Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    pediatric | mRNA1273
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04796896
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE March 11, 2021
First Posted Date  ICMJE March 15, 2021
Last Update Posted Date October 13, 2021
Actual Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date June 12, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2021)
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after each injection) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after each injection) ]
  • Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 394 (1 year after second injection) ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 394 (1 year after second injection) ]
  • Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis [ Time Frame: Up to Day 394 (1 year after second injection) ]
  • Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19 [ Time Frame: Day 57 (1 month after second injection) ]
    Threshold of protection as predefined for study.
  • Geometric Mean (GM) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody [ Time Frame: Day 57 (1 month after second injection) ]
  • Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (1 month after second injection) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2021)
  • Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after second dose) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (1 month after second dose) ]
  • Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  • Number of Participants with Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection from COVID-19 [ Time Frame: Day 57 (1 month after second dose) ]
    Threshold of protection as predefined for study.
  • Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Day 57 (1 month after second dose) ]
  • Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (1 month after second dose) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • GM of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb) [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
  • GM of SARS-CoV-2- Specific Neutralizing Antibody (nAb) [ Time Frame: Day 1, Day 57, Day 209, and 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) [ Time Frame: Up to Day 394 ]
    Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
  • 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 [ Time Frame: Up to Day 394 ]
  • Number of Participants with a First Occurrence of COVID-19 [ Time Frame: Up to Day 394 ]
    Clinical signs indicative of COVID-19 as predefined for the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2021)
  • GM of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb) [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
  • GM of SARS-CoV-2 Specific nAb [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
  • Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology Starting 14 Days After the Second Dose [ Time Frame: Day 43 to Day 394 ]
    Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
  • Number of Participants with Asymptomatic SARS-CoV-2 Infections [ Time Frame: Up to Day 394 ]
  • Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose [ Time Frame: Day 43 to Day 394 ]
    Clinical signs indicative of COVID-19 as predefined for the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE A Phase 2/3, Two-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
Brief Summary The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses, 28 days apart.
Detailed Description

This is a Phase 2/3, 2-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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part 1 is Open-label; Part 2 Randomized and Observer-blind
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Biological: mRNA-1273
    Sterile liquid for injection
  • Biological: Placebo
    0.9% sodium chloride (normal saline) injection
Study Arms  ICMJE
  • Experimental: mRNA-1273

    Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at up to 3 doses pre-specified for this study, 28 days apart, on Day 1 and Day 29.

    Part 2: Participants will receive 2 IM injections of mRNA-1273 at the dose selected from Part 1, 28 days apart, on Day 1 and Day 29.

    Intervention: Biological: mRNA-1273
  • Placebo Comparator: Placebo
    Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2021)
13275
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2021)
750
Estimated Study Completion Date  ICMJE June 12, 2023
Estimated Primary Completion Date June 12, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04796896
Other Study ID Numbers  ICMJE mRNA-1273-P204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ModernaTX, Inc.
Study Sponsor  ICMJE ModernaTX, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP