COMPLETED

A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age

Conditions

SARS-CoV-2 Coronavirus disease 2019 COVID-19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to \<6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to \<6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age (Part 4).

Official Title

An Open-Label, Phase 3 Study to Evaluate the Safety and Immunogenicity of mRNA Vaccines for SARS-CoV-2 Variants in Participants Aged 6 Months to < 6 Years

Quick Facts

Study Start:2022-06-21

Study Completion:2025-10-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05436834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 5 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* The participant is 6 months to \<6 years for Parts 1, 2, and 3; 2 years to \<5 years for Part 4A; and 6 months to \<2 years for Part 4B at the time of consent (Screening Visit). Note: for Part 1, participant must be at least 6 months old and must not have reached 6 years of age at the time of administration of first dose. For Part 4B, the participant must be at least 6 months old and must not have reached 2 years of age at the time of administration of first dose. * If the participant has a chronic disease (that is, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus \[HIV\] infection), the disease should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion. Stable diseases are those which have had no change in their status or in the medications required to control them in the 6 months prior to Screening Visit. Note: a change in medication for dose optimization (that is, insulin dose changes, adjustments for age-related weight gain), change within class of medication, or reduction in dose are not considered signs of instability. * In the investigator's opinion, the parent(s)/legally authorized representative(s) (LAR\[s\]) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures and provide written informed consent. * The participant is 2 years or older and has a body mass index (BMI) at or above the second percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit. * The participant is less than 2 years of age and the participant's height and weight are both at or above the second percentile according to WHO Child Growth Standards at the Screening Visit. * The participant was born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg). * The participant must have received 2 doses of mRNA-1273, approximately 28 to 35 days apart, as 25-μg primary series, and second dose was given at least 4 months prior to enrollment.	* Has a known history of SARS-CoV-2 infection (that is, reported AE of COVID-19 or asymptomatic SARS-CoV-2 infection during Study mRNA-1273-P204 at the time of rollover into mRNA-1273-P306 or during Part 1 at the time of rollover into Part 3) in the 90 days prior to dosing in this study. * Is acutely ill or febrile 24 hours prior to or at the Screening Visit. Fever is defined as a body temperature ≥ 38.0°Celsius (C)/≥ 100.4°Fahrenheit (F). Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. * For Parts 1 and 4, participant has previously been administered an investigational or approved CoV (that is, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome coronavirus \[MERS-CoV\]) vaccine. For Part 2, participant who received any approved/investigational CoV vaccine are ineligible to participate except for those who received mRNA-1273 (prototype) vaccine. * Has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (including receipt of SARS-CoV-2 monoclonal antibodies for prophylaxis or treatment) within 90 days prior to enrollment. * Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol \[PEG\] or immediate allergic reaction of any severity to polysorbate). * Has a medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results. * Has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety, specifically the following: * Congenital or acquired immunodeficiency, other than well-controlled HIV infection. * Chronic hepatitis or suspected active hepatitis * A bleeding disorder that is considered a contraindication to IM injection or phlebotomy * Dermatologic conditions that could affect local solicited AR assessments * Any prior diagnosis of malignancy (excluding nonmelanoma skin cancer) * Has received the following: * Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to study vaccination or plans to receive such a vaccine through 14 days following study vaccination. * Systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥1 milligrams (mg)/kg/day or ≥ 10 mg/day prednisone equivalent, if participant weighs \>10 kg). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids, and palivizumab are allowed. * Intravenous (IV) or subcutaneous (SC) blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment.

Inclusion Criteria

Exclusion Criteria

* The participant is 6 months to \<6 years for Parts 1, 2, and 3; 2 years to \<5 years for Part 4A; and 6 months to \<2 years for Part 4B at the time of consent (Screening Visit). Note: for Part 1, participant must be at least 6 months old and must not have reached 6 years of age at the time of administration of first dose. For Part 4B, the participant must be at least 6 months old and must not have reached 2 years of age at the time of administration of first dose.
* If the participant has a chronic disease (that is, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus \[HIV\] infection), the disease should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion. Stable diseases are those which have had no change in their status or in the medications required to control them in the 6 months prior to Screening Visit. Note: a change in medication for dose optimization (that is, insulin dose changes, adjustments for age-related weight gain), change within class of medication, or reduction in dose are not considered signs of instability.
* In the investigator's opinion, the parent(s)/legally authorized representative(s) (LAR\[s\]) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures and provide written informed consent.
* The participant is 2 years or older and has a body mass index (BMI) at or above the second percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit.
* The participant is less than 2 years of age and the participant's height and weight are both at or above the second percentile according to WHO Child Growth Standards at the Screening Visit.
* The participant was born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
* The participant must have received 2 doses of mRNA-1273, approximately 28 to 35 days apart, as 25-μg primary series, and second dose was given at least 4 months prior to enrollment.

