A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

NCT04796896 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: mRNA-1273-P204
• Study Type: interventional
• Target: 11,942
• Locations: 2 countries
• Sites: 91

Brief Summary

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).

Conditions

SARS-CoV-2

Keywords

mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna

Outcome Measures

Primary Outcomes (11)

• Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

  Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  7 days post-vaccination

• Parts 1, 2, and 3: Number of Participants With Unsolicited AEs

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately.

  Up to 28 days post-vaccination

• Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study

  An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. AESIs for mRNA-1273 were identified based upon medical concepts that may be related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance. An MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. This included visits to a study site for unscheduled assessments and visits to healthcare practitioners external to the study site. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately.

  Up to 2 years

• Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301

  Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ and values greater than upper limit of quantification (ULOQ) were replaced by ULOQ if actual values were not available. LLOQ was 18.5 arbitrary units (AU)/milliliter (mL) and ULOQ was 45118 AU/mL for ID50 titer. Per-Protocol (PP) Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 and negative serology test based on binding antibody (bAb) specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving highly active antiretroviral therapy (HAART) for participants with HIV; and had no major protocol deviations that impacted key or critical data.

  Day 57 P204/Day 57 P301

• Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

  Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ and values \>ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key/critical data. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed.

  Day 57 P204/Day 57 P301

• Parts 1 and 2: Seroresponse Rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

  Percentage of participants with seroresponse for pseudovirus neutralizing antibody ID50 are reported. Seroresponse: change from below LLOQ to equal above 4\*LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ. LLOQ=18.5 AU/mL and ULOQ=45118 AU/mL for ID50 titer. PP Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 at baseline, not receiving HAART; and had no major protocol deviations that impacted key/critical data. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed.

  Day 57 P204/Day 57 P301

• Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

  Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 and ULOQ AU/mL was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data.

  Day 57 P204/Day 57 P301

• Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301

  Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.

  BD-Day 29 P204/Day 57 P301

• Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

  Antibody values reported as below the LLOQ were replaced by 0.5\*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed.

  Third Dose-Day 29 P204/Day 57 P301

• Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

  Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.

  BD-Day 29 P204/Day 57 P301

• Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

  Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit.

  Third Dose-Day 29 P204/Day 57 P301

Secondary Outcomes (10)

• Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57

  Day 1, Day 57 (1 month after Dose 2)

• Parts 1 and 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29

  Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1 (Pre-booster), BD-Day 29 (1 month after booster dose)

• Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

  Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

• Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57

  Day 1 and Day 57 (1 month after Dose 2)

• Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57

  Day 1 and Day 57 (1 month after Dose 2)

Other Outcomes (1)

• Number of Deaths Related to Study Drug

  Up to 2 years

Study Arms (2)

mRNA-1273

EXPERIMENTAL

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.

Biological: mRNA-1273; Biological: mRNA-1273.214

Placebo

PLACEBO COMPARATOR

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.

Biological: mRNA-1273; Biological: Placebo; Biological: mRNA-1273.214

Interventions

mRNA-1273 BIOLOGICAL

Sterile liquid for injection

Placebo; mRNA-1273

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo

mRNA-1273.214 BIOLOGICAL

Sterile liquid for injection

Placebo; mRNA-1273

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow-up, including all procedures, written informed consent is provided, and participants provide assent.
• 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 children 6 months to \<12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg).
• For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection (Day 29) and the third dose in Part 3 (Day 149/booster dose Day 1), and not currently breastfeeding.

You may not qualify if:

• Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to administration of vaccine.
• Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine.
• Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment.
• Known hypersensitivity to a component of the vaccine or its excipients.
• 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.
• History of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
• Received any non-study vaccine within 14 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
• Received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1
• Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (91)

Children's of Alabama

Birmingham, Alabama, 35233-1711, United States

Location

MedPharmics, LLC

Phoenix, Arizona, 85015-1105, United States

Location

Emmaus Research Center Inc

Anaheim, California, 92804-1866, United States

Location

Velocity Clinical Research - Banning - ERN- PPDS

Banning, California, 92220-3082, United States

Location

SeraCollection Research Services LLC

El Monte, California, 91731, United States

Location

UCSD Altman Clinical and Translational Research Institute Building

La Jolla, California, 92037, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723-5459, United States

