Clinical Trial 46450

Doral, FL 33166


Experimental: mRNA-1273 (Biological: mRNA-1273 Sterile liquid for injection) 

Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at up to 3 doses pre-specified for this study, 28 days apart, on Day 1 and Day 29.

Part 2: Participants will receive 2 IM injections of mRNA-1273 at the dose selected from Part 1, 28 days apart, on Day 1 and Day 29


Placebo Comparator: Placebo (Biological: Placebo 0.9% sodium chloride (normal saline) injection)

Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29. 


Ages Eligible for Study:  6 Months to 11 Years   (Child)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  Yes

Key Inclusion Criteria:

  • For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment.
  • Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow up, including all procedures, written informed consent is provided, and participants provide assent.
  • For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit.
  • For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg).
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding

Qualified Participants May Receive:

Qualified participants can be compensated for their time and transportation costs.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.