mRNA-1273.214 Vaccine for Infant COVID-19
(BabyCOVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial will test a new COVID-19 vaccine in young infants to ensure it is safe and effective. The vaccine works by using mRNA to teach the body to fight the virus.
Do I need to stop my current medications to join the trial?
The trial does not specify if participants must stop taking their current medications. However, it mentions that participants should not have received certain COVID-19 treatments or vaccines recently, and should not be on systemic immunosuppressants or immune-modifying drugs for more than 14 days in the past 6 months. It's best to discuss your specific medications with the trial team.
Is the mRNA-1273.214 vaccine generally safe for humans?
The mRNA-1273.214 vaccine, also known as the Spikevax bivalent booster, has been shown to have a safety profile similar to previous COVID-19 vaccines, with most reported side effects being mild, such as injection site reactions and general body reactions like fatigue. Serious adverse events were rare, and the vaccine's safety is consistent with other COVID-19 vaccines.12345
How is the mRNA-1273.214 vaccine different from other COVID-19 treatments?
What data supports the effectiveness of the mRNA-1273.214 treatment for infant COVID-19?
Research on similar bivalent vaccines, like mRNA-1273.211 and mRNA-1273.222, shows they can boost the body's defense against different COVID-19 variants by increasing the range and strength of antibodies. This suggests that mRNA-1273.214 might also offer strong protection against COVID-19 in infants.12689
Are You a Good Fit for This Trial?
This trial is for healthy infants aged between 2 and <6 months who were born at or after 34 weeks gestation, with a minimum birth weight of 2.5 kg. They should not have received COVID-19 prophylaxis, have no known allergies to vaccine components, and must not be acutely ill or febrile before the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Open-label phase where participants receive 2 doses of mRNA-1273.214 Dose A or Dose B by IM injection approximately 8 weeks apart
Treatment Part 2
Observer-blind, randomized phase where participants receive 2 doses of mRNA-1273.214 or placebo by IM injection approximately 8 weeks apart
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- mRNA-1273.214
- Placebo
mRNA-1273.214 is already approved in European Union, United Kingdom, United States for the following indications:
- Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5
- Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5
- Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5
Find a Clinic Near You
Who Is Running the Clinical Trial?
ModernaTX, Inc.
Lead Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris