Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from
Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed
to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent
COVID-19 for up to 2 years after the second dose of mRNA-1273.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Infectious Diseases
Enrollment Eligibility
Inclusion Criteria:
- (Part A only) 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.
Non-childbearing potential is defined as surgically sterile (history of bilateral
tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as
amenorrhea for ≥12 consecutive months prior to Screening without an alternative
medical cause). A follicle-stimulating hormone (FSH) level may be measured at the
discretion of the Investigator to confirm postmenopausal status.
- 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, open-label Day 1, and booster 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 last
dose (Day 29, open-label Day 29, and booster dose Day 1).
- Is not currently breastfeeding.
- Healthy adults or adults with pre-existing medical conditions who are in stable
condition. A stable medical condition is defined as disease not requiring significant
change in therapy or hospitalization for worsening disease during the 3 months before
enrollment.
- (Part C Only) Is currently enrolled in Part B of the current study (mRNA-1273-P301).
- (Part C Only) Has received at least 1 dose of mRNA-1273 in the current study
(mRNA-1273-P301).
Exclusion Criteria:
- Is acutely ill or febrile 72 hours prior to or at Screening or dosing (Part B and Part
C). Fever is defined as a body temperature ≥38.0°Celsius/100.4°Fahrenheit.
Participants meeting this criterion may be rescheduled within the relevant window
periods. Afebrile participants with minor illnesses can be enrolled/dosed at the
discretion of the Investigator.
- Is pregnant or breastfeeding.
- (Part A Only) Known history of SARS-CoV-2 infection.
- Prior (Part A) or concurrent (Part B and Part C) administration of non-study
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.
- 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 (IP) (except for seasonal influenza vaccine).
- (Part A only) 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 IP dose administration (for corticosteroids ≥20
milligram (mg)/day of prednisone equivalent).
- Has received systemic immunoglobulins or blood products within 3 months prior to the
day of IP dose administration.
- Has donated ≥450 milliliters (mL) of blood products within 28 days prior to IP dose
administration.
Accepts Healthy Volunteers
Call +1 (305) 2439034