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
Purpose
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).
Condition
- SARS-CoV-2
Eligibility
- Eligible Ages
- Between 6 Months and 5 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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. OR - 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. Special inclusion criteria for participants aged 6 months to < 12 months: - The participant was born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg). Inclusion criteria for Part 2: - 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. Inclusion criteria for Part 3 only: - The participant must have received an age-appropriate immunization series of an authorized/approved COVID-19 vaccine, with the last dose given at least 4 months prior to enrolment (Previous vaccines NOT allowed are: XBB.1.5-containing formulation).
Exclusion Criteria
- 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. Note: This excludes influenza vaccine that may be given anytime, but ideally at least 7 days before study dose. If a participant receives an influenza vaccine, this should be captured within the concomitant medication electronic case report form (eCRF). - 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. Note: Other inclusion and exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental mRNA-1273.214 (Part 1) |
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. |
|
|
Experimental mRNA-1273.214 (Part 2) |
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. |
|
|
Experimental mRNA-1273.815 (Part 3) |
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. |
|
|
Experimental mRNA-1273.815 (Part 4) |
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. |
|
Recruiting Locations
Trinity Clinical Research, LLC
Bessemer, Alabama 34020
Bessemer, Alabama 34020
Sera Collection Research Services
Montebello, California 90640
Montebello, California 90640
Prohealth Research Center
Doral, Florida 33166
Doral, Florida 33166
University of Florida Jacksonville
Jacksonville, Florida 32209
Jacksonville, Florida 32209
Kissimmee Clinical Research
Kissimmee, Florida 34741
Kissimmee, Florida 34741
Med-Care Research
Miami, Florida 33125
Miami, Florida 33125
University of South Florida
Tampa, Florida 33612
Tampa, Florida 33612
IResearch
Decatur, Georgia 30030
Decatur, Georgia 30030
Meridian Clinical Research
Macon, Georgia 31210
Macon, Georgia 31210
Velcocity Clinical Research
Meridian, Idaho 83642
Meridian, Idaho 83642
Meridian Clinical Research
Overland Park, Kansas 66210
Overland Park, Kansas 66210
Velocity Clinical Research - Lafayette - PPDS
Lafayette, Louisiana 70508
Lafayette, Louisiana 70508
Velocity Clinical Research - Covington - PPDS
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Clinical Research Institute
Minneapolis, Minnesota 55402
Minneapolis, Minnesota 55402
University of Missouri Health Care
Columbia, Missouri 65212
Columbia, Missouri 65212
Meridian Clinical Research
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
Velocity Clinical Research
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Meridian Clinical Research
Binghamton, New York 13901
Binghamton, New York 13901
Child Healthcare Associates - East Syracuse
East Syracuse, New York 13057
East Syracuse, New York 13057
Velcocity Clinical Research
East Greenwich, Rhode Island 02818
East Greenwich, Rhode Island 02818
Velocity Clinical Research Austin
Austin, Texas 78759
Austin, Texas 78759
REX Clinical Trials, LLC Beaumont
Beaumont, Texas 77701-3739
Beaumont, Texas 77701-3739
Village Health Partners - Frisco Medical Village
Frisco, Texas 75033
Frisco, Texas 75033
Ventavia Research Group
Houston, Texas 77008
Houston, Texas 77008
Cyfair Clinical Reseach Center
Houston, Texas 77065
Houston, Texas 77065
Texas Center for Drug Development
Houston, Texas 77081
Houston, Texas 77081
PI Coor Clinical Research LLC
Burke, Virginia 22015
Burke, Virginia 22015
Clinical Research Partners
Richmond, Virginia 23226
Richmond, Virginia 23226
Caribbean Medical Research Center
San Juan, Puerto Rico 00918
San Juan, Puerto Rico 00918
More Details
- NCT ID
- NCT05436834
- Status
- Recruiting
- Sponsor
- ModernaTX, Inc.
Detailed Description
Part 1 will enroll participants aged 6 months to <6 years who have not been previously vaccinated against SARS-CoV-2. Participants will receive 2 doses of the mRNA-1273.214 vaccine. Part 2 will enroll participants aged 6 months to <6 years who have previously been vaccinated with a mRNA-1273 primary series in Study mRNA-1273-P204 (NCT04796896). Participants will receive a single BD of the mRNA-1273.214 vaccine, at least 4 months after completion of the mRNA-1273 primary series. Part 3 will enroll participants aged 6 months to <6 years who have previously been vaccinated with an authorized/approved COVID-19 vaccine. Participants will receive a BD of the mRNA-1273.815 vaccine at least 4 months after the last receipt of a COVID-19 vaccine. Part 4 will evaluate mRNA-1273.815 vaccine administered as a single dose to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age enrolled in Cohort A (Part 4A), compared to 2 doses given to SARS-CoV-2 vaccine-naïve participants aged 6 months to <2 years enrolled in Cohort B (Part 4B).