mRNA-1273.214 Vaccine for COVID-19 in Children

Recruiting at67 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Monoclonal antibodies

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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 COVID-19 virus and a variant, providing broader protection against multiple strains. This approach is different from earlier vaccines that targeted only the original virus. ^{1 3 4 8 9}

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

My chronic condition (like asthma or diabetes) has been stable for at least 6 months.

I received two doses of the mRNA-1273 vaccine, 28-35 days apart, at least 4 months ago.

I am 2 years or older with a healthy weight, or under 2 with proper height and weight.

Exclusion Criteria

I haven't taken immune-suppressing drugs for more than 2 weeks in the last 6 months.

I have not been seriously ill or had a fever in the last 24 hours.

I have received a COVID-19 vaccine that is not mRNA-1273.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mRNA-1273.214 or mRNA-1273.815 vaccines as per their cohort assignment

4 weeks

2 visits (in-person)

Booster Dose Administration

Participants receive a booster dose of mRNA-1273.214 or mRNA-1273.815 vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after vaccine administration

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• mRNA-1273.214 (Virus Vaccine)

Trial Overview The trial is testing the safety and immune response to the mRNA-1273.214 COVID-19 vaccine in young children. It involves two parts: one for those who haven't been vaccinated and another for those previously given two doses of mRNA-1273 as a primary series.

Participant Groups

Group I: mRNA-1273.815 (Part 4) Experimental Treatment 1 Intervention

Participants in Part 4 Cohort A will receive a single IM injection of mRNA-1273.815 vaccine on Day 1. Participants in Part 4 Cohort B will receive IM injections of mRNA-1273.815 vaccine on Day 1 and Day 29.

Group II: mRNA-1273.815 (Part 3) Experimental Treatment 1 Intervention

Participants who have previously been vaccinated with an authorized/approved COVID-19 vaccine, will receive a single IM BD of mRNA-1273.815 vaccine on BD Day 1, at least 4 months after the last dose of a COVID-19 vaccine.

Group III: mRNA-1273.214 (Part 2) Experimental Treatment 1 Intervention

Participants who have previously been vaccinated with a mRNA-1273 primary series, will receive a single IM BD of mRNA-1273.214 vaccine at least 4 months after completion of the mRNA-1273 primary series.

Group IV: mRNA-1273.214 (Part 1) Experimental Treatment 1 Intervention

Participants who have not been previously vaccinated against SARS-CoV-2, will receive 2 intramuscular (IM) injections of mRNA-1273.214 vaccine on Day 1 and Day 29.

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

Findings from Research

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]

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]

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]

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]

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]

In a study of 604 adolescents in Riyadh, Saudi Arabia, the most common side effects reported after receiving the Pfizer-BioNTech and Spikevax COVID-19 vaccines were pain at the injection site, fatigue, and headaches, with 85.1% and 79.8% reporting pain after the first and second doses, respectively.

Adolescents with chronic diseases experienced significantly higher odds of specific side effects, such as menstrual disorders and breathing congestion, compared to those without chronic conditions, highlighting the need for tailored information regarding vaccine side effects based on individual health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluate the side effect associated with COVID-19 vaccine on adolescents in Riyadh, Saudi Arabia: A cross-section study. Aldali, JA., Alotaibi, FT., Alasiri, GA., et al.[2022]

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 vaccine (50 μg) was found to be safe for children aged 6 to 11, with mainly low-grade side effects like injection-site pain and fatigue, and no serious adverse events reported.

The vaccine demonstrated an efficacy of 88.0% in preventing Covid-19 in children, with immune responses comparable to those seen in young adults, indicating it is effective for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. Creech, CB., Anderson, E., Berthaud, V., et al.[2023]

mRNA vaccines BNT162b2 and mRNA-1273 are effective in preventing SARS-CoV-2 infection in children and adolescents, significantly reducing the risk of severe disease and hospitalization.

While common side effects include pain, fatigue, and headache, serious side effects like myocarditis and pericarditis are rare, and monitoring can help mitigate risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SARS-CoV-2 vaccines in children and adolescents: Can immunization prevent hospitalization? Liang, KH., Hung, KF., Wang, ML., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Bivalent SARS-CoV-2 mRNA vaccines increase breadth of neutralization and protect against the BA.5 Omicron variant. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. [2023]

4. United States 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

mRNA-1273 bivalent (original and Omicron) COVID-19 vaccine effectiveness against COVID-19 outcomes in the United States. [2023]

6. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Evaluate the side effect associated with COVID-19 vaccine on adolescents in Riyadh, Saudi Arabia: A cross-section study. [2022]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

SARS-CoV-2 vaccines in children and adolescents: Can immunization prevent hospitalization? [2023]