Respiratory Syncytial Virus Infection MedDRA version: 21.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
ModernaTX, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults = 60 years of age who are primarily responsible for self care and activities of daily living. Participants may have one or more chronic medical diagnoses (specifically CHF including heart failure with preserved ejection fraction and COPD), but should be medically stable as assessed by the following criteria: o Absence of changes in medical therapy within 1 month due to treatment failure or toxicity o Absence of medical events qualifying as SAEs within 1 month of the planned study injection on Day 1 o Absence of known, current, and life-limiting diagnoses, which could continue for the duration of the primary efficacy period (12 months from study injection on Day 1) and which, in the opinion of the investigator, would make completion of the protocol unlikely. 2. Body mass index from = 18 kg/m2 to = 35 kg/m2. 3. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment. 4. Able to comply with study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30240
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical research study where participant has received an investigational product (drug/biologic/device including any investigational RSV product) within 45 days before the planned date of the Day 1 study injection. 2. History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition. 3. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease. Note: Human immunodeficiency virus (HIV) positive participants with CD4 count = 350 cells/mm3 and an undetectable HIV viral load within the past year (low level variations from 50-500 viral copies which do not lead to changes in antiretroviral therapy) as determined from participant’s medical records, are permitted. 4. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid areas). 5. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 vaccine or any components of the mRNA-1345 vaccine. 6. Reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy. 7. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization. 8. Received or plans to receive any nonstudy vaccine (including authorized or approved vaccines for the prevention of coronavirus disease 2019 [COVID 19] regardless of type of vaccine) within 28 days before or after the Day 1 study injection. Nonstudy vaccination(s) should not be delayed. 9. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study injection. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose = 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. 10. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study injection or during the study. 11. Acute disease at the time of enrollment (defined as the presence of moderate or severe illness with or without fever, or an oral temperature = 37.8°C on the planned day of vaccine administration). 12. Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. 13. Known history of poorly controlled hypertension (per determination of the investigator), or systolic blood pressure > 160 mmHg at the Screening or baseline (Day 1) visit. 14. Known history of hypotension, or systolic blood pressure 90 mmHg at the Screening or baseline (Day 1) visit. 16. Known uncontrolled disorder of coagulation. Note: Participants receiving aspirin, c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the safety and tolerability of the mRNA 1345 vaccine. •To demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV LRTD as compared with placebo within the period of 14 days postinjection up to 12 months postinjection.;Secondary Objective: Key Secondary Efficacy Objectives: • To evaluate the efficacy of a single dose of mRNA 1345 vaccine in the prevention of a first episode of RSV ARD as compared with placebo within the period of 14 days postinjection up to 12 months postinjection. • To evaluate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of hospitalizations associated with RSV ARD or RSV LRTD as compared with placebo within the period of 14 days postinjection up to 12 months postinjection.;Primary end point(s): Safety endpoints: • Numbers and percentages of participants with solicited local and systemic adverse reactions (ARs) up to 7 days postinjection. • Unsolicited adverse events (AEs) up to 28 days postinjection. • Medically attended adverse events (MAAEs), adverse events of special interest (AESIs), serious adverse events (SAEs), and AEs leading to withdrawal up to 24 months postinjection. Efficacy Endpoint: • Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD within the period of 14 days postinjection up to 12 months postinjection.;Timepoint(s) of evaluation of this end point: Screening D1 (Baseline) D8 D15 D29 D60 then Monthly D181 D365 D546 D730/EOS D730/EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV ARD within the period of 14 days postinjection up to 12 months postinjection. • Vaccine efficacy of mRNA 1345 to prevent hospitalizations associated with RSV ARD or RSV LRTD within the period of 14 days postinjection up to 12 months postinjection. •Vaccine efficacy of mRNA-1345 to prevent a first episode of RSV-LRTD within the period of 14 days postinjection up to 24 months postinjection. •Vaccine efficacy of mRNA-1345 to prevent a first episode of all-cause LRTD within the period of 14 days postinjection up to 12 months postinjection. •Vaccine efficacy of mRNA-1345 to prevent all-cause hospitalizations within the period of 14 days postinjection up to 12 months postinjection.;Timepoint(s) of evaluation of this end point: Screening D1 (Baseline) D8 D15 D29 D60 then Monthly D181 D365 D546 D730/EOS | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Finland, Germany, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Panama, Poland, Puerto Rico, Singapore, South Africa, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trials
ModernaTX, Inc.
Outcome results
None listed