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
- Conditions
- SARS-CoV-2
- Interventions
- Biological: mRNA-1273Biological: mRNA-1273.214Biological: Placebo
- Registration Number
- NCT04796896
- Lead Sponsor
- ModernaTX, Inc.
- 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).
- Detailed Description
This is a Phase 2/3, 3-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years.
Please access http://www.kidcovestudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11950
- 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.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mRNA-1273 mRNA-1273.214 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. Placebo mRNA-1273.214 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. mRNA-1273 mRNA-1273 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. Placebo mRNA-1273 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. Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Serious Adverse Events (SAEs) Up to Day 514 (1 year after booster dose) Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation Day 149 (booster dose Day 1) through the last day of study participation (Day 514) Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody Day 57 (1 month after second injection) Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 177 (28 days after each injection) Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 156 (7 days after each injection) Number of Participants with Medically-Attended AEs (MAAEs) Up to Day 514 (1 year after booster dose) Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis Up to Day 514 (1 year after booster dose) Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19 Day 57 (1 month after second injection) Threshold of protection as predefined for study.
Seroresponse Rate of Post-Booster Dose of Vaccine Recipients Day 149 (post third dose) Seroresponse Rate of Vaccine Recipients Day 57 (1 month after second injection) GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody Day 149 (post third dose)
- Secondary Outcome Measures
Name Time Method GM Value of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb) 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 GM Value of SARS-CoV-2- Specific Neutralizing Antibody (nAb) 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 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 Up to Day 394 Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Up to Day 394 Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
Number of Participants with a First Occurrence of COVID-19 Up to Day 394 Clinical signs indicative of COVID-19 as predefined for the study.
Trial Locations
- Locations (90)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
West Houston Clinical Research - Hunt
🇺🇸Houston, Texas, United States
Clinical Research Institute, Inc - CRN - PPDS
🇺🇸Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center - PIN
🇺🇸Cincinnati, Ohio, United States
Emmaus Research Center Inc
🇺🇸Anaheim, California, United States
Velocity Clinical Research - Banning - ERN- PPDS
🇺🇸Banning, California, United States
SeraCollection Research Services LLC
🇺🇸El Monte, California, United States
UCSD Altman Clinical and Translational Research Institute Building
🇺🇸La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Rady Childrens Hospital San Diego - PIN
🇺🇸San Diego, California, United States
Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT
🇺🇸Ventura, California, United States
Prohealth Research Center
🇺🇸Doral, Florida, United States
University of Florida Jacksonville
🇺🇸Jacksonville, Florida, United States
Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
Kissimmee Clinical Research (KCR)
🇺🇸Kissimmee, Florida, United States
Pensacola Research Consultants Inc. d/b/a Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Iresearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
iresearch Savannah
🇺🇸Savannah, Georgia, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Our Lady of the Lake Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
The Pediatric Centre of Frederick
🇺🇸Frederick, Maryland, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Minnesota Masonic Children's Hospital
🇺🇸Minneapolis, Minnesota, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
🇺🇸Norfolk, Nebraska, United States
Certified Research Associates
🇺🇸Cortland, New York, United States
Child Healthcare Associates - East Syracuse
🇺🇸East Syracuse, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
OnSite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Velocity Clinical Research - Providence - ERN - PPDS
🇺🇸Warwick, Rhode Island, United States
Palmetto Pediatrics
🇺🇸North Charleston, South Carolina, United States
BRCR Global Texas
🇺🇸Edinburg, Texas, United States
Pininos Pediatric Services
🇺🇸El Paso, Texas, United States
Ventavia Research Group - Platinum - PPDS
🇺🇸Houston, Texas, United States
Texas Center for Drug Development, Inc
🇺🇸Houston, Texas, United States
Cyfair Clinical Research Center - ERN- PPDS
🇺🇸Houston, Texas, United States
Village Health Partners - HUNT
🇺🇸Plano, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Victoria Clinical Research
🇺🇸Port Lavaca, Texas, United States
Javara, Inc.
🇺🇸The Woodlands, Texas, United States
Crossroads Clinical Research (Victoria)
🇺🇸Victoria, Texas, United States
Advanced Clinical Research/Velocity Clinical Research
🇺🇸West Jordan, Utah, United States
PI-Coor Clinical Research, LLC
🇺🇸Burke, Virginia, United States
Children's and Women's Health Centre of British Columbia
🇨🇦Vancouver, British Columbia, Canada
The Hospital for Sick Children (SickKids)
🇨🇦Toronto, Ontario, Canada
Childrens Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Winnipeg Children's Hospital, HSC-Winnipeg
🇨🇦Winnipeg, Manitoba, Canada
McGill University Health Centre-Vaccine Study Centre
🇨🇦Pierrefonds, Quebec, Canada
Alliance for Multispecialty Research -El Dorado
🇺🇸El Dorado, Kansas, United States
Pediatric Associates of Fall River
🇺🇸Fall River, Massachusetts, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
MediSync Clinical Research Hattiesburg Clinic
🇺🇸Petal, Mississippi, United States
Velocity Clinical Research - Boise - ERN - PPDS
🇺🇸Meridian, Idaho, United States
Tufts University - Boston - PPDS
🇺🇸Boston, Massachusetts, United States
Meridian Clinical Research (Hastings, Nebraska)
🇺🇸Hastings, Nebraska, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
MedPharmics - Platinum
🇺🇸Metairie, Louisiana, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
Children's of Alabama
🇺🇸Birmingham, Alabama, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Quality Clinical Research - PPDS
🇺🇸Omaha, Nebraska, United States
Lynn Health Science Institute - ERN - PPDS
🇺🇸Oklahoma City, Oklahoma, United States
Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Dr. Anil K. Gupta Medicine Professional Corporation - Clinic/Outpatient Facility
🇨🇦Toronto, Ontario, Canada
University of Missouri Health Care System
🇺🇸Columbia, Missouri, United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
🇺🇸Binghamton, New York, United States
Children's Hospital Colorado - (CRS)
🇺🇸Aurora, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Javara Inc. - Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina- PPDS
🇺🇸Charleston, South Carolina, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Coastal Pediatric Associates
🇺🇸Charleston, South Carolina, United States
Javara Inc.
🇺🇸Chevy Chase, Maryland, United States
MedPharmics, LLC
🇺🇸Albuquerque, New Mexico, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Michael W Simon, MD PSC
🇺🇸Lexington, Kentucky, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Tekton Research - Texas - Platinum - PPDS
🇺🇸Austin, Texas, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States