mRNA-1273.214 Vaccine for COVID-19 in Children
Trial Summary
What is the purpose of this trial?
This trial tests updated COVID-19 vaccines on young children. The vaccines use mRNA to teach the body to recognize and fight the virus. The study aims to ensure these vaccines are safe and effective for this age group.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like systemic immunosuppressants or immune-modifying drugs may affect eligibility if taken in the 6 months prior to enrollment. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the mRNA-1273.214 drug for COVID-19 in children?
Research shows that bivalent vaccines like mRNA-1273.214, which target both the original and new variants of the virus, can produce strong and broad immune responses. These vaccines have been effective in increasing protection against various COVID-19 strains, including the Omicron variant, in both animal studies and human trials.12345
Is the mRNA-1273.214 vaccine generally safe for humans?
The mRNA-1273.214 vaccine, also known as the Spikevax bivalent booster, has been studied in adults and shown to have a safety profile similar to previous COVID-19 vaccines, with most side effects being mild, such as injection site reactions and general body reactions like fatigue. Serious side effects were rare, and the vaccine's safety is consistent with other COVID-19 vaccines.13467
How is the mRNA-1273.214 vaccine different from other COVID-19 treatments?
Research Team
Eligibility Criteria
Healthy children aged 6 months to less than 6 years, with normal growth standards, who have either not received a COVID-19 vaccine or had two doses of mRNA-1273 at least four months prior. Children with stable chronic diseases can join. Those acutely ill, febrile, or previously infected with SARS-CoV-2 within the last 90 days are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mRNA-1273.214 or mRNA-1273.815 vaccines as per their cohort assignment
Booster Dose Administration
Participants receive a booster dose of mRNA-1273.214 or mRNA-1273.815 vaccine
Follow-up
Participants are monitored for safety and immunogenicity after vaccine administration
Treatment Details
Interventions
- mRNA-1273.214 (Virus Vaccine)
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