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Moderna mRNA 1273 study

Title A Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
Therapeutic Area Covid-19
Principal Investigator Andrew Siesennop, MD
Max Age 12 Years
Gender Any
Contact Lauren Tobias
More Information


This study is being conducted in healthy children from age 6 months to age 12 years. The study is looking at how well the Moderna mRNA vaccine works when given to healthy children for the prevention of COVID-19. 

Study Details

Inclusion Criteria

  • Age 6 months to < 12 years (Children 6 months to < 2 years should have been born at ≥ 37 weeks of pregnancy with at least 2.5 Kg at the time they were born)
  • Healthy or have a stable, chronic medical condition
  • Able and willing to provide blood sample on the first study visit

Exclusion Criteria

  • Participant has had a COVID-19 infection within 2 weeks before receiving the vaccine or has had close contact with someone with COVID-19 2 weeks before receiving the vaccine
  • Has fever at the time of screening visit or another acute illness
  • Has received another approved vaccine or medication for COVID-19

Study Requirements

The study lasts for about 14 months in total with at least 6 study visits. After signing the informed consent, participants will be divided randomly to get the study vaccine or an injection of salt water called placebo. The study vaccine will be given on 2 days; Day 1 and Day 29.

The following could happen at all or some study visits:

  1. Check health history
  2. Listen to heart rate
  3. Check height and weight
  4. Check temperature
  5. About 2- 5 teaspoons of blood will be collected depending on the child’s age. This amount is for the total time that the child is in the study.
A nasal swab which is similar to a cotton swab will be collected