Clinical trial NCT04796896: 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
Official title: A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 11942
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Key Inclusion 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.
* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: 7 days post-vaccination
measure: Parts 1, 2, and 3: Number of Participants With Unsolicited AEs
timeFrame: Up to 28 days post-vaccination
measure: 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
timeFrame: Up to 2 years
measure: 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
timeFrame: Day 57 P204/Day 57 P301
measure: 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
timeFrame: Day 57 P204/Day 57 P301
measure: 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
timeFrame: Day 57 P204/Day 57 P301
measure: 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
timeFrame: Day 57 P204/Day 57 P301
measure: 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
timeFrame: BD-Day 29 P204/Day 57 P301
measure: 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
timeFrame: Third Dose-Day 29 P204/Day 57 P301
measure: 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
timeFrame: BD-Day 29 P204/Day 57 P301
measure: 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
timeFrame: Third Dose-Day 29 P204/Day 57 P301
Secondary outcomes:
measure: 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
timeFrame: Day 1, Day 57 (1 month after Dose 2)
measure: 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
timeFrame: Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1 (Pre-booster), BD-Day 29 (1 month after booster dose)
measure: 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
timeFrame: Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181
measure: Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57
timeFrame: Day 1 and Day 57 (1 month after Dose 2)
measure: Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57
timeFrame: Day 1 and Day 57 (1 month after Dose 2)
measure: Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29
timeFrame: Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Day 209 (6 months after Dose 2), BD-Day 1 (Pre-booster), and BD-Day 29 (1 month after booster dose or third dose)
measure: Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181
timeFrame: Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Third Dose-Day 1 (at least 3 months or 6 months after Dose 2), Third Dose-Day 29 (1 month after third dose), and Third Dose-Day 181 (6 months after third dose)
measure: Part 2: Number of Participants With SARS-CoV-2 Infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR)
timeFrame: 14 days after second injection
measure: Part 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys)
timeFrame: 14 days after second injection
measure: Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19)
timeFrame: 14 days after second injection
Other outcomes:
measure: Number of Deaths Related to Study Drug
timeFrame: Up to 2 years
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Anaheim
country: United States
facility: Emmaus Research Center Inc
state: California
city: Banning
country: United States
facility: Velocity Clinical Research - Banning - ERN- PPDS
state: California
city: El Monte
country: United States
facility: SeraCollection Research Services LLC
state: California
city: La Jolla
country: United States
facility: UCSD Altman Clinical and Translational Research Institute Building
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: San Diego
country: United States
facility: Rady Childrens Hospital San Diego - PIN
state: California
city: Ventura
country: United States
facility: Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado - (CRS)
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Doral
country: United States
facility: Prohealth Research Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
city: Kissimmee
country: United States
facility: Kissimmee Clinical Research (KCR)
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants Inc. d/b/a Avanza Medical Research Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Decatur
country: United States
facility: Iresearch Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: iresearch Savannah
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise - ERN - PPDS
state: Idaho
city: Chicago
country: United States
facility: Ann and Robert H Lurie Childrens Hospital of Chicago
state: Illinois
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research -El Dorado
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lexington
country: United States
facility: Michael W Simon, MD PSC
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics - Platinum
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Chevy Chase
country: United States
facility: Javara Inc.
state: Maryland
city: Frederick
country: United States
facility: The Pediatric Centre of Frederick
state: Maryland
city: Boston
country: United States
facility: Tufts University - Boston - PPDS
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Pediatric Associates of Fall River
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc - CRN - PPDS
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
city: Petal
country: United States
facility: MediSync Clinical Research Hattiesburg Clinic
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri Health Care System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Hastings
country: United States
facility: Meridian Clinical Research (Hastings, Nebraska)
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research - PPDS
state: Nebraska
city: Albuquerque
country: United States
facility: MedPharmics, LLC
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Binghamton
country: United States
facility: Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
state: New York
city: Cortland
country: United States
facility: Certified Research Associates
state: New York
city: East Syracuse
country: United States
facility: Child Healthcare Associates - East Syracuse
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Javara Inc. - Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center - PIN
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute - ERN - PPDS
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Warwick
country: United States
facility: Velocity Clinical Research - Providence - ERN - PPDS
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina- PPDS
state: South Carolina
city: North Charleston
country: United States
facility: Palmetto Pediatrics
state: South Carolina
city: Nashville
country: United States
facility: Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Tekton Research - Texas - Platinum - PPDS
state: Texas
city: Edinburg
country: United States
facility: BRCR Global Texas
state: Texas
city: El Paso
country: United States
facility: Pininos Pediatric Services
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group - Platinum - PPDS
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research - Hunt
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc
state: Texas
city: Houston
country: United States
facility: Cyfair Clinical Research Center - ERN- PPDS
state: Texas
city: Plano
country: United States
facility: Village Health Partners - HUNT
state: Texas
city: Port Lavaca
country: United States
facility: Victoria Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Javara, Inc.
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research (Victoria)
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research/Velocity Clinical Research
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Children's Hospital, HSC-Winnipeg
state: Manitoba
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Ottawa
country: Canada
facility: Childrens Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K. Gupta Medicine Professional Corporation - Clinic/Outpatient Facility
state: Ontario
city: Pierrefonds
country: Canada
facility: McGill University Health Centre-Vaccine Study Centre
state: Quebec
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.