Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.
- - Understands and agrees to comply with the study procedures and provides written informed consent.
- - Able to comply with study procedures based on the assessment of the Investigator.
- - Female participants of non-childbearing potential may be enrolled in the study.
- - Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - Has a negative pregnancy test at Screening and on the day of the first dose (Day 1).
- - Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).
- - Has agreed to continue adequate contraception through 3 months following the second dose on Day 29.
- - Is not currently breastfeeding.
- - Healthy adults or adults with pre-existing medical conditions who are in stable condition.
- - Is acutely ill or febrile 72 hours prior to or at Screening.
- - Is pregnant or breastfeeding.
- - (Part A Only) Known history of SARS-CoV-2 infection.
- - Prior administration of an investigational coronavirus (SARS-CoV, Middle East Respiratory Syndrome [MERS]-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19.
- - (Part A Only) Demonstrated inability to comply with the study procedures.
- - (Part A Only) An immediate family member or household member of this study's personnel.
- - Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients.
- - Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
- - Has received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (except for seasonal influenza vaccine).
- - Has participated in an interventional clinical study within 28 days prior to the day of enrollment.
- - Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections.
- - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent).
- - Has received systemic immunoglobulins or blood products within 3 months prior to the day of Screening.
- - Has donated ≥450 milliliters (mL) of blood products within 28 days prior to Screening.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
This is a 2-part Phase 3 study, with Part A (Blinded Phase) and Part B (Open-label Observational Phase). Participants in Part A are blinded to their treatment assignment, with participants receiving either 2 active mRNA-1273 vaccine doses or placebo. Part B of the study is designed to offer participants to be unblinded so that participants who received placebo in Part A can request 2 doses of open-label mRNA-1273 vaccine. Additionally, participants who choose to be unblinded and was only able to receive 1 dose of mRNA-1273 due to administrative reasons, can choose to receive the second dose of mRNA-1273 during Part B. Please access www.modernatx.com/cove-study for additional information, such as Study Overview, Participation, and Site Locations along with contact numbers for each location for the study.
Part A: Participants will receive 1 intramuscular (IM) injection of 100 microgram (ug) mRNA-1273 on Day 1 and on Day 29. Part B: Participants who choose to be unblinded and received mRNA-1273-matching placebo during Part A, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1 and Day 29, if the participant chooses. Participants who choose to be unblinded and was only able to receive 1 dose of mRNA-1273 due to administrative reasons, will receive 1 IM injection of 100 ug mRNA-1273 on Day 1, if the participant chooses.
Placebo Comparator: Placebo
Part A only: Participants will receive 1 IM injection of mRNA-1273-matching placebo on Day 1 and on Day 29, if the participant chooses.
Biological: - mRNA-1273
Sterile liquid for injection
Biological: - Placebo
0.9% sodium chloride (normal saline) injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.