Location

Rady Childrens Hospital San Diego - PIN

San Diego, California, 92123, United States

Location

Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT

Ventura, California, 93003-5369, United States

Location

Children's Hospital Colorado - (CRS)

Aurora, Colorado, 80045-7144, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519-1712, United States

Location

Prohealth Research Center

Doral, Florida, 33166, United States

Location

University of Florida Jacksonville

Jacksonville, Florida, 32209-6511, United States

Location

Kissimmee Clinical Research (KCR)

Kissimmee, Florida, 34743, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155-4630, United States

Location

Pensacola Research Consultants Inc. d/b/a Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

University of South Florida

Tampa, Florida, 33613-3946, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322-1014, United States

Location

Iresearch Atlanta, LLC

Decatur, Georgia, 30030-3438, United States

Location

iresearch Savannah

Savannah, Georgia, 31405, United States

Location

Velocity Clinical Research - Boise - ERN - PPDS

Meridian, Idaho, 83642-6246, United States

Location

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611-2991, United States

Location

Alliance for Multispecialty Research -El Dorado

El Dorado, Kansas, 67042-2187, United States

Location

University of Kentucky

Lexington, Kentucky, 40504-3516, United States

Location

Michael W Simon, MD PSC

Lexington, Kentucky, 40517-8366, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70809, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Location

MedPharmics - Platinum

Metairie, Louisiana, 70006-4152, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1519, United States

Location

Javara Inc.

Chevy Chase, Maryland, 20815, United States

Location

The Pediatric Centre of Frederick

Frederick, Maryland, 21702-4747, United States

Location

Tufts University - Boston - PPDS

Boston, Massachusetts, 02111-1552, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2621, United States

Location

Pediatric Associates of Fall River

Fall River, Massachusetts, 02721-1778, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202-2608, United States

Location

Clinical Research Institute, Inc - CRN - PPDS

Minneapolis, Minnesota, 55402-2700, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

MediSync Clinical Research Hattiesburg Clinic

Petal, Mississippi, 39465, United States

Location

University of Missouri Health Care System

Columbia, Missouri, 65212-1000, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110-1010, United States

Location

Meridian Clinical Research (Hastings, Nebraska)

Hastings, Nebraska, 68901, United States

Location

Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS

Norfolk, Nebraska, 68701-2669, United States

Location

Quality Clinical Research - PPDS

Omaha, Nebraska, 68114-3723, United States

Location

MedPharmics, LLC

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106-2719, United States

Location

Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

Binghamton, New York, 13901-1046, United States

Location

Certified Research Associates

Cortland, New York, 13045-9398, United States

Location

Child Healthcare Associates - East Syracuse

East Syracuse, New York, 13057, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642-0001, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-0001, United States

Location

OnSite Clinical Solutions, LLC

Charlotte, North Carolina, 28208, United States

Location

Javara Inc. - Winston-Salem

Winston-Salem, North Carolina, 27101-4263, United States

Location

Cincinnati Children's Hospital Medical Center - PIN

Cincinnati, Ohio, 45229-3026, United States

Location

Lynn Health Science Institute - ERN - PPDS

Oklahoma City, Oklahoma, 73112-4703, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4319, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213-1481, United States

Location

Velocity Clinical Research - Providence - ERN - PPDS

Warwick, Rhode Island, 02886-1617, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414-5834, United States

Location

Medical University of South Carolina- PPDS

Charleston, South Carolina, 29425-8903, United States

Location

Palmetto Pediatrics

North Charleston, South Carolina, 29406-9170, United States

Location

Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department

Nashville, Tennessee, 37208-3501, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-0011, United States

Location

Tekton Research - Texas - Platinum - PPDS

Austin, Texas, 78745, United States

Location

BRCR Global Texas

Edinburg, Texas, 78539-8462, United States

Location

Pininos Pediatric Services

El Paso, Texas, 79902-1139, United States

Location

Ventavia Research Group - Platinum - PPDS

Houston, Texas, 77008-1398, United States

Location

Baylor College of Medicine

Houston, Texas, 77030-3411, United States

Location

West Houston Clinical Research - Hunt

Houston, Texas, 77055-1626, United States

Location

Texas Center for Drug Development, Inc

Houston, Texas, 77081, United States

Location

Cyfair Clinical Research Center - ERN- PPDS

Houston, Texas, 77375-6579, United States

Location

Village Health Partners - HUNT

Plano, Texas, 75024, United States

Location

Victoria Clinical Research

Port Lavaca, Texas, 77901-5531, United States

Location

Javara, Inc.

