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

SARS-CoV-2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796896
• Other study ID #: mRNA-1273-P204
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 15, 2021
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 11950
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• mRNA-1273
Sterile liquid for injection
• Placebo
0.9% sodium chloride (normal saline) injection
• mRNA-1273.214
Sterile liquid for injection

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	Childrens Hospital of Eastern Ontario	Ottawa	Ontario
Canada	McGill University Health Centre-Vaccine Study Centre	Pierrefonds	Quebec
Canada	Dr. Anil K. Gupta Medicine Professional Corporation - Clinic/Outpatient Facility	Toronto	Ontario
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario
Canada	Children's and Women's Health Centre of British Columbia	Vancouver	British Columbia
Canada	Winnipeg Children's Hospital, HSC-Winnipeg	Winnipeg	Manitoba
United States	MedPharmics, LLC	Albuquerque	New Mexico
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emmaus Research Center Inc	Anaheim	California
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Children's Hospital Colorado - (CRS)	Aurora	Colorado
United States	Tekton Research - Texas - Platinum - PPDS	Austin	Texas
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Velocity Clinical Research - Banning - ERN- PPDS	Banning	California
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Meridian Clinical Research (Endwell-New York) - Platinum - PPDS	Binghamton	New York
United States	Children's of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts University - Boston - PPDS	Boston	Massachusetts
United States	PI-Coor Clinical Research, LLC	Burke	Virginia
United States	Coastal Pediatric Associates	Charleston	South Carolina
United States	Medical University of South Carolina- PPDS	Charleston	South Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Javara Inc.	Chevy Chase	Maryland
United States	Ann and Robert H Lurie Childrens Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center - PIN	Cincinnati	Ohio
United States	University of Missouri Health Care System	Columbia	Missouri
United States	Certified Research Associates	Cortland	New York
United States	Iresearch Atlanta, LLC	Decatur	Georgia
United States	Henry Ford Health System	Detroit	Michigan
United States	Prohealth Research Center	Doral	Florida
United States	Child Healthcare Associates - East Syracuse	East Syracuse	New York
United States	BRCR Global Texas	Edinburg	Texas
United States	Alliance for Multispecialty Research -El Dorado	El Dorado	Kansas
United States	SeraCollection Research Services LLC	El Monte	California
United States	Pininos Pediatric Services	El Paso	Texas
United States	Pediatric Associates of Fall River	Fall River	Massachusetts
United States	The Pediatric Centre of Frederick	Frederick	Maryland
United States	Meridian Clinical Research (Hastings, Nebraska)	Hastings	Nebraska
United States	Baylor College of Medicine	Houston	Texas
United States	Cyfair Clinical Research Center - ERN- PPDS	Houston	Texas
United States	Texas Center for Drug Development, Inc	Houston	Texas
United States	Ventavia Research Group - Platinum - PPDS	Houston	Texas
United States	West Houston Clinical Research - Hunt	Houston	Texas
United States	University of Florida Jacksonville	Jacksonville	Florida
United States	Kissimmee Clinical Research (KCR)	Kissimmee	Florida
United States	UCSD Altman Clinical and Translational Research Institute Building	La Jolla	California
United States	Tanner Clinic	Layton	Utah
United States	Michael W Simon, MD PSC	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Velocity Clinical Research - Boise - ERN - PPDS	Meridian	Idaho
United States	MedPharmics - Platinum	Metairie	Louisiana
United States	Allied Biomedical Research Institute	Miami	Florida
United States	Clinical Research Institute, Inc - CRN - PPDS	Minneapolis	Minnesota
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota
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	Yale University School of Medicine	New Haven	Connecticut
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS	Norfolk	Nebraska
United States	Palmetto Pediatrics	North Charleston	South Carolina
United States	Lynn Health Science Institute - ERN - PPDS	Oklahoma City	Oklahoma
United States	Quality Clinical Research - PPDS	Omaha	Nebraska
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Pensacola Research Consultants Inc. d/b/a Avanza Medical Research Center	Pensacola	Florida
United States	MediSync Clinical Research Hattiesburg Clinic	Petal	Mississippi
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	MedPharmics, LLC	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Village Health Partners - HUNT	Plano	Texas
United States	Victoria Clinical Research	Port Lavaca	Texas
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Rady Childrens Hospital San Diego - PIN	San Diego	California
United States	iresearch Savannah	Savannah	Georgia
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	University of South Florida	Tampa	Florida
United States	Javara, Inc.	The Woodlands	Texas
United States	Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT	Ventura	California
United States	Crossroads Clinical Research (Victoria)	Victoria	Texas
United States	Velocity Clinical Research - Providence - ERN - PPDS	Warwick	Rhode Island
United States	Advanced Clinical Research/Velocity Clinical Research	West Jordan	Utah
United States	Javara Inc. - Winston-Salem	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 156 (7 days after each injection)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 177 (28 days after each injection)
Primary	Number of Participants with Medically-Attended AEs (MAAEs)		Up to Day 514 (1 year after booster dose)
Primary	Number of Participants with Serious Adverse Events (SAEs)		Up to Day 514 (1 year after booster dose)
Primary	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)
Primary	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)
Primary	Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19	Threshold of protection as predefined for study.	Day 57 (1 month after second injection)
Primary	Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody		Day 57 (1 month after second injection)
Primary	Seroresponse Rate of Vaccine Recipients		Day 57 (1 month after second injection)
Primary	GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody		Day 149 (post third dose)
Primary	Seroresponse Rate of Post-Booster Dose of Vaccine Recipients		Day 149 (post third dose)
Secondary	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
Secondary	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
Secondary	Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)	Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.	Up to Day 394
Secondary	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
Secondary	Number of Participants with a First Occurrence of COVID-19	Clinical signs indicative of COVID-19 as predefined for the study.	Up to Day 394

External 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.