Clinical Trial 51842

Kissimmee, FL 34741


Summary:

This study purpose is to study tolerability, reactogenicity, and effectiveness of severe respiratory syndrome coronavirus 2 vaccine (mRNA-1273.214 SARS-CoV-2 (COVID-19)), in subjects 12 weeks to <6months. The study will be conducted broken into two groups, A and B will have participants with different dosages, and will be administered second dosage within 8 weeks. Another group C and D will be receive respiratory syndrome coronavirus vaccine or other group will receive placebo. The Study is approximately 27 months after completion of the primary series. 



Criteria:

Participants Aged 12 Weeks to < 6 Months with good general health, in the opinion of the Principal Investigator

Parent or Gardian must sign Consent form

If the participant has a chronic, stable disease, they may be eligible to enroll in Part 2, but ineligible for Part 1, determined by the Principal Investigator .

Participant was born at ≥ 37 weeks gestation (Part 1) or ≥ 34 weeks gestation (Part 2), with a minimum birth weight of 2.5 kg, without fetal growth restriction, determined by the Prinicpal investigator

Will not be eligiable if the subject has/or known its history of symptomatic SARS-CoV-2 infection within 2 weeks prior to administration of investigational product (IP), may be rescreended with in 14 days provided, determined by the principal investigator

Will not be eligiable if the participant has previously been administered an investigational or approved coronavirus (CoV) (eg, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome-CoV) vaccine.


Qualified Participants May Receive:

Part 1 mRNA-1273.214 potential dosage 5 µg or 10 µg dose level 

Part 2 mRNA-1273.214 one of 5 µg or 10 µg dose level or placebo


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.