The Woodlands, Texas, 77382, United States

Location

Crossroads Clinical Research (Victoria)

Victoria, Texas, 77901, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Advanced Clinical Research/Velocity Clinical Research

West Jordan, Utah, 84088, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015-1635, United States

Location

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792-0001, United States

Location

University of Calgary

Calgary, Alberta, T3B 6A8, Canada

Location

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Winnipeg Children's Hospital, HSC-Winnipeg

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3H 1, Canada

Location

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation - Clinic/Outpatient Facility

Toronto, Ontario, M9V 4B4, Canada

Location

McGill University Health Centre-Vaccine Study Centre

Pierrefonds, Quèbec, H9H 4Y6, Canada

Location

Related Publications (5)

• Rostad CA, Campbell JD, Paulsen GC, Ghamloush SS, Xu W, Zheng L, McElrath MJ, De Rosa SC, Girard B, Das R, Anderson EJ, Creech CB. Evaluation of Cellular Immune Responses After mRNA-1273 Vaccination in Children 6 Months to 11 Years of Age. J Infect Dis. 2025 Jun 2;231(5):e945-e955. doi: 10.1093/infdis/jiaf144.

  PMID: 40119775 DERIVED

• Berthaud V, Creech CB, Rostad CA, Carr Q, de Leon L, Dietrich M, Gupta A, Javita D, Nachman S, Pinninti S, Rathore M, Rodriguez CA, Luzuriaga K, Towner W, Yeakey A, Brown M, Zhao X, Deng W, Xu W, Zhou H, Girard B, Kelly R, Slobod K, Anderson EJ, Das R, Miller J, Schnyder Ghamloush S. Safety and Immunogenicity of an mRNA-1273 Booster in Children. Clin Infect Dis. 2024 Dec 17;79(6):1524-1532. doi: 10.1093/cid/ciae420.

  PMID: 39158584 DERIVED

• Anderson EJ, Creech CB, Berthaud V, Piramzadian A, Johnson KA, Zervos M, Garner F, Griffin C, Palanpurwala K, Turner M, Gerber J, Bennett RL, Ali K, Ampajwala M, Berman G, Nayak J, Chronis C, Rizzardi B, Muller WJ, Smith CA, Fuchs G, Hsia D, Tomassini JE, DeLucia D, Reuter C, Kuter B, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Aunins A, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. N Engl J Med. 2022 Nov 3;387(18):1673-1687. doi: 10.1056/NEJMoa2209367. Epub 2022 Oct 19.

  PMID: 36260859 DERIVED

• Creech CB, Anderson E, Berthaud V, Yildirim I, Atz AM, Melendez Baez I, Finkelstein D, Pickrell P, Kirstein J, Yut C, Blair R, Clifford RA, Dunn M, Campbell JD, Montefiori DC, Tomassini JE, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. N Engl J Med. 2022 May 26;386(21):2011-2023. doi: 10.1056/NEJMoa2203315. Epub 2022 May 11.

  PMID: 35544369 DERIVED

• Lynch LR, Clifford H, Ko R, Hache M, Sun W. Primer of COVID-19 Vaccines for the Perioperative Physician. J Neurosurg Anesthesiol. 2022 Jan 1;34(1):101-106. doi: 10.1097/ANA.0000000000000802.

  PMID: 34870630 DERIVED

Related Links

• Click here to access the website, http://www.kidcovestudy.com, for additional information for the study, such as Study Overview, Participation, Site Locations, along with contact numbers for each location for the study.

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273; mRNA-1273.214 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

+1-866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parts 1 and 3 are Open-label; Part 2 Randomized and Observer-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: March 15, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

CA (8); US (83)