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Vaccine

mRNA COVID-19 Vaccine for Children

Q: What sets this particular trial apart from others like it?

Research into mRNA-1273 began in 2020 with a trial sponsored by ModernaTX, Inc. Since the initial Phase 1 study there have been 28 more clinical trials across 22 countries and 219 cities.

Q: Are there previous examples of mRNA-1273's efficacy?

Originally, mRNA-1273 was studied in 2020 at Kaiser Permanente <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> Health Research Institute - Vaccines and Infectious Diseases. So far, there have been a total of 18283 completed studies. Presently, 28 live trials are underway; many of these based in Port Lavaca, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>.

Q: Are there any sites conducting this research in North America?

Currently, there are a total of 34 clinical trial sites. These locations include Port Lavaca, Savannah, and Austin. Participants can choose the site that is most convenient for them to help reduce travel time and costs.

Q: What is the minimum age requirement for participants in this clinical trial?

Patients that want to enroll in this clinical trial must be between 6 months and 11 years old—a total of 145 studies are for patients younger than 18 whereas 997 are for those over 65.

Q: Out of the total number of people who qualify, how many will this research project be able to help?

In order to have statistically significant results, 13575 patients that meet the given inclusion criteria must enroll. Two possible locations for patients to take part in this study are Crossroads Clinical Research (Victoria) located in Port Lavaca, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> and iresearch Savannah situated in Savannah, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>.

Q: Are there any enrolment restrictions for this clinical trial?

This clinical trial is looking for 13575 people with <a href="https://www.withpower.com/clinical-trials/covid">covid</a>-19 aged 6 Months and 11. Most notable, patients should meet the following criteria: For participants with chronic diseases (such as, <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>, <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> mellitus, <a href="https://www.withpower.com/clinical-trials/cystic-fibrosis">cystic fibrosis</a>, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment., For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit., For female participants of childbearing potential: negative <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a> test, adequate contraception or has abstained from all

Phase 2 & 3

Waitlist Available

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366

Awards & highlights

Study Summary

This trial is testing a vaccine for children. It will evaluate how well it works given in 2 or 3 doses, with an optional booster dose.

Who is the study for?

Healthy children aged 6 months to less than 12 years, including those with stable chronic diseases like asthma or diabetes. They must not have had a recent SARS-CoV-2 infection, exposure, or COVID-19 vaccination. Participants should meet specific growth standards and their parents must agree to follow the study's procedures.Check my eligibility

What is being tested?

The trial is testing different doses of mRNA-1273 COVID-19 vaccine in children through intramuscular injections. It will explore the safety and effectiveness of two initial doses plus an optional third dose or booster.See study design

What are the potential side effects?

Possible side effects may include pain at the injection site, fever, fatigue, headache, muscle pain, chills, joint pain and nausea. Side effects are generally mild to moderate but can vary for each child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It looks like the criterion is incomplete. Could you please provide more details or context for me to assist you accurately?

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My child was born full-term and weighed at least 2.5 kg.

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My child's BMI is at or above the 3rd percentile for their age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 57, day 209, day 394, booster dose day 1, booster dose day 29, booster dose day 181, and booster dose day 366 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody

Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody

Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation

+8 more

Secondary outcome measures

GM Value of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb)

GM Value of SARS-CoV-2- Specific Neutralizing Antibody (nAb)

Number of Participants with SARS-CoV-2 Infection Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein in Participants with Negative SARS-CoV-2 at Baseline, in the Absence of Any COVID-19 Symptoms

+2 more

Side effects data

From 2022 Phase 3 trial • 30415 Patients • NCT04470427

Headache

Fatigue

Upper respiratory tract infection

Injection site pain

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Part A (Blinded): Placebo

Part A (Blinded): mRNA-1273

Part B (Open-label): Placebo

Part B (Open-label): Placebo/mRNA-1273

Part B (Open-label): mRNA-1273

Part C: mRNA-1273 Booster

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1273Experimental Treatment2 Interventions

Part 1: Participants will receive 2 IM injections of mRNA-1273 at doses pre-specified for this study, on Days 1 and 29. Participants will be offered an optional BD of mRNA-1273 lower than the dose chosen for primary series, ≥6 months after Dose 2. After protocol amendment (PA) 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214. Part 2: Participants will receive 2 IM injections of mRNA-1273 at dose selected from Part 1 on Days 1 and 29. Participants (6 to <12 year) will be offered an optional BD of mRNA-1273 lower than the dose chosen for primary series, ≥6 months after Dose 2. After PA 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214. Part 3: Participants will receive 2 IM injections of mRNA-1273 on Days 1 and 29 as primary series then 1 IM injection as Dose 3, on Day 149 ≥3 months and ≤5 months after receipt of Dose 2 of primary series. All 3 injections will be administered at lower dose than that of Part 1.

Group II: PlaceboPlacebo Group3 Interventions

Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo on Day 1 and Day 29. Participants (6 to <12 year old) will be offered an optional BD of mRNA-1273 at a dose lower than the dose that was chosen for the primary series for this age group, at least 6 months post-cross-over Dose 2. After PA 9, participants who have not yet received a BD will be offered a BD with mRNA-1273.214.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1273.214

2021

Completed Phase 3

~20920

mRNA-1273

2021

Completed Phase 4

~58700

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

107 Previous Clinical Trials

61,366,175 Total Patients Enrolled

37 Trials studying COVID-19

61,248,616 Patients Enrolled for COVID-19

Media Library

mRNA-1273 (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04796896 — Phase 2 & 3

COVID-19 Research Study Groups: mRNA-1273, Placebo

COVID-19 Clinical Trial 2023: mRNA-1273 Highlights & Side Effects. Trial Name: NCT04796896 — Phase 2 & 3

mRNA-1273 (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04796896 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sets this particular trial apart from others like it?

"Research into mRNA-1273 began in 2020 with a trial sponsored by ModernaTX, Inc. Since the initial Phase 1 study there have been 28 more clinical trials across 22 countries and 219 cities."

Answered by AI

Are there previous examples of mRNA-1273's efficacy?

"Originally, mRNA-1273 was studied in 2020 at Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases. So far, there have been a total of 18283 completed studies. Presently, 28 live trials are underway; many of these based in Port Lavaca, Georgia."

Answered by AI

Are there any sites conducting this research in North America?

"Currently, there are a total of 34 clinical trial sites. These locations include Port Lavaca, Savannah, and Austin. Participants can choose the site that is most convenient for them to help reduce travel time and costs."

Answered by AI

What is the minimum age requirement for participants in this clinical trial?

"Patients that want to enroll in this clinical trial must be between 6 months and 11 years old—a total of 145 studies are for patients younger than 18 whereas 997 are for those over 65."

Answered by AI

Out of the total number of people who qualify, how many will this research project be able to help?

"In order to have statistically significant results, 13575 patients that meet the given inclusion criteria must enroll. Two possible locations for patients to take part in this study are Crossroads Clinical Research (Victoria) located in Port Lavaca, Georgia and iresearch Savannah situated in Savannah, New york."

Answered by AI

Are there any enrolment restrictions for this clinical trial?

"This clinical trial is looking for 13575 people with covid-19 aged 6 Months and 11. Most notable, patients should meet the following criteria: For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment., For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit., For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all"

Answered by AI