mRNA-1273.214 Vaccine for COVID-19 in Children
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: ModernaTX, Inc.
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.
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you must stop taking your current medications. However, if you are on systemic immunosuppressants or immune-modifying drugs, you should not have taken them for more than 14 days in total within 6 months prior to enrollment. Inhaled, nasal, and topical steroids are allowed. It's best to discuss your specific medications with the trial investigator.
Is the mRNA-1273.214 vaccine a promising treatment for COVID-19 in children?Yes, the mRNA-1273.214 vaccine, also known as the Spikevax bivalent booster, is a promising treatment for COVID-19 in children. It is designed to protect against multiple variants of the virus, which means it can help prevent severe illness and hospitalization. The vaccine has shown strong and lasting immune responses, making it a valuable tool in fighting COVID-19.12345
What safety data exists for the mRNA-1273.214 COVID-19 vaccine in children?The safety data for the mRNA-1273.214 vaccine, also known as the Spikevax bivalent booster, is primarily derived from studies on similar bivalent vaccines like mRNA-1273.211. These studies indicate that the safety and reactogenicity profile of bivalent boosters is similar to that of the original mRNA-1273 vaccine. In a U.S. safety surveillance study, adverse events reported after bivalent booster doses were consistent with those reported after monovalent doses, with most being non-serious. However, specific safety data for children is not detailed in the provided research.14578
What data supports the idea that mRNA-1273.214 Vaccine for COVID-19 in Children is an effective treatment?The available research shows that the mRNA-1273.214 vaccine, which is a bivalent vaccine, can provide strong protection against COVID-19. It has been shown to increase the body's ability to fight off different variants of the virus, including the Omicron variant. In studies, this vaccine has been effective in preventing severe outcomes like hospitalization and death from COVID-19. Compared to those who only received earlier versions of the vaccine, people who got the bivalent booster had a 70.3% lower chance of being hospitalized due to COVID-19. This suggests that the mRNA-1273.214 vaccine is a powerful tool in protecting against the virus, especially as new variants emerge.14569
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 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.
I haven't had any vaccines 14 days before or plan to within 14 days after the study vaccine.
Treatment Details
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.
4Treatment groups
Experimental Treatment
Group I: mRNA-1273.815 (Part 4)Experimental Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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.
mRNA-1273.214 is already approved in European Union, United Kingdom, Australia, 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 Australia 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
Research locations nearbySelect from list below to view details:
University of Missouri Health CareColumbia, MO
Lurie Childrens HospitalChicago, IL
Quality Clinical ResearchOmaha, NE
Velcocity Clinical ResearchMeridian, ID
More Trial Locations
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
References
Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. [2021]The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study ( NCT04405076 ) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P
Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. [2023]Vaccination of children to prevent coronavirus disease 2019 (Covid-19) is an urgent public health need. The safety, immunogenicity, and efficacy of the mRNA-1273 vaccine in children 6 to 11 years of age are unknown.
SARS-CoV-2 vaccines in children and adolescents: Can immunization prevent hospitalization? [2023]The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its variants of concern can infect people of all ages and can cause severe diseases in children, such as encephalitis, which require intensive care. Therefore, vaccines are urgently required to prevent severe disease in all age groups. We reviewed the safety and efficacy profiles of mRNA vaccines-BNT162b2 and mRNA-1273-demonstrated by clinical trials or observed in the real world. mRNA-1273 is effective in preventing SARS-CoV-2 infection in preschool children (6 months-6 years old). Both BNT162b2 and mRNA-1273 are effective in preventing SARS-CoV-2 infection in school-aged children and adolescents, thereby preventing post-coronavirus disease (COVID) conditions. The common side effects of vaccination are pain at the injection site, fatigue, and headache. Myocarditis and pericarditis are uncommon. Monitoring post-vaccination troponin levels may help prevent severe cardiac events. The SARS-CoV-2 coronavirus mutates its genome to overcome the herd immunity provided by mass vaccinations; therefore, we may need to develop new generations of vaccines, such as those using viral nucleocapsid proteins as antigens. In conclusion, the mRNA vaccines are generally safe and effective in preventing severe diseases and hospitalization among children and adolescents.
Safety, immunogenicity and antibody persistence of a bivalent Beta-containing booster vaccine against COVID-19: a phase 2/3 trial. [2023]Updated immunization strategies are needed to address multiple severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. Here we report interim results from an ongoing, open-label phase 2/3 trial evaluating the safety and immunogenicity of the bivalent Coronavirus Disease 2019 (COVID-19) vaccine candidate mRNA-1273.211, which contains equal mRNA amounts encoding the ancestral SARS-CoV-2 and Beta variant spike proteins, as 50-µg (n = 300) and 100-µg (n = 595) first booster doses administered approximately 8.7-9.7 months after the mRNA-1273 primary vaccine series ( NCT04927065 ). The primary objectives were to evaluate the safety and reactogenicity of mRNA-1273.211 and to demonstrate non-inferior antibody responses compared to the mRNA-1273 100-µg primary series. Additionally, a pre-specified immunogenicity objective was to demonstrate superior antibody responses compared to the previously authorized mRNA-1273 50-µg booster. The mRNA-1273.211 booster doses (50-µg or 100-µg) 28 days after immunization elicited higher neutralizing antibody responses against the ancestral SARS-CoV-2 and Beta variant than those elicited 28 days after the second mRNA‑1273 dose of the primary series ( NCT04470427 ). Antibody responses 28 days and 180 days after the 50-µg mRNA-1273.211 booster dose were also higher than those after a 50-µg mRNA-1273 booster dose ( NCT04405076 ) against the ancestral SARS-CoV-2 and Beta, Omicron BA.1 and Delta variants, and all pre-specified immunogenicity objectives were met. The safety and reactogenicity profile of the bivalent mRNA-1273.211 booster (50-µg) was similar to the booster dose of mRNA-1273 (50-µg). Immunization with the primary series does not set a ceiling to the neutralizing antibody response, and a booster dose of the bivalent vaccine elicits a robust response with titers that are likely to be protective against COVID-19. These results indicate that bivalent booster vaccines can induce potent, durable and broad antibody responses against multiple variants, providing a new tool in response to emerging variants.
Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. [2023]The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown.
Bivalent SARS-CoV-2 mRNA vaccines increase breadth of neutralization and protect against the BA.5 Omicron variant. [2023]The emergence of SARS-CoV-2 variants in the Omicron lineage with large numbers of substitutions in the spike protein that can evade antibody neutralization has resulted in diminished vaccine efficacy and persistent transmission. One strategy to broaden vaccine-induced immunity is to administer bivalent vaccines that encode for spike proteins from both historical and newly-emerged variant strains. Here, we evaluated the immunogenicity and protective efficacy of two bivalent vaccines that recently were authorized for use in Europe and the United States and contain two mRNAs encoding Wuhan-1 and either BA.1 (mRNA-1273.214) or BA.4/5 (mRNA-1273.222) spike proteins. As a primary immunization series in BALB/c mice, both bivalent vaccines induced broader neutralizing antibody responses than the constituent monovalent vaccines (mRNA-1273 [Wuhan-1], mRNA-1273.529 [BA.1], and mRNA-1273-045 [BA.4/5]). When administered to K18-hACE2 transgenic mice as a booster at 7 months after the primary vaccination series with mRNA-1273, the bivalent vaccines induced greater breadth and magnitude of neutralizing antibodies compared to an mRNA-1273 booster. Moreover, the response in bivalent vaccine-boosted mice was associated with increased protection against BA.5 infection and inflammation in the lung. Thus, boosting with bivalent Omicron-based mRNA-1273.214 or mRNA-1273.222 vaccines enhances immunogenicity and protection against currently circulating SARS-CoV-2 strains.
Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022. [2023]On August 31, 2022, the Food and Drug Administration (FDA) authorized bivalent formulations of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines; these vaccines include mRNA encoding the spike protein from the original (ancestral) strain of SARS-CoV-2 (the virus that causes COVID-19) and from the B.1.1.529 (Omicron) variants BA.4 and BA.5 (BA.4/BA.5). These bivalent mRNA vaccines were authorized for use as a single booster dose ≥2 months after completion of primary series or monovalent booster vaccination; Pfizer-BioNTech bivalent booster was authorized for persons aged ≥12 years and Moderna for adults aged ≥18 years.*,† On September 1, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended that all persons aged ≥12 years receive an age-appropriate bivalent mRNA booster dose.§ To characterize the safety of bivalent mRNA booster doses, CDC reviewed adverse events and health impacts reported after receipt of bivalent Pfizer-BioNTech and Moderna booster doses during August 31-October 23, 2022, to v-safe,¶ a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and the Vaccine Adverse Event Reporting System (VAERS),** a U.S. passive vaccine safety surveillance system managed by CDC and FDA (1). During August 31-October 23, 2022, approximately 14.4 million persons aged ≥12 years received a bivalent Pfizer-BioNTech booster dose, and 8.2 million adults aged ≥18 years received a bivalent Moderna booster dose.†† Among the 211,959 registrants aged ≥12 years who reported receiving a bivalent booster dose to v-safe, injection site and systemic reactions were frequently reported in the week after vaccination (60.8% and 54.8%, respectively); fewer than 1% of v-safe registrants reported receiving medical care. VAERS received 5,542 reports of adverse events after bivalent booster vaccination among persons aged ≥12 years; 95.5% of reports were nonserious and 4.5% were serious events. Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses. Health impacts after COVID-19 vaccination are less frequent and less severe than those associated with COVID-19 illness (2).
Evaluate the side effect associated with COVID-19 vaccine on adolescents in Riyadh, Saudi Arabia: A cross-section study. [2022]To investigate the side effects of Pizer- BioNTech mRNA (BNT162b2) and Spikevax (mRNA- 1273) Coronavirus disease 2019 (COVID-19) vaccines on adolescents in Riyadh, Saudi Arabia.
mRNA-1273 bivalent (original and Omicron) COVID-19 vaccine effectiveness against COVID-19 outcomes in the United States. [2023]The bivalent (original and Omicron BA.4/BA.5) mRNA-1273 COVID-19 vaccine was authorized to offer broader protection against COVID-19. We conducted a matched cohort study to evaluate the effectiveness of the bivalent vaccine in preventing hospitalization for COVID-19 (primary outcome) and medically attended SARS-CoV-2 infection and hospital death (secondary outcomes). Compared to individuals who did not receive bivalent mRNA vaccination but received ≥2 doses of any monovalent mRNA vaccine, the relative vaccine effectiveness (rVE) against hospitalization for COVID-19 was 70.3% (95% confidence interval, 64.0%-75.4%). rVE was consistent across subgroups and not modified by time since last monovalent dose or number of monovalent doses received. Protection was durable ≥3 months after the bivalent booster. rVE against SARS-CoV-2 infection requiring emergency department/urgent care and against COVID-19 hospital death was 55.0% (50.8%-58.8%) and 82.7% (63.7%-91.7%), respectively. The mRNA-1273 bivalent booster provides additional protection against hospitalization for COVID-19, medically attended SARS-CoV-2 infection, and COVID-19 hospital death.