardiac disease) allowed if medically stable

Source text: 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 by the investigator as medically stable

Medically-controlled active or chronic neurological diseases permitted if compliant with protocol

Source text: 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

Male or female

Confirmed or suspected immunosuppressive or immunodeficient condition from disease or therapy by history and physical exam

Source text: Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required)

History of reaction or hypersensitivity likely exacerbated by study intervention components, especially severe egg protein allergy or previous influenza vaccine reaction

Source text: History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to egg protein or to a previous influenza vaccine

Hypersensitivity to latex

Guillain-Barre syndrome within 6 weeks of prior influenza vaccine

Source text: Guillain-Barre syndrome that occurred within 6 weeks of receipt of prior influenza vaccine

Serious or unstable chronic illness

History of dementia or any medical condition moderately or severely impairing cognition

Source text: Any history of dementia or any medical condition that moderately or severely impairs cognition

Recurrent or uncontrolled neurological disorders or seizures

Significant underlying illness expected to prevent study completion

Source text: Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study

Any medical condition making intramuscular injection unsafe per investigator judgment

Source text: Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe

Use of any investigational or non-registered product other than study interventions within 30 days prior to first dose or planned use during study

Source text: Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or planned use during the study period

Administration of influenza vaccine within 6 months prior to study vaccine

Source text: Administration of an influenza vaccine during the 6 months preceding the study FLU vaccine administration

Planned or actual administration of vaccine not foreseen by protocol from 30 days before first study intervention until 30 days after last intervention; COVID-19 vaccine window shortened to 14 days before and after each intervention if local policy

Source text: Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. In the case of COVID-19 vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided this COVID-19 vaccine use is in line with local governmental recommendations

Previous vaccination with any RSV vaccine

Source text: Previous vaccination with an RSV vaccine

Administration or planned administration of long-acting immune-modifying drugs at any time during study period

Source text: Administration of long-acting immune-modifying drugs or planned administration at any time during the study period

Administration of immunoglobulins or blood products/plasma derivatives within 90 days prior to first dose or planned use during study period

Source text: Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions or planned administration during the study period

Chronic administration (>14 consecutive days) of immunosuppressants or immune-modifying drugs within 90 days prior to first dose or planned during study; prednisone >= 20 mg/day or equivalent; inhaled and topical steroids allowed

Source text: Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone >= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed

Concurrent participation in another clinical study with exposure to investigational or non-investigational vaccine/product

Source text: 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)

History of chronic alcohol consumption and/or drug abuse rendering participant unable or unlikely to comply with study

Source text: 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 excluded

Source text: Bedridden participants

Planned move during study conduct preventing study participation until study end

Source text: Planned move during the study conduct that prohibits participation until study end

Participation of study personnel or immediate family/dependents/household members excluded

Source text: Participation of any study personnel or their immediate dependents, family, or household members

diabetes