68 Participants Needed

mRNA-1273.214 Vaccine for Infant COVID-19

(BabyCOVE Trial)

Recruiting at 47 trial locations
MC
Overseen ByModerna Clinical Trials Support Center
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

The mRNA-1273.214 vaccine is unique because it is a bivalent booster, meaning it targets both the original strain of the virus and the Omicron variant, potentially offering broader protection against COVID-19 compared to vaccines targeting only one strain.12567

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

Parent(s)/legally authorized representative(s) understand, willing, and physically able to comply with protocol-mandated follow-up, including all procedures, and provide written informed consent
Participants with chronic, stable diseases may be eligible for Part 2 if the condition is stable per investigator assessment
I am between 12 weeks and 6 months old.
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Exclusion Criteria

Participant has a history of diagnosis or condition that may affect study endpoint assessment or compromise participant safety
Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit or plans to do so while participating in this study
I have had COVID-19 or been in close contact with someone who has, within the last 2 weeks.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

16 weeks
2 visits (in-person)

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

16 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • mRNA-1273.214
  • Placebo
Trial Overview The trial tests the safety and effectiveness of mRNA-1273.214 SARS-CoV-2 vaccine in infants compared to a placebo. Infants will receive either the vaccine or placebo to determine how well it works and monitor any reactions.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: mRNA-1273.214Experimental Treatment1 Intervention
Participants will receive 2 doses of mRNA-1273.214 by IM injection approximately 8 weeks apart (Day 1 and Day 57).
Group II: Part 1: mRNA-1273.214 Dose BExperimental Treatment1 Intervention
Participants will receive 2 doses of mRNA-1273.214 Dose B by IM injection approximately 8 weeks apart (Day 1 and Day 57).
Group III: Part 1: mRNA-1273.214 Dose AExperimental Treatment1 Intervention
Participants will receive 2 doses of mRNA-1273.214 Dose A by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).
Group IV: Part 2: PlaceboPlacebo Group1 Intervention
Participants will receive 2 doses of placebo by IM injection approximately 8 weeks apart (Day 1 and Day 57).

mRNA-1273.214 is already approved in European Union, United Kingdom, United States for the following indications:

🇪🇺
Approved in European Union as mRNA-1273.214 for:
  • Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5
🇬🇧
Approved in United Kingdom as mRNA-1273.214 for:
  • Prevention of COVID-19 caused by SARS-CoV-2 variants including Omicron BA.1 and BA.4/5
🇺🇸
Approved in United States as mRNA-1273.214 for:
  • 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

Trials
127
Recruited
66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

The bivalent COVID-19 vaccine candidate mRNA-1273.211, which targets both the ancestral SARS-CoV-2 and the Beta variant, demonstrated higher neutralizing antibody responses compared to the original mRNA-1273 booster, indicating its potential effectiveness against multiple variants.
The safety profile of the mRNA-1273.211 booster was similar to that of the original mRNA-1273 booster, suggesting that it is a safe option for enhancing immunity against COVID-19 without increasing adverse effects.
Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial.Chalkias, S., Eder, F., Essink, B., et al.[2023]
The mRNA-1273 Covid-19 vaccine was found to be safe for children aged 6 months to 5 years, with mostly low-grade and transient adverse events, and no new safety concerns identified during the trial.
The vaccine elicited immune responses in young children that were comparable to those in young adults, meeting noninferiority criteria, with estimated efficacy rates of 36.8% for children aged 2-5 years and 50.6% for those aged 6-23 months against Covid-19.
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.Anderson, EJ., Creech, CB., Berthaud, V., et al.[2023]
The bivalent mRNA-1273 COVID-19 vaccine shows a 70.3% effectiveness in preventing hospitalization for COVID-19 compared to individuals who received at least two doses of any monovalent mRNA vaccine, based on a matched cohort study.
The bivalent vaccine also provides significant protection against medically attended SARS-CoV-2 infections (55.0% effectiveness) and COVID-19 related hospital deaths (82.7% effectiveness), with durable protection lasting at least three months after the booster.
mRNA-1273 bivalent (original and Omicron) COVID-19 vaccine effectiveness against COVID-19 outcomes in the United States.Tseng, HF., Ackerson, BK., Sy, LS., et al.[2023]

Citations

Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial. [2023]
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. [2023]
mRNA-1273 bivalent (original and Omicron) COVID-19 vaccine effectiveness against COVID-19 outcomes in the United States. [2023]
Bivalent SARS-CoV-2 mRNA vaccines increase breadth of neutralization and protect against the BA.5 Omicron variant. [2023]
Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. [2021]
Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022. [2023]
A Bivalent Omicron-Containing Booster Vaccine against Covid-19. [2023]
Three-month antibody persistence of a bivalent Omicron-containing booster vaccine against COVID-19. [2023]
A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. [2022]
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