* Has a known history of SARS-CoV-2 infection (that is, reported AE of COVID-19 or asymptomatic SARS-CoV-2 infection during Study mRNA-1273-P204 at the time of rollover into mRNA-1273-P306 or during Part 1 at the time of rollover into Part 3) in the 90 days prior to dosing in this study.
* Is acutely ill or febrile 24 hours prior to or at the Screening Visit. Fever is defined as a body temperature ≥ 38.0°Celsius (C)/≥ 100.4°Fahrenheit (F). Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
* For Parts 1 and 4, participant has previously been administered an investigational or approved CoV (that is, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome coronavirus \[MERS-CoV\]) vaccine. For Part 2, participant who received any approved/investigational CoV vaccine are ineligible to participate except for those who received mRNA-1273 (prototype) vaccine.
* Has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (including receipt of SARS-CoV-2 monoclonal antibodies for prophylaxis or treatment) within 90 days prior to enrollment.
* Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol \[PEG\] or immediate allergic reaction of any severity to polysorbate).
* Has a medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
* Has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety, specifically the following:
* Congenital or acquired immunodeficiency, other than well-controlled HIV infection.
* Chronic hepatitis or suspected active hepatitis
* A bleeding disorder that is considered a contraindication to IM injection or phlebotomy
* Dermatologic conditions that could affect local solicited AR assessments
* Any prior diagnosis of malignancy (excluding nonmelanoma skin cancer)
* Has received the following:
* Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to study vaccination or plans to receive such a vaccine through 14 days following study vaccination.
* Systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥1 milligrams (mg)/kg/day or ≥ 10 mg/day prednisone equivalent, if participant weighs \>10 kg). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids, and palivizumab are allowed.
* Intravenous (IV) or subcutaneous (SC) blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment.

Contacts and Locations

Study Locations (Sites)

Trinity Clinical Research, LLC

Bessemer, Alabama, 34020

United States

Velcocity Clinical Research

Banning, California, 92220

United States

Sera Collection Research Services

Montebello, California, 90640

United States

Center For Clinical Trials LLC -Paramount

Paramount, California, 90723

United States

University of Colorado

Aurora, Colorado, 80045

United States

Meridian Clinical Research

Washington D.C., District of Columbia, 20016

United States

Prohealth Research Center

Doral, Florida, 33166

United States

University of Florida Jacksonville

Jacksonville, Florida, 32209

United States

Kissimmee Clinical Research

Kissimmee, Florida, 34741

United States

Med-Care Research

Miami, Florida, 33125

United States

University of South Florida

Tampa, Florida, 33612

United States

IResearch

Decatur, Georgia, 30030

United States

Meridian Clinical Research

Macon, Georgia, 31210

United States

Velcocity Clinical Research

Meridian, Idaho, 83642

United States

Lurie Childrens Hospital

Chicago, Illinois, 60611

United States

Meridian Clinical Research

Overland Park, Kansas, 66210

United States

Michael W. Simon MD, PSC

Lexington, Kentucky, 40517

United States

University of Kentucky

Lexington, Kentucky, 40536

United States

Velocity Clinical Research - Lafayette - PPDS

Lafayette, Louisiana, 70508

United States

MedPharmics

Metairie, Louisiana, 70006

United States

Velocity Clinical Research - Covington - PPDS

Metairie, Louisiana, 70006

United States

Clinical Research Institute

Minneapolis, Minnesota, 55402

United States

University of Missouri Health Care

Columbia, Missouri, 65212

United States

Meridian Clinical Research

Hastings, Nebraska, 68901

United States

Meridian Clinical Research

Lincoln, Nebraska, 68510

United States

Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS

Lincoln, Nebraska, 68516

United States

Quality Clinical Research

Omaha, Nebraska, 68114

United States

Velocity Clinical Research

Albuquerque, New Mexico, 87102

United States

Meridian Clinical Research

Binghamton, New York, 13901

United States

WellNow Urgent Care Clinical Research

East Amherst, New York, 14051

United States

Child Healthcare Associates - East Syracuse

East Syracuse, New York, 13057

United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112

United States

Velcocity Clinical Research

East Greenwich, Rhode Island, 02818

United States

Coastal Pediatric Associates

Charleston, South Carolina, 29414

United States

Meridian Clinical Research

Charleston, South Carolina, 29414

United States

MUSC

Charleston, South Carolina, 29425

United States

Le Bonheur Childrens Hospital

Memphis, Tennessee, 38105

United States

Velocity Clinical Research Austin

Austin, Texas, 78759

United States

REX Clinical Trials, LLC Beaumont

Beaumont, Texas, 77701-3739

United States

Velcocity Clinical Research

Cedar Park, Texas, 78613

United States

BRCR Global Texas

Edinburg, Texas, 78539

United States

Village Health Partners - Frisco Medical Village

Frisco, Texas, 75033

United States

Ventavia Research Group

Houston, Texas, 77008

United States

Cyfair Clinical Reseach Center

Houston, Texas, 77065

United States

Texas Center for Drug Development

Houston, Texas, 77081

United States

Victoria Clinical Research Group

Victoria, Texas, 77901

United States

PI Coor Clinical Research LLC

Burke, Virginia, 22015

United States

Clinical Research Partners

Richmond, Virginia, 23226

United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-21

Study Completion Date2025-10-20

Study Record Updates

Study Start Date2022-06-21

Study Completion Date2025-10-20

Terms related to this study

Keywords Provided by Researchers

Coronavirus disease 2019
COVID-19

Additional Relevant MeSH Terms

SARS-CoV-2