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Virus Vaccine
mRNA-1273.214 Vaccine for COVID-19 in Children
Phase 3
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with chronic diseases (asthma, diabetes mellitus, cystic fibrosis, HIV infection) must have stable disease status for at least 6 months prior to Screening Visit
Participant must be 2 years or older with a BMI at or above the 2nd percentile according to WHO Child Growth Standards, or less than 2 years with height and weight at or above the 2nd percentile
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 29 (28 days after each injection)
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new coronavirus vaccine in kids aged 6 months to 6 years old.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain and swelling, fever, fatigue, headache, muscle pain, chills and nausea. Severe allergic reactions are rare but possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My chronic condition (like asthma or diabetes) has been stable for at least 6 months.
Select...
I am 2 years or older with a healthy weight, or under 2 with proper height and weight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 29 (28 days after each injection)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 29 (28 days after each injection)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GM of the Serum Ab Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 29
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration
Geometric Mean (GM) of the Serum Antibody (Ab) Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 57
+7 moreSecondary outcome measures
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection
SRR against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Regardless of prior SARS-CoV-2 Infection
SRR against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273.815
2021
Completed Phase 3
~5410
Moderna COVID-19 Vaccine
FDA approved
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,377,457 Total Patients Enrolled
37 Trials studying COVID-19
61,258,706 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have a condition that could affect the study's safety or results.I have had COVID-19 within the last 90 days.I have not received blood products like red cells or platelets in the last 3 months.I do not have any health or mental conditions that could affect the study.I haven't had any vaccines 14 days before or plan to within 14 days after the study vaccine.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.I have not taken COVID-19 preventive drugs in the last 90 days.My child was born full-term and weighed at least 2.5 kg.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-1273.214 (Part 1)
- Group 2: mRNA-1273.214 (Part 2)
- Group 3: mRNA-1273.815 (Part 3)
- Group 4: mRNA-1273.815 (Part 4)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being selected for this clinical trial?
"The information available on clinicaltrials.gov suggests that this trial is still open to recruiting patients. This particular trial was posted on 6/21/2022 and updated as recently as 10/8/2022. So far, 960 people have been recruited from 28 different locations."
Answered by AI
Could you please elucidate the possible dangers of mRNA-1273.214 for human beings?
"There is some evidence that suggests the efficacy of mRNA-1273.214 and it has undergone multiple rounds of testing, so we believe it to be safe and have rated it a 3 on our Power scale."
Answered by AI
Are there any patients that this experiment is still recruiting?
"Yes, this trial is still recruiting patients as of October 8th, 2022. The clinical study was first posted on June 21st, 2020."
Answered by AI
Does this trial cater to young adults or is it open to people of all ages?
"Children aged 6 months to 5 years old can be enrolled in this clinical trial. Out of the 196 total trials, 31 are for drugs targeting pediatric patients and 165 cater to an elderly demographic."
Answered by AI
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