mRNA-1273.214 Vaccine for Infant COVID-19

(BabyCOVE Trial)

No longer recruiting at 48 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Blood products

Disqualifiers: SARS-CoV-2 infection, Fever, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mRNA-based vaccine designed to protect infants from COVID-19. Researchers aim to assess the vaccine's safety, effectiveness, and infant tolerance. Different doses of the vaccine, known as mRNA-1273.214 or Spikevax bivalent booster, are being tested, with some infants receiving a placebo (a harmless, inactive substance). Infants aged 12 weeks to just under 6 months, who are in good health and were born at or after 34 weeks of gestation, may be eligible to participate. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important early-stage findings.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the mRNA-1273.214 vaccine, also known as Spikevax, has been tested in various groups. In earlier studies, adults and older children generally tolerated the vaccine well. Common side effects included soreness at the injection site, tiredness, and mild fever, similar to those seen with other vaccines.

Reports of more serious reactions, such as capillary leak syndrome (a rare condition where fluid leaks from small blood vessels), are very rare. Most studies have focused on older people, not infants.

This trial is in Phase 2, indicating that the vaccine has already passed initial safety checks in earlier studies. This phase emphasizes evaluating the vaccine's effectiveness and continues to monitor safety. While the safety of the vaccine in infants is still under study, existing data in other age groups suggests it is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Researchers are excited about the mRNA-1273.214 vaccine for infant COVID-19 because it represents a cutting-edge approach to immunization. Unlike traditional vaccines that use weakened or inactivated viruses, this vaccine uses messenger RNA (mRNA) technology to instruct cells to produce a protein that triggers an immune response. This method is not only innovative but also allows for faster development and adaptation to new variants compared to conventional vaccines. Additionally, the mRNA-1273.214 vaccine's ability to be rapidly updated makes it a promising tool for staying ahead of evolving virus strains, offering potentially broader and more effective protection for infants.

What evidence suggests that the mRNA-1273.214 vaccine could be an effective treatment for COVID-19 in infants?

Research has shown that the mRNA-1273.214 vaccine, also known as Spikevax, works well in children as young as 6 months old. In this trial, participants will receive different doses of the mRNA-1273.214 vaccine or a placebo. Studies have found that the immune response in young children mirrors that in adults, suggesting the vaccine can help prevent COVID-19 in this age group. Trials with older children and adults demonstrated the vaccine's strong ability to help the body fight the virus. It is designed to protect against multiple strains of the virus, making it a strong option for protection. Overall, evidence supports its potential to keep young children safe from COVID-19. ^{1 2 4 6 7}

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.

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.

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?

Group I: Part 2: mRNA-1273.214 Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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: Placebo Placebo Group 1 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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Bivalent vaccines encoding spike proteins from both the original Wuhan strain and Omicron variants (BA.1 or BA.4/5) induced broader neutralizing antibody responses in mice compared to monovalent vaccines, suggesting enhanced immunogenicity.

Boosting with these bivalent vaccines provided greater protection against BA.5 infection and reduced lung inflammation, indicating their potential effectiveness against currently circulating SARS-CoV-2 variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bivalent SARS-CoV-2 mRNA vaccines increase breadth of neutralization and protect against the BA.5 Omicron variant. Scheaffer, SM., Lee, D., Whitener, B., et al.[2023]

A booster dose of the mRNA-1273 COVID-19 vaccine significantly increased neutralizing antibody levels against the original virus and key variants of concern, indicating enhanced immune response after waning immunity from the initial two-dose series.

Both the mRNA-1273 booster and variant-modified boosters were found to be safe and well-tolerated, suggesting they could be effective options for improving protection against emerging SARS-CoV-2 variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. Choi, A., Koch, M., Wu, K., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The FDA authorized bivalent COVID-19 vaccines from Pfizer-BioNTech and Moderna, which target both the original virus and the Omicron variants, for booster doses in individuals aged 12 and older, with over 14 million doses administered by October 2022.

Safety data from the CDC indicated that while injection site and systemic reactions were common (60.8% and 54.8% respectively), serious adverse events were rare (4.5%), and overall, the side effects were consistent with those from previous monovalent vaccines, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022. Hause, AM., Marquez, P., Zhang, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. Anderson, EJ., Creech, CB., Berthaud, V., et al.[2023]

Citations

1.

ema.europa.eu

ema.europa.eu/en/medicines/human/EPAR/spikevax

Spikevax (previously COVID-19 Vaccine Moderna) - EMA

These results indicate that the efficacy of Spikevax in children 6 months to 11 years old is similar to that in adults. Additional data showed that subsequent ...

2.

fda.gov

fda.gov/media/155675/download

Package Insert - SPIKEVAX

The safety analysis set included 511 participants in the Moderna COVID-19. Vaccine, Bivalent booster dose group and 376 participants in the ...

3.

products.modernatx.com

products.modernatx.com/spikevaxpro/efficacy

Spikevax® (COVID-19 Vaccine, mRNA) Efficacy & Safety

Seroresponse results: The rate difference was 53.9. Seroresponse was 90.9 (86.2, 94.4; 95% CI) for participants (n=209) who received the bivalent booster ( ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10797659/

Effectiveness of the adapted bivalent mRNA COVID-19 ...

Of the total, 70% of cases (n = 518) and 66% of controls (n = 2,012) were vaccinated with a bivalent booster, while 30% (n = 225) of cases and ...

5.

fda.gov

fda.gov/media/187814/download?attachment

July 9, 2025 Clinical Review Memo - SPIKEVAX

effectiveness of Spikevax in this age cohort, if previously COVID-19 vaccinated: • Noninferior immune responses following an additional ...

6.

fda.gov

fda.gov/media/144638/download

Moderna COVID-19 Vaccine EUA Fact Sheet for ...

Data have not yet been submitted to FDA on administration of SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, or Moderna COVID-19 Vaccine, Bivalent ...

7.

ema.europa.eu

ema.europa.eu/en/documents/product-information/spikevax-epar-product-information_en.pdf

Spikevax | EMA

A few cases of capillary leak syndrome (CLS) flare-ups have been reported in the first days after vaccination with Spikevax. Healthcare professionals should ...