BabyCove Study

---

Purpose: 

The primary purpose of the BabyCove Study is to evaluate the safety and reactogenicity of 2 dose levels of mRNA-1273.214 vaccine administered as 2 doses 8 weeks apart in participants aged 12 weeks to < 6 months.

What to Expect: 

Participation in the BabyCove Study lasts approximately 15 months which includes 1 month for screening, 2 months for dosing, and 12 months of follow-up after the second dose.

• Your child will be given two injections in the upper arm – about 57 days apart. Your child has a chance of receiving either the mRNA-1273.214 study vaccine or the placebo. By using a placebo, medical researchers are able to understand if the study vaccine is effective in preventing COVID-19.

• You and your child will be closely monitored for safety and will remain at the study site for observation for at least 60 minutes after dosing in Part 1 and 30 minutes after dosing in Part 2, On day 57, the second dose will be administered. 

• Participants will be followed for 12 months after the second dose. asked to return to the study site up to six times depending on their enrollment assignment.

• You will be asked to use an eDiary app on your smartphone or a provided smartphone to report any COVID-19 symptoms your child experiences.

• Your child will be closely monitored by the study team if any symptoms of COVID-19 are reported at any time throughout their participation.

The study doctor and medical staff will talk to you and your child about additional medical support that your child will receive if he/she experiences COVID-19 symptoms at any time while in this clinical trial. Insurance is not needed to join this clinical trial, and compensation for your family’s time will be available.

Eligibility Criteria: 

Participant must: 

• Be between 12 weeks to < 6 months old
• Be in good health

Participant must not: 

• Have received an investigational or approved vaccine for COVID-19
• Be currently taking any investigational or approved treatments for COVID-19
• Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to vaccine administration
• Have participated in another COVID-19 trial in the past month

Length / Duration:  

Participation in the BabyCove Study lasts approximately 15 months and includes phone calls, telemedicine visits, and multiple visits to the study site.

Location:  

13229 Hillsdale Lane, Kissimmee, Florida 34741, United States

Who should you contact: 

Recruitment Department: (407) 350